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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.

Malmö, Sweden, 7th November 2018

You can also download the press release as PDF here

PILA PHARMA announces good safety of XEN-D0501 following single doses in patients with type 2 diabetes

PILA PHARMA AB, a pharmaceutical company based in Malmö, Sweden, is pleased to announce that on November 1st, 2018, the dosing of patients in its first trial PP-CT01, studying the safety and tolerability of XEN-D0501 in patients with type 2 diabetes, was completed.

XEN-D0501 is a highly selective and very potent 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 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 was previously been determined to be 4 mg BID.

In PP-CT01, the doses to be studied were 1, 2 and 4 mg but during the conduct of trial, regulatory approval was obtained to increase to a higher maximal level of 8 mg due to better than expected safety of the lower doses.

No serious adverse events were observed in PP-CT01, and only few and mild (expected) adverse events were recorded.
Importantly, no hypo-glycemic events nor episodes of hyperthermia were observed.

“I’m very pleased to see, that we did not see any hyperthermia or other severe problems in the diabetic patients” says CEO Dorte X. Gram.
The finding that no patients experienced hyperthermia and that XEN-D0501 appear to be safe following a single dose to type 2 diabetic patients is really good news”.

The recruitment of patients for PP-CT01 took a lot longer than expected, so in order to not stand still, PILA PHARMA earlier this year applied for the approval to conduct the next pilot phase 2 trial, PP-CT02.

In August, PILA PHARMA received the great news of regulatory approval of PP-CT02 and now works intensively to initiate this pilot phase 2 trial to investigate the efficacy and safety following 28 days dosing of XEN-D0501 BID as compared to placebo in patients with type 2 diabetes.

“It is a tremendous leap forward and could potentially be the steps towards proof-of-concept study in man, that I have been aiming at since the establishment of PILA PHARMA”, says Dorte X. Gram, founder and CEO of PILA PHARMA.

For further information, please contact:

Dorte X. Gram
CEO and Director 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 diabetes. The company owns use patents for treating diabetes and obesity with TRPV1 antagonists and a clinical ready and safe TRPV1 development candidate XEN-D0501.

About diabetes

Diabetes is a world-wide pandemic with a staggering prevalence of 422 m diabetics corresponding to approximately 8-10% of the population. 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. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes.

Malmö, Sweden, 6th December 2017

You can also download the press release as PDF here

PILA PHARMA passes the start-up phase, prepares for efficacy trials and increases focus on ‘Effective and Affordable Medicine’ by electing the health economist Ulrikka Klarskov Kjær to the Board of Directors

PILA PHARMA, founded in 2014, now counts +10 core members and has thus passed the “start-up” phase. “We are about to move out of the Medeon Incubator in Malmö and have also established a Danish affiliate to handle the R&D activities in Denmark”, says Dorte X. Gram, CEO of PILA PHARMA.

Given the fact that PILA PHARMA has established itself as a young, but serious player in the diabetes field and that the company has been able to recruit an extremely competent staff to develop the company,
Per Antonsson from Almi Invest has decided to step down from the Board of Directors in order to focus on new start-up projects in Almi’s portfolio.

Per Antonsson says: “I was one of the very first to see the potential in PILA PHARMA and we were the first external investor to join almost 3 years ago. I have been delighted to be actively involved in the company’s lift-off as well as being a member of the Board of Directors. The company has now grown to a size and maturity where I consider it to be stable enough for me to scale down my day-to-day engagement. I would like to thank Dorte for her commitment and strong will to succeed, and, as the second-largest investor in the company, I will follow the company from the outside with continued interest.”

Dorte X. Gram, CEO of PILA PHARMA states: “We have been privileged to have had access to Per’s experience and network. Per has played a crucial role in the company’s start-up phase shaping the company to allow for future growth. We consider his wish to step down from the Board, to be a statement of his positive thoughts on PILA PHARMA.”

Erik Nerpin, Chairman of the Board, continues: “Per has been a very engaged member of the Board, and we will miss his contributions to the strategic decisions we make. In the search to find a suitable replacement to Per, it has been important to add new skills, and we have analysed the forthcoming challenges and opportunities for PILA PHARMA. The Board of Directors has identified positioning of XEN-D0501 as a better and cheaper drug-choice as very important. We therefore look forward to welcoming Ulrikka Klarskov Kjær and her unique competences within international health economics to the Board of Directors.”

Ulrikka Klarskov Kjær supplements: “The world, and in particular developing regions like Africa, need access to effective and affordable treatments of diabetes to tackle the healthrelated and economic consequences of the disease. Therefore, I’m delighted to join PILA PHARMA to help elucidating the potential health economic benefits of XEN-D0501 in treating diabetes and potentially obesity in the future.

Ulrikka holds a double degree with an MSc in Health Economics as well as an MA in African Studies and has worked on multiple international projects. In addition, she has extensive specialist and managerial experience from Danish appointments at Novo Nordisk, Rambøll and Ledøje-Smørum Municipality, the latter as Director of Health and Social Affairs.

For further information, please visit: PILA PHARMA Board of Directors.

Notes to Editors:

Contact:

PILA PHARMA
Dorte X. Gram, CEO

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

About PILA PHARMA

PILA PHARMA is a privately held clinical stage pharmaceutical company based in Malmö, Sweden that is developing XEN-D0501, a TRPV1 antagonist, as an effective and affordable treatment of diabetes and associated obesity.

For further information, please visit: pilapharma.com

About diabetes

Diabetes is a worldwide pandemic with a staggering prevalence of more than 425 m diabetics corresponding to approximately 8-10% of the population.
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. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes.

Malmö, Sweden, 9th  May 2017

You can also download the press release as PDF here

PILA PHARMA has carried out a fully subscribed new issue of shares

PILA PHARMA AB, a Swedish pharmaceutical company based in Malmö, is pleased to announce that the company has raised SEK 10 million through a fully subscribed new issue shares.

Both existing shareholders and new investors participated in the new issue. ALMI Invest for the third time defended its position of 15 per cent of the share capital and remains the second largest shareholder in the company behind Dorte X. Gram, the founder and CEO of PILA PHARMA.

PILA PHARMA is developing a novel type of oral anti-diabetic agent: a TRPV1 antagonist for the treatment of diabetes. PILA PHARMA recently received regulatory approval of its first clinical trial application, permitting the company to move its clinical development candidate XEN-D0501 into a safety trial in type 2 diabetic patients. Recruitment of patients to the safety trial is ongoing.

In addition to the safety trial, the proceeds from the new issue will also enable PILA PHARMA to further consolidate it’s internal organisation, to plan for the next clinical efficacy trial and to – earlier than originally planned – initiate internal research activities with the aim of strengthening the company’s IP-portfolio, carry out further asset exploration and to evaluate new licensing opportunities.

Dorte X. Gram, the inventor of the principle of treating diabetes with TRPV1 antagonists and with a background including more than ten years at Novo Nordisk A/S in Denmark, comments: “I am very pleased with the strong interest from both existing shareholders and new investors and particularly that PILA PHARMA now has a strong international shareholder base. My organisation and I are really motivated to enter the next phase in PILA PHARMA’s development where we seem to be on the map of both investors and potential exitpartners as well as of other companies with assets that may complement ours”.

“It is amazing how far Dorte X. Gram has brought PILA PHARMA in less than three years and with limited funds from previous financing rounds. So even if SEK 10 million may look like a small amount in the biotech industry, this financing secures that PILA PHARMA can continue its rapid development”, says Erik Nerpin, Chairman of the Board.

Notes to Editors:

Contact:

PILA PHARMA
Dorte X. Gram, PhD
CEO

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

About PILA PHARMA

PILA PHARMA is a privately held clinical stage pharmaceutical company based in Malmö, Sweden.
PILA PHARMA is developing a novel type of oral anti-diabetic agent: a TRPV1 antagonist for the treatment of diabetes.
XEN-D0501, the recently purchased, safe clinical development candidate, is entering the first clinical trial in type-2 diabetic patients in 2017.

For further information, please visit: pilapharma.com

About diabetes

Diabetes is a world wide pandemic with a staggering prevalence of 422 m diabetics corresponding to approximately 8-10% of the population.
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. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes.

Malmö, Sweden, 6th  March 2017

You can also download the press release as PDF here

PILA PHARMA receives regulatory approval of its first clinical trial application and appoints new Chairman of the Board

PILA PHARMA AB, a Swedish pharmaceutical company based in Malmö, Sweden, is pleased to announce that it has received regulatory approval of its first clinical trial application thus permitting the company to move its clinical development candidate, XEN-D0501, into a safety trial in type 2 diabetic patients.

“I am very excited about finally being at the point where we can progress a TRPV1 antagonist into diabetic patients!”, says Dorte X. Gram, founder and CEO of PILA PHARMA and continues: “It is nearly 17 years since I formulated the hypothesis that inhibitors of the TRPV1 (a.k.a. the “chili-receptor”) could be novel pharmacologic tools for the treatment of obesity and obesity-related diseases and disorders. Today, PILA PHARMA has use-patents that give us the exclusive right to treat obesity and diabetes with TRPV1 receptor antagonists and we are now very close to test the first development candidate, XEN-D0501, in diabetic patients.”

The first step will be to assess the safety of the molecule following a single-dose in diabetic patients. If successful, it can progress to multiple-dose efficacy trials to test the effect in diabetics later this year.

In 2003, Dorte X. Gram defended the hypothesis in her PhD thesis “Capsaicin-Sensitive Nerves in Experimental Diabetes” to a dream-team of opponents: professors Henning Beck-Nielsen, Jens Juul Holst and Mads Krogsgaard Thomsen.

During the last year PILA PHARMA has been working closely together with professor Henning Beck-Nielsen’s clinical team at Odense University Hospital in Denmark, to prepare for the clinical trial.

“Henning was the first to suggest that we should test the concept in man, but no clinical-ready TRPV1 antagonists were available at that time. Henning is one of the academic “heavyweights” in diabetes, so I am extremely grateful that Henning still supported the project, when I called to ask for his help more than 10 years later, when antagonists were potentially available”, says Dorte X. Gram.

With Henning Beck-Nielsen back in the project, the plan for moving rapidly towards clinical proof of concept with a clinical ready substance was created and a pilot phase 2 protocol was suggested by Henning Beck-Nielsen.

“We still follow that plan, but due to regulatory requirements, a single-dose safety study was inserted in the plan and is now being initiated. As soon as possible, thereafter, we will conduct the pilot phase 2 originally designed by Henning”, says Dorte X. Gram.

Given PILA PHARMA’s rapid development and predicted future increase in capital need, PILA PHARMA has appointed attorney Erik Nerpin as new Chairman of the Board. He has 25 years of experience in corporate finance and M&A, including high profile transactions such as Pfizer’s acquisition of Pharmacia, where he advised Pfizer. For many years, he has been advisor to the Lundin Group of companies, including Lundin Petroleum and Lundin Mining. He has also long experience of board work in pharmaceutical companies, being currently Chairman of Kancera and Diamyd Medical, both listed on Nasdaq First North in Stockholm, Sweden.

“Over the years, I have advised numerous early stage pharmaceutical companies. Many of them have, as expected in this business, failed but some of them have actually made it, such as Alligator Bioscience, CellaVision and Hansa Medical, today all successful companies listed on Nasdaq in Stockholm, Sweden. It is an honor for me to enter the board as new Chairman and I am convinced that PILA PHAMA will grow into something really big in the near future”, comments Erik Nerpin.

“I am extremely impressed by Dorte X. Gram as founder and CEO”, comments Erik Nerpin further. Being a football fan, he adds “I believe everybody who knows football will understand when I call Dorte X. Gram “The Special One”.

Dorte X. Gram adds: “Erik is super sharp and I believe that he will add real value to me, our Board and the company. I am very, very proud that he has accepted to work with me as Chairman and closest colleague in PILA PHARMA”.

For further information, please contact:

Dorte X. Gram
CEO and Director of the Board

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

Erik Nerpin
Chairman of the Board

M: +46 (0)70 620 7359
E: erik.nerpin@advokatnerpin.com

Please also visit PILA PHARMA’s webb page: 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 diabetes. The company owns use patents for treating diabetes and obesity with TRPV1 antagonists and a clinical ready and safe TRPV1 development candidate XEN-D0501.

About diabetes

Diabetes is a world-wide pandemic with a staggering prevalence of 422 m diabetics corresponding to approximately 8-10% of the population. 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. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes.

In 2014, the global diabetes market was assessed to be 37,5 bn € and is projected to rise to >100 bn € in 2018. Approximately half of this market attributes to oral anti-diabetic agents (tablets) whereas the other half of the market attributes to injectable treatments, like insulin and GLP-1.