Press release

Malmö, Sweden, February 25, 2021

Download the press release as PDF here

PILA PHARMA AB (publ) announces that CEO Dorte X. Gram on Monday and Tuesday, February 21 and 22, bought 18,878 shares in the company. The shares were purchased at an average price of SEK 5.39. The transaction took place through the company Gram Equity Invest, which she owns together with her son Gustav Hanghøj Gram.

Dorte X. Gram is the main owner of PILA PHARMA and after Monday’s and Tuesday’s acquisitions, she owns a total of 5,050,458 shares via companies, which corresponds to just over 31 percent of votes and capital.

”I increased my holding in November and now continue to buy shares in PILA PHARMA because at the current price of PILA PHARMA’s share, I can not see any better investment than this, despite the uncertain situation on the stock exchange in general. I am convinced that we at PILA PHARMA have a very good drug candidate for type 2 diabetes and our development from startup to an international company is going according to the plan we have communicated to the stock market”, says Dorte X. Gram

For more information: 

Dorte X. Gram, CEO
M: +46 (0)73 903 6969
E: dxg@pilapharma.com

About PILA PHARMA (Publ)

PILA PHARMA is a Swedish biotech company in the diabetes segment based in Malmö. The aim of the company is to develop a novel and superior tablet based treatment for type 2 diabetes. The company owns both use patents for treating diabetes and obesity with TRPV1 antagonists, and the intellectual property rights for the mid stage clinical development candidate XEN-D0501. The company is listed at Nasdaq First North GM in Stockholm in July 2021 to finance the further development of XEN-D0501. Currently, new API for further 3 months preclinical safety studies is being manufactured to permit the company to progress XEN-D0501 to a pivotal 3 month phase 2b trial in patients with diabetes, scheduled to start in first part of 2023.

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a highly selective and very potent small molecule TRPV1 antagonist, previously in development by Bayer Healthcare and Xention/Ario Pharma. The TRPV1 target (also called the “chili-receptor”) has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes as well. XEN-D0501 was acquired by PILA PHARMA in March 2016, due to its very good safety and tolerability profile as compared to other clinical TRPV1-antagonist development candidates. TRPV1 antagonists as a drug-class has previously been associated with severe adverse events as fever (hyperthermia) but this has not been the case for XEN-D0501 in 8 clinical trials conducted so far. The maximal tolerable dose in non-diabetic individuals has previously been determined to be 4 milligrams twice daily, a dose level with good safety but no effect in non-diabetic patients with either overactive bladder disease or chronic cough. In November 2018, PILA PHARMA reported the completion of its first clinical trial (PP-CT01), demonstrating a good safety profile of XEN-D0501 at single doses up to 8 milligrams when administered to people with type 2 diabetes. The most recent study results were announced in September 2020. The study (PP-CT02) demonstrated that multiple doses of XEN-D0501 (4 milligrams twice daily for 28 days) were likewise well-tolerated by people with type 2 diabetes and also – with statistical significance versus placebo – that XEN-D0501 enhances the endogenous insulin response to oral glucose, thus demonstrating proof of principle.

About diabetes

Diabetes is a world-wide pandemic with a staggering prevalence of 537 million diabetics corresponding to approximately 8-10% of the population. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes. The disease can lead to cardiovascular disease resulting in reduction of quality of life for the patient, increased risk of death and high health care expenses. Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, accessibility and affordability perspective.

Malmö, 25 februari, 2022

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PILA PHARMA AB (publ) meddelar att VD Dorte X. Gram under måndagen och tisdagen den 21 och 22 februari köpt 18 878 aktier i bolaget. Aktierna köptes till en snittkurs om 5,39 SEK. Affären har skett genom bolaget Gram Equity Invest som hon äger tillsammans med sin son Gustav Hanghøj Gram.

Dorte X. Gram är sedan tidigare huvudägare i PILA PHARMA och efter måndagens och tisdagens förvärv äger hon via bolag totalt 5 050 458 aktier vilket motsvarar drygt 31 procent av röster och kapital.

”Jag ökade innehavet i november och fortsätter nu köpa aktier i PILA PHARMA eftersom jag vid nuvarande kurs i PILA PHARMA:s aktie inte kan se någon bättre placering än denna, trots det osäkra läget på börsen generellt. Jag är övertygad om att vi i PILA PHARMA har en mycket bra läkemedelskandidat för typ 2-diabetes och vår utveckling från startup till ett internationellt bolag går enligt den plan som vi kommunicerat till aktiemarknaden”, säger Dorte X. Gram.

För mer information: 

Dorte X. Gram, CEO
M: +46 (0)73 903 6969
E: dxg@pilapharma.com

Om PILA PHARMA (PUBL)

PILA PHARMA är ett svenskt bioteknik-företag inom diabetesforskning med säte i Malmö. Bolagets mål är att utveckla en överlägsen ny medicin i tablettform mot typ 2-diabetes. Bolaget äger användarpatent för behandling av diabetes och fetma med TRPV1-antagonister samt immateriella rättigheter för utvcekling av produktkandidaten XEN-D0501. Bolaget noterades på Nasdaq First North GM i Stockholm i juli 2021 i syfte att finansiera den fortsatta utvecklingen av XEN-D0501. För närvarande tillverkas API för ytterligare tre månaders prekliniska studier för att medge bolaget att gå vidare den huvudsakliga tre månaders fas 2b-studien i diabetespatienter. Studien är planerad att starta under första delen av 2023.

Om XEN-D0501 och TRPV1-antagonister

XEN-D0501 är en mycket selektiv och potent liten molekyl, en TRPV1-antagonist, som  tidigare utvecklades av Bayer Healthcare och Xention/Ario Pharma. TRPV1-receptorn (även kallad chilireceptorn) har visat sig ha en roll vid smärta och inflammatoriska sjukdomar och tros även spela en roll vid diabetes. XEN-D0501 förvärvades av PILA PHARMA i mars 2016 på grund av sin mycket goda säkerhets- och biverkningsprofil jämfört med andra TRPV1-antagonister. TRPV1-antagonister som läkemedelsklass har tidigare förknippats med allvarliga biverkningar som till exempel hypertermi (feber) men det har hittills inte varit fallet med XEN-D0501 i åtta kliniska studier. Den maximala tolerabla dosen av XEN-D0501 för icke-diabetiska individer har tidigare satts till 4 milligram två gånger dagligen där man noterade god säkerhet men ingen effekt i inte-diabetiska patienter med överaktiv urinblåsa och kronisk hosta. I november 2018 kunde PILA PHARMA presentera den första kliniska studien (PP-CT01), som visade upp en god säkerhetsprofil av XEN-D0501vid enstaka doser upp till 8 milligram. Det senaste studieresultatet presenterades i september 2020. Studien (PP-CT02) visade att multipla doser av XEN-D0501 (4 mg två gånger dagligen i 28 dagar) också tolererades väl av patienter med typ 2-diabetes. Därutöver visade studien, med statistisk signifikans jämfört med placebo, att XEN-D0501 stimulerar kroppens insulinrespons vid ett oralt intag av glukos (socker), alltså bevis för mekanismen i insulinreglering (proof of principle).

Om diabetes

Diabetes är en global pandemi med ofattbara 537 miljoner diabetiker vilket motsvarar uppskattningsvis 8-10 procent av världens befoklning. Uppskattningsvis har 90 procent av alla diabetiker typ 2-diabetes, medan cirka 10 procent har typ 1-diabetes. Sjukdomen kan leda till hjärt-kärlsjukdomar som minskar patientens livskvalitet, öka risken för dödsfall samt höga sjukvårdskostnader. Trots att stora framsteg gjorts med behandling av diabetes återstår ett stort omättat behov av behandlingar som är effektiva, säkra och tillgängliga och prisvärda. 

Malmö, Sweden, October 5, 202

Download the press release as PDF here

On Monday, October 4, the Nobel Assembly at Karolinska Institutet announced that the 2021 Nobel prize in Physiology or Medicine goes to the scientists David Julius and Ardem Patapoutian, both active at universities in the USA.

The two scientists are jointly rewarded “for their discoveries of receptors for temperature and touch”. One of the receptors that they have discovered is the TRPV1 receptor, which is thanks to David Julius reseach known to react to pain and painful heat and cause the heat sensation.

PILA PHARMA a Swedish Biotech company, listed on Nasdaq First North GM Sweden, is using the TRPV1 receptor as the leading principle for a novel treatment of diabetes. This is done by developing a TRPV1 antagonist, (XEN-D0501), and in that way get the body to regulate insulin secretion and get a better glucose tolerance.

Dr. Julius used capsaicin, the hot ingredient in chili, to identify the responsive DNA fragment or gene in sensory nerves. This gene was later cloned and first named the capsaicin receptor and later VR1 and then TRPV1. Popularly, we in PILA PHARMA call it the ‘chili-receptor’.

By means of creating a TRPV1 knock out mouse (a normal mouse, but without the TRPV1), the research group of Dr. Julius showed that TRPV1 plays a significant role in the sensation of pain.

“It’s fantastic news to learn that, yesterday, the Nobel prize went to to ‘our’ TRPV1 receptor. I’m a true fan of Dr. Julius, and I used his TRPV1 knock-out mice to first demonstrate TRPV1’s specific role in diabetes via regulation of insulin secretion and glucose tolerance! Results that we recently replicated in subjects with type 2 diabetes! With the Nobel prize committees honourable validation of TRPV1 as an important molecular target we look even more forward to further progress our TRPV1 antagonist to phase 2b tests in diabetes”, says founder and CEO, Dorte X. Gram.

Link to our patentapplication based on the TRPV1 knock out data:
https://worldwide.espacenet.com/patent/search/family/035134546/publication/WO2006007851A2?q=capsaicin%20gram

Link to the resulting publication: https://pubmed.ncbi.nlm.nih.gov/31344877

For more information:

Dorte X. Gram, CEO                                                          
M: +46 (0)73 903 6969
E: dxg@pilapharma.com

About PILA PHARMA

PILA PHARMA is a Swedish biotech company in the diabetes segment based in Malmö. The aim of the company is to develop a novel and superior tablet based treatment for type 2 diabetes. The company owns both use patents for treating diabetes and obesity with TRPV1 antagonists, and the intellectual property rights for the mid stage clinical development candidate XEN-D0501.

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a highly selective and very potent small molecule TRPV1 antagonist, previously in development by Bayer Healthcare and Xention/Ario Pharma. The TRPV1 target (also called the “chili-receptor”) has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes as well. XEN-D0501 was acquired by PILA PHARMA in March 2016, due to its very good safety and tolerability as compared to other clinical TRPV1-antagonist development candidates. TRPV1 antagonists as a drug-class has previously been associated with severe adverse events as fever (hyperthermia). The maximum tolerable dose in non-diabetic individuals has previously been determined to be 4 milligrams twice daily, a dose level with good safety but no effect in non-diabetic patients with either overactive bladder disease or chronic cough. In November 2018, PILA PHARMA reported the completion of its first clinical trial, PP-CT01, demonstrating good safety of XEN-D0501 at single doses up to 8 milligrams when administered to people with type 2 diabetes. The most recent study results were announced in September 2020. The study (PP-CT02) demonstrated that multiple doses of XEN-D0501 (4 mg twice daily for 28 days) were likewise safe and well-tolerated by people with type 2 diabetes and also – with statistical significance versus placebo – that XEN-D0501 enhances the endogenous insulin response to oral glucose, thus demonstrating proof of principle.

About diabetes

Diabetes is a world-wide pandemic with a staggering prevalence of 463 million diabetics corresponding to approximately 8-10% of the population. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes. The disease can lead to cardiovascular disease resulting in reduction of quality of life for the patient, increased risk of death and high health care expenses. Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, adherence, accessibility and affordability perspective.

Malmö, 5 oktober, 2021

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På måndagen den 4 oktober meddelande Nobelförsamlingen vid Karolinska Insitutet att 2021 års Nobelpris i fysiologi eller medicin går till David Julius och Ardem Patapoutian, båda vetenskapsmän aktiva vid universitet i USA.

De båda tilldelas priset ”för deras upptäckter av receptorer för temperatur och beröring”. En av de receptorer som de hittat är TRPV1-receptorn, som tack vare David Julius forskning är känd för att reagera på smärta och smärtsam värme samt för att skapa kroppens smärt- och värmekänsla.

PILA PHARMA, ett svenskt biotek-företag, noterat på Nasdaq Fist North GM, använder TRPV1-receptorn som ledande princip för en ny behandling av diabetes. Detta görs genom att utveckla en TRPV1-antagonist, (XEN-D0501), för att på så sätt få kroppen att reglera insulinnivån och få en bättre glukostolerans.

David Julius använde kapsaicin, det ämne i chilipeppar som ger chili stark smak, för att identifiera det DNA-fragment, eller gen, som reglerar känselstimuli i känselnerver. Denna gen klonades senare och kallades först kapsaicin-receptorn, senare VR1 och därefter TRPV1. På PILA PHARMA kallas receptorn populärt för ”chilireceptorn”.

Genom att ta skapa en ”knock out-mus”, en mus med TRPV1-receptorn borttagen, kunde David Julius forskarteam visa att TRPV1 spelar en viktig roll vid förnimmelsen av smärta.

“Det är en fantastisk nyhet att årets Nobelpris går till ”vår” TRPV1-receptor. Jag är ett sant David Julius-fan och jag har själv använt hans knock out-möss för att visa på TRPV1:s roll i diabetes genom reglering av insulinnivå och glukostolerans. Detta är resultat som vi har upprepat i människor med typ 2-diabetes. Med Nobelkommitténs erkännande av TRVP1 som ett viktigt molekylärt mål ser vi ännu mer fram emot att ta vår TRPV1-antagonist vidare i fas 2b-tester mot typ 2-diabetes”, säger PILA PHARMAS grundare och VD, Dorte X. Gram.

Länk till PILA PHARMA:s patentansökan, baserad på TRPV1 knock out-data: https://worldwide.espacenet.com/patent/search/family/035134546/publication/WO2006007851A2?q=capsaicin%20gram

Länk till den följande publikationen: https://pubmed.ncbi.nlm.nih.gov/31344877

För mer information:

Dorte X. Gram, CEO
M: +46 (0)73 903 6969
E: dxg@pilapharma.com

Om PILA PHARMA

PILA PHARMA är ett svenskt bioteknik-företag inom diabetesforskning med säte i Malmö. Bolagets mål är att utveckla en överlägsen ny medicin i tablettform mot typ 2-diabetes. Bolaget äger användarpatent för behandling av diabetes och fetma med TRPV1-antagonister samt immateriella rättigheter för utvcekling av produktkandidaten XEN-D0501.

Om XEN-D0501 och TRPV1-antagonister

XEN-D0501 är en mycket selektiv och potent liten molekyl, en TRPV1-antagonist, som tidigare utvecklades av Bayer Healthcare och Xention/Ario Pharma.TRPV1-receptorn (även kallad chilireceptorn) har visat sig ha en roll vid smärta och inflammatoriska sjukdomar och tros även spela en roll vid diabetes. PILA PHARMA förvärvade XEN-D0501 i mars 2016 eftersom molekylen i tester visat upp mycket god säkerhet jämfört med andra TRPV1-antagonister i klinisk fas.

TRPV1-antagonister som läkemedelsklass har tidigare förknippats med allvarliga biverkningar som till exempel hypertermi (feber). Den maximala dosen av XEN-D0501 för icke-diabetiska individer har tidigare satts till 4 milligram två gånger dagligen där man noterade god säkerhet men ingen effekt i inte-diabetiska patienter med överaktiv urinblåsa och kronisk hosta. 

I november 2018 kunde PILA PHARMA presentera den första kliniska studien (PP-CT01) där typ 2-diabetespatienter fått XEN-D0501. Studien visade upp god säkerhet upp till 8 milligram vid en enda dos. Det senaste studieresultatet presenterades i september 2020. Studien (PP-CT02) visade att multipla doser av XEN-D0501 (4 mg två gånger dagligen i 28 dagar) också tolererades väl av patienter med typ 2-diabetes. Därutöver visade studien, med statistisk signifikans jämfört med placebo, att XEN-D0501 stimulerar kroppens insulinrespons vid ett oralt intag av glukos (socker). Detta var ett bevis för att den här mekanismen för insulinreglering fungerar (proof of principle).

Om diabetes

Diabetes är en global pandemi. Cirka 463 miljoner människor lider av sjukdomen, vilket motsvarar 8-10 procent av jordens befolkning. Uppskattningsvis har 90 procent av alla diabetiker typ 2-diabetes, medan cirka 10 procent har typ 1-diabetes. Sjukdomen kan leda till följdsjukdomar som hjärt-kärlsjukdomar, minska patientens livskvalitet, öka risken för dödsfall samt är mycket kostsam i sjukvårdssystemet. Trots att stora framsteg gjorts med behandling av diabetes återstår ett stort omättat behov av behandlingar som är effektiva, säkra och tillgängliga både fysiskt och i pris. 

Malmö, 20 juli, 2021

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PILA PHARMA AB meddelar att handeln med teckningsoptioner TO 1, under kortnamnet ”PILA TO 1” med ISIN-kod SE0016274005, börjar handlas den 22 juli 2021.

Som tidigare kommunicerats har PILA PHARMA AB (publ) (”PILA PHARMA” eller ”Bolaget”) genomfört en fulltecknad unit-emission av aktier och teckningsoptioner av serie TO 1 (”Teckningsoptionerna”) som tillförde Bolaget en emissionslikvid om 35 MSEK före emissionskostnader i samband med en börsnotering på Nasdaq First North Growth Market.

Handeln med PILA PHARMA:s aktie på Nasdaq First North Growth Market, under kortnamnet ”PILA” med ISIN-kod SE0015988274, påbörjades den 15 juli 2021.

Första dag för handel med Teckningsoptionerna på Nasdaq First North Growth Market är den 22 juli 2021. Teckning av aktier med stöd av teckningsoptioner av serie TO 1 sker under perioden från och med den 23 maj 2022 till och med den 3 juni 2022. 

Varje teckningsoption ger rätt att teckna en (1) ny aktie till en teckningskurs om 10 SEK. Vid fullt utnyttjande av Teckningsoptionerna tillförs Bolaget i juni 2022 en likvid om 39 MSEK.

Rådgivare

Göteborg Corporate Finance (GCF) har varit finansiell rådgivare i samband med emissionen. PILA PHARMA:s Certified Adviser och emmissionsinsitut är Aqurat Fondkommission. MAQS Advokatbyrå är legal rådgivare och auktoriserad revisor är Deloitte.

För mer information:

Dorte X. Gram, CEO
M: +46 (0)73 903 6969
E: dxg@pilapharma.com

Om PILA PHARMA

PILA PHARMA är ett svenskt bioteknik-företag inom diabetesforskning med säte i Malmö. Bolagets mål är att utveckla en överlägsen ny medicin i tablettform mot typ 2-diabetes. Bolaget äger användarpatent för behandling av diabetes och fetma med TRPV1-antagonister samt immateriella rättigheter för utvcekling av  produktkandidaten XEN-D0501.

Om XEN-D0501 och TRPV1-antagonister

XEN-D0501 är en mycket selektiv och potent liten molekyl, en TRPV1-antagonist, som  tidigare utvecklades av Bayer Healthcare och Xention/Ario Pharma.TRPV1-receptorn (även kallad chilireceptorn) har visat sig ha en roll vid smärta och inflammatoriska sjukdomar och tros även spela en roll vid diabetes. PILA PHARMA förvärvade XEN-D0501 i mars 2016 eftersom molekylen i tester visat upp mycket god säkerhet jämfört med andra TRPV1-antagonister i klinisk fas.

TRPV1-antagonister som läkemedelsklass har tidigare förknippats med allvarliga biverkningar som till exempel hypertermi (feber). Den maximala dosen av XEN-D0501 för icke-diabetiska individer har tidigare satts till 4 milligram två gånger dagligen där man noterade god säkerhet men ingen effekt i inte-diabetiska patienter med överaktiv urinblåsa och kronisk hosta. 

I november 2018 kunde PILA PHARMA presentera den första kliniska studien (PP-CT01) där typ 2-diabetespatienter fått XEN-D0501. Studien visade upp god säkerhet upp till 8 milligram vid en enda dos. Det senaste studieresultatet presenterades i september 2020. Studien (PP-CT02) visade att multipla doser av XEN-D0501 (4 mg två gånger dagligen i 28 dagar) också tolererades väl av patienter med typ 2-diabetes. Därutöver visade studien, med statistisk signifikans jämfört med placebo, att XEN-D0501 stimulerar kroppens insulinrespons vid ett oralt intag av glukos (socker). Detta var ett bevis för att den här mekanismen för insulinreglering fungerar (proof of principle).

Om diabetes

Diabetes är en global pandemi. Cirka 463 miljoner människor lider av sjukdomen, vilket motsvarar 8-10 procent av jordens befolkning. Uppskattningsvis har 90 procent av alla diabetiker typ 2-diabetes, medan cirka 10 procent har typ 1-diabetes. Sjukdomen kan leda till följdsjukdomar som hjärt-kärlsjukdomar, minska patientens livskvalitet, öka risken för dödsfall samt är mycket kostsam i sjukvårdssystemet. Trots att stora framsteg gjorts med behandling av diabetes återstår ett stort omättat behov av behandlingar som är effektiva, säkra och tillgängliga både fysiskt och i pris. 

Malmö, 15 juli, 2021

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PILA PHARMA AB meddelar att i dag, den 15 juli 2021, inleds handeln med PILA PHARMA AB:s (“PILA PHARMA” eller “Bolaget”) aktie på Nasdaq First North Growth Market. PILA PHARMA:s aktie handlas under kortnamnet “PILA” med ISIN-kod SE0015988274. Teckningsoptionen handlas under kortnamnet “PILA TO 1” med ISIN-kod SE0016274005, och börjar handlas om cirka en vecka.

Inför noteringen på Nasdaq First North Growth Market genomförde PILA PHARMA en fulltecknad emission av units om en aktie och en teckningsoption som tillförde Bolaget en emissionslikvid om 35 MSEK före emissionskostnader.

Vid en noteringsceremoni i samband med näringslivsveckan i Båstad har VD Dorte X. Gram glädjen att kunna ringa in handeln i PILA PHARMA:s aktie.

“Jag är väldigt glad över att många investerare visat förtroende för vår vision. Den här likviden gör det möjligt för PILA PHARMA att gå vidare mot de fas 2b-studier som är vårt nästa steg i arbetet att ta fram ett effektivt, säkert och prisvärt läkemedel för diabetes typ-2. Jag ser med stor spänning och glädje fram emot den resa vi nu ska göra tillsammans med våra nya aktieägare”, säger VD Dorte X. Gram.

Göteborg Corpoate Finance (GCF) har varit finansiell rådgivare i samband med emissionen. Certified Adviser och emmissionsinsitut är Aqurat Fondkommission. MAQS advokatbyrå är legal rådgivare till PILA PHARMA. Auktoriserad revisor är Deloitte.

För mer information:

Dorte X. Gram, CEO
M: +46 (0)73 903 6969
E: dxg@pilapharma.com

Om PILA PHARMA

PILA PHARMA är ett svenskt bioteknik-företag inom diabetesforskning med säte i Malmö. Bolagets mål är att utveckla en överlägsen ny medicin i tablettform mot typ 2-diabetes. Bolaget äger användarpatent för behandling av diabetes och fetma med TRPV1-antagonister samt immateriella rättigheter för utvcekling av produktkandidaten XEN-D0501.

Om XEN-D0501 och TRPV1-antagonister

XEN-D0501 är en mycket selektiv och potent liten molekyl, en TRPV1-antagonist, som tidigare utvecklades av Bayer Healthcare och Xention/Ario Pharma.TRPV1-receptorn (även kallad chilireceptorn) har visat sig ha en roll vid smärta och inflammatoriska sjukdomar och tros även spela en roll vid diabetes. PILA PHARMA förvärvade XEN-D0501 i mars 2016 eftersom molekylen i tester visat upp mycket god säkerhet jämfört med andra TRPV1-antagonister i klinisk fas.

TRPV1-antagonister som läkemedelsklass har tidigare förknippats med allvarliga biverkningar som till exempel hypertermi (feber). Den maximala dosen av XEN-D0501 för icke-diabetiska individer har tidigare satts till 4 milligram två gånger dagligen där man noterade god säkerhet men ingen effekt i inte-diabetiska patienter med överaktiv urinblåsa och kronisk hosta.

I november 2018 kunde PILA PHARMA presentera den första kliniska studien (PP-CT01) där typ 2-diabetespatienter fått XEN-D0501. Studien visade upp god säkerhet upp till 8 milligram vid en enda dos. Det senaste studieresultatet presenterades i september 2020. Studien (PP-CT02) visade att multipla doser av XEN-D0501 (4 mg två gånger dagligen i 28 dagar) också tolererades väl av patienter med typ 2-diabetes. Därutöver visade studien, med statistisk signifikans jämfört med placebo, att XEN-D0501 stimulerar kroppens insulinrespons vid ett oralt intag av glukos (socker). Detta var ett bevis för att den här mekanismen för insulinreglering fungerar (proof of principle).

Om diabetes

Diabetes är en global pandemi. Cirka 463 miljoner människor lider av sjukdomen, vilket motsvarar 8-10 procent av jordens befolkning. Uppskattningsvis har 90 procent av alla diabetiker typ 2-diabetes, medan cirka 10 procent har typ 1-diabetes. Sjukdomen kan leda till följdsjukdomar som hjärt-kärlsjukdomar, minska patientens livskvalitet, öka risken för dödsfall samt är mycket kostsam i sjukvårdssystemet. Trots att stora framsteg gjorts med behandling av diabetes återstår ett stort omättat behov av behandlingar som är effektiva, säkra och tillgängliga både fysiskt och i pris.

Malmö, Sweden, May 21, 2021

Download the press release as PDF here

“I am pleased to share the information that we have promoted Lars Bukhave Rasmussen, to become Chief Operating Officer (COO).  Further, I’m proud to announce the appointment of Elna Lembrér Åström, to new Chief Financial Officer (CFO)”, says CEO Dorte X. Gram. 

Lars Bukhave Rasmussen joined PILA PHARMA in September 2020 as the company’s first CFO and has contributed significantly to the company’s proposed stock market listing.  

“We are now in the phase of preparing the organisation for the increased demands for listed companies. My new main focus as COO will be to establish a scalable organizational model that can deliver results in an effective manner, which is where my main professional competetences reside. This new model includes increasing the number of employees and will ensure that we will be able to handle even larger and more complex activities going forward”, says new COO Lars Bukhave Rasmussen. 

Elna Lembrér Åström takes over the important position as PILA PHARMAs CFO and has previously served as PILA PHARMAs accountant between 2016-2019.  She holds a Bachelor of Science in Business and Economics and is a Swedish Certified Public Accountant. She has extensive experience with financial reporting for listed companies, including the life science companies Saniona, RhoVac, Lundbeck (Sweden), as well as Atos Medical, Biomet Scientific, Ferring, Ferrosan and Mediplast.  

“I’m really pleased to be back working with CEO Dorte X. Gram and PILA PHARMA. It is truly inspiring how Dorte has managed to mature the company to this level and I look forward join the continued growth journey of PILA PHARMA as part of the management team”, says new CFO Elna Lembrér Åström. 

“Throughout the last couple of months we have noticed strong investor interest in PILA PHARMA and I feel we will now stand stronger for potentially listing PILA PHARMA later this year at Nasdaq First North Growth Market in Stockholm.”, says CEO Dorte X. Gram.  

For further information, please contact:

Dorte X. Gram, CEO

M: +46 (0)73 903 6969
E: dxg@pilapharma.com

About PILA PHARMA

PILA PHARMA is a Swedish biotech company in the diabetes segment based in Malmö. The aim of the company is to develop a novel and superior tablet based treatment for type 2 diabetes. The company owns both use patents for treating diabetes and obesity with TRPV1 antagonists, and the intellectual property rights for the mid stage clinical development candidate XEN-D0501.

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a highly selective and very potent small molecule TRPV1 antagonist, previously in development by Bayer Healthcare and Xention/Ario Pharma. The TRPV1 target (also called the “chili-receptor”) has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes as well. XEN-D0501 was acquired by PILA PHARMA in March 2016, due to its very good safety and tolerability as compared to other clinical TRPV1-antagonist development candidates. TRPV1 antagonists as a drug-class has previously been associated with severe adverse events as fever (hyperthermia). The maximal tolerable dose in non-diabetic individuals has previously been determined to be 4 milligrams twice daily, a dose level with good safety but no effect in non-diabetic patients with either overactive bladder disease or chronic cough. In November 2018, PILA PHARMA reported the completion of its first clinical trial, PP-CT01, demonstrating good safety of XEN-D0501 at single doses up to 8 milligrams when administered to people with type 2 diabetes. The most recent study results were announced in September 2020. The study (PP-CT02) demonstrated that multiple doses of XEN-D0501 (4 mg twice daily for 28 days) were likewise safe and welltolerated by people with type 2 diabetes and also – with statistical significance versus placebo – that XEN-D0501 enhances the endogenous insulin response to oral glucose, thus demonstrating proof of principle.

About diabetes

Diabetes is a world-wide pandemic with a staggering prevalence of 463 million diabetics corresponding to approximately 8-10% of the population. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes. The disease can lead to cardiovascular disease resulting in reduction of quality of life for the patient, increased risk of death and high health care expenses. Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, adherence, accessibility and affordability perspective.

Malmö, Sweden, 10 March 2021

Download the press release as PDF here

PILA PHARMA AB, a Swedish biotech company, today, announces the successful completion of a recent new shares issue (Pre-IPO). 

“I am very happy to share the information that we have successfully raised the 15 MSEK that we set out to do and previously communicated we would”, says CEO Dorte X. Gram. 

Besides supplying the company with funds for continued operational activities in parallel to preparations for the upcoming IPO later this year, the Pre-IPO has also expanded the investor base further.  

New shareholder in PILA PHARMA and former CFO at Saniona, Thomas Feldthus, explains why he chose to invest at this stage: “From my perspective, PILA PHARMA has managed to reach mid-stage clinical development with a potentially first in class product based on a novel and promising mode of action which is highly unique. Further I have great confidence in the Founder & CEO who have managed to bring the product candidate this far through prudent use of resources”.  

In addition to the Pre-IPO investments made, also a base of pre-subscription of shares at the IPO has been secured, setting the stage for a successful IPO.  

“We have noticed a great investment interest which is really sparking our enthusiasm about the IPO and we truly look forward to listing PILA PHARMA later this year at Nasdaq First North Growth Market in Stockholm.”, says CFO Lars B. Rasmussen.

For further information, please contact:

Dorte X. Gram
Chairman of the Board

M: +46 (0)73 903 6969
E: dxg@pilapharma.com

About PILA PHARMA

PILA PHARMA is a Swedish biotech company in the diabetes segment based in Malmö. The aim of the company is to develop a novel and superior tablet based treatment for type 2 diabetes. The company owns both use patents for treating diabetes and obesity with TRPV1 antagonists, and the intellectual property rights for the mid stage clinical development candidate XEN-D0501. 

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a highly selective and very potent small molecule TRPV1 antagonist, previously in development by Bayer Healthcare and Xention/ Ario Pharma. The TRPV1 target (also called the “chili-receptor”) has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes as well. XEN-D0501 was acquired by PILA PHARMA in March 2016, due to its very good safety and tolerability as compared to other clinical TRPV1-antagonist development candidates. TRPV1 antagonists as a drug-class has previously been associated with severe adverse events as fever (hyperthermia). The maximal tolerable dose in non-diabetic individuals has previously been determined to be 4 milligrams twice daily, a dose level with good safety but no effect in non-diabetic patients with either overactive bladder disease or chronic cough. In November 2018, PILA PHARMA reported the completion of its first clinical trial, PP-CT01, demonstrating good safety of XEN-D0501 at single doses up to 8 milligrams when administered to people with type 2 diabetes. The most recent study results were announced in September 2020. The study (PP-CT02) demonstrated that multiple doses of XEN-D0501 (4 mg twice daily for 28 days) were likewise safe and welltolerated by people with type 2 diabetes and also – with statistical significance versus placebo – that XEN-D0501 enhances the endogenous insulin response to oral glucose, thus demonstrating proof of principle. 

About diabetes

Diabetes is a world-wide pandemic with a staggering prevalence of 463 million diabetics corresponding to approximately 8-10% of the population. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes. The disease can lead to cardiovascular disease resulting in reduction of quality of life for the patient, increased risk of death and high health care expenses. Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, adherence, accessibility and affordability perspective. 

Malmö, Sweden, 17h November 2020

Download the press release as PDF here

PILA PHARMA AB, a Swedish biotech company, is pleased to announce the decision to list the company.

The Initial Public Offering (IPO), aiming for listing of the company’s shares on one of the unregulated stock exchanges in Sweden, is targeted for Q2-2021.
To facilitate the IPO process, Göteborg Corporate Finance (GCF) has been selected as the capital finance partner.

“I am thrilled that we have finally made the decision to list PILA PHARMA” says Dorte X. Gram, founder and Chairman of the Board. “This will give us a solid platform to continue the development of XEN-D0501 as a new type of diabetes medication”.

“The cost of developing new drugs increases significantly around phase 2, so listing PILA PHARMA at this point in time is a natural step towards successful financing expresses CFO Lars B. Rasmussen. “I am very pleased with the selection of GCF as our capital finance partner for the IPO process and at the same time highly confident that GCF’s investor network reach, and their IPO experience will complement our pharma competences very well to make a successful case”.

Tyge Korsgaard, Director of the Board completes: “I have previously participated in the listing of two Danish biotech companies Genmab A/S (current market cap of approx. SEK 210 billion) and Zealand Pharma A/S (current market cap of approx. SEK 13 billion). Now it is PILA PHARMA’s turn. I really look forward to participate in the listing of PILA PHARMA, which I find has great untapped potential”.

For further information, please contact:

Dorte X. Gram
Chairman of the Board

M: +46 (0)73 903 6969
E: dxg@pilapharma.com

About PILA PHARMA

PILA PHARMA is a Swedish biotech company in the diabetes segment based in Malmö. The aim of the company is to develop a novel and superior tablet based treatment for type 2 diabetes. The company owns both use patents for treating diabetes and obesity with TRPV1 antagonists, and the intellectual property rights for the mid stage clinical development candidate XEN-D0501.

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a highly selective and very potent small molecule TRPV1 antagonist, previously in development by Bayer Healthcare and Xention/ Ario Pharma. The TRPV1 target (also called the “chili-receptor”) has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes as well. XEN-D0501 was acquired by PILA PHARMA in March 2016, due to its very good safety and tolerability as compared to other clinical TRPV1-antagonist development candidates. TRPV1 antagonists as a drug-class has previously been associated with severe adverse events as fever (hyperthermia). XEN-D0501 has in healthy volunteers been shown to induce a modest temperature increase following the first dose, that fades out during the first 2 weeks of dosing. The maximal tolerable dose in non-diabetic individuals has previously been determined to be 4 milligrams twice daily, a dose level with good safety but no effect in non-diabetic patients with either overactive bladder disease or chronic cough. In November 2018, PILA PHARMA reported the completion of its first clinical trial, PP-CT01, demonstrating good safety of XEN-D0501 at single doses up to 8 milligrams when administered to people with type 2 diabetes. The most recent study results were announced in September 2020. The study (PP-CT02) demonstrated that multiple doses of XEN-D0501 (4 mg twice daily for 28 days) were likewise safe and well-tolerated by people with type 2 diabetes and also – with statistical significance versus placebo – that XEN-D0501 enhances the endogenous insulin response to oral glucose, thus demonstrating proof of principle.

About diabetes

Diabetes is a world-wide pandemic with a staggering prevalence of 463 million diabetics corresponding to approximately 8-10% of the population. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes. The disease can lead to cardiovascular disease resulting in reduction of quality of life for the patient, increased risk of death and high health care expenses. Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, adherence, accessibility and affordability perspective.

Malmö, Sweden, 24th September 2020

You can also download the press release as PDF here

PILA PHARMA AB, a Swedish biopharma company, is pleased to announce that its phase 2a trial, PP-CT02, designed to investigate the efficacy and safety following 28 days dosing of XEN-D0501 4 milligrams twice daily as compared to placebo in patients with type 2 diabetes, has been successfully completed.

No serious adverse events were observed in PP-CT02, and only few and mild to moderate (expected) adverse events were recorded.
Further, the patients receiving XEN-D0501 with statistical significance demonstrated an enhanced insulin response to an oral glucose tolerance test conducted on day 28.

“I’m very pleased to see, that also after a prolonged dosing period, XEN-D0501 proved to be safe in people with type 2 diabetes” says Dorte X. Gram, Chairman of the Board. “Further, the profound effect on insulin is remarkable in at least two ways. Firstly, it is the first time that a positive effect has been recorded for XEN-D0501 in type 2 diabetes patients, demonstrating it to be a highly promising safe and effective drug candidate. Secondly, it proves that our working hypothesis is true – that TRPV1 antagonists, e.g. XEN-D0501, exerts part of its anti-diabetic action via stimulation of endogenous insulin release. As an inventor of this principle, these results of course, makes me truly proud”.

With these clinical trial outcomes, PILA PHARMA remains highly confident in continuing the development of XEN-D0501 as a potential novel anti-diabetic agent and strengthens the Scientific Advisory Board with Dr. Mark Evans, UK, a well reputed clinical researcher in diabetes with a special interest in the effects of insulin in diabetes.

Further, the strong pharma-capacity, Lars Bukhave Rasmussen, will join the management team in becoming the first Chief Financial Officer in PILA PHARMA.

Lars B. Rasmussen brings significant business experience within the full pharma value chain to PILA PHARMA obtained primarily through his previous positions at LEO Pharma A/S, a global mid-size biopharma company headquartered in Denmark.

“I am extremely proud and excited to join PILA PHARMA at this crucial point in time for XEN-D0501. Having prior hands-on research experience with the “un-drugable” TRPV1 receptor, I am very convinced by the clinical XEN-D0501 data I have seen. PILA Pharma could very well have found the key to truly unlock clinically effective and safe TRPV1 targeted treatments. In essence, the company now has the potential to effectively address the high and growing unmet needs of type 2 diabetes patients through a novel mode of action, as well as address other diseases with high unmet needs where TRPV1 may also play a role“, says Lars B. Rasmussen.

Chairman of the Board, Dorte X. Gram, completes: “Fifteen years ago, Lars did his DVM master-thesis on TRPV1 in diabetes with me as supervisor. Since then, I have followed his impressive career with great interest. Needless to say, I am more than pleased with having Lars back and he will be instrumental in maximizing the value of PILA PHARMAs core assets both from a scientific, market and financial perspective going forward”.

For further information, please contact:

Dorte X. Gram
Chairman of the Board

M: +46 (0)73 903 6969
E: dxg@pilapharma.com

About PILA PHARMA

PILA PHARMA is a Swedish pharmaceutical company in the diabetes segment based in Malmö. The aim of the company is to develop a novel and superior tablet based treatment for type 2 diabetes. The company owns both use patents for treating diabetes and obesity with TRPV1 antagonists, and the intellectual property rights for the mid stage clinical development candidate XEN-D0501.

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a highly selective and very potent small molecule TRPV1 antagonist, previously in development by Bayer Healthcare and Xention/ Ario Pharma. The TRPV1 target (also called the “chili-receptor”) has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes as well. XEN-D0501 was acquired by PILA PHARMA in March 2016, due to its very good safety and tolerability as compared to other clinical TRPV1-antagonist development candidates. TRPV1 antagonists as a drug-class has previously been associated with severe adverse events as fever (hyperthermia). XEN-D0501 has in healthy volunteers been shown to induce a modest temperature increase following the first dose, that fades out during the first 2 weeks of dosing. The maximal tolerable dose in non-diabetic individuals has previously been determined to be 4 milligrams twice daily, a dose level with good safety but no effect in non-diabetic patients with either overactive bladder disease or chronic cough. In November 2018, PILA PHARMA reported the completion of its first clinical trial, PP-CT01, demonstrating good safety of XEN-D0501 at single doses up to 8 milligrams when administered to people with type 2 diabetes.

About diabetes

Diabetes is a world-wide pandemic with a staggering prevalence of 463 million diabetics corresponding to approximately 8-10% of the population. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes. The disease can lead to cardiovascular disease resulting in reduction of quality of life for the patient, increased risk of death and high health care expenses. Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, adherence, accessibility and affordability perspective.