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Malmö, 26 November 2023

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Pila Pharma AB (publ) (“Pila Pharma” or the “Company”) has entered a research collaboration with the Research Group of Professor Dick Wågsäter, Uppsala University, Sweden (the “Research Group”) on investigating the effect of XEN-D0501 on Abdominal Aorta Aneurism growth in mice.

The hypothesis is that XEN-D0501 may reduce the chronic inflammation that leads to cardiovascular disease including aorta dilatation. Thus, XEN-D0501 could potentially prevent the lethal end-stage development of Abdominal Aorta Aneurism.

This collaboration will cover a small study in mice that the Research Group will sponsor whilst Pila Pharma sponsors XEN-D0501. The results will be split in that the Research Group gets the publication right (after patenting) and Dick Wågsäter has agreed to transfer to Pila Pharma the patent rights against that Pila Pharma sponsors any resulting patents.

The aim of this new collaboration is to establish a pre-clinical proof-of-concept of an effect of XEN-D0501 on preventing progression of Abdominal Aorta Dilatation in mice.

Professor Dick Wågsäter comments:
One of my professional goals is to search for a suitable treatment of Abdominal Aorta Aneurism!  It is a deadly cardiovascular disease that accounts for 1% of deaths in men over 65 years of age and where no drugs are currently available for prevention or treatment.
So, I’m really pleased that this collaboration with Pila Pharma can finally start. 
If the results of this mouse study will be positive, further clinical development plans for the assessment of XEN-D0501 in humans with Abdominal Aorta Aneurism have already been discussed to further pave the way for XEN-D0501 as the missing preventive treatment. 

CEO Dorte X. Gram comments:                                                       
We’re currently developing XEN-D0501 as an affordable treatment of diabetes and obesity with multiple beneficial effects including the reduction of cardiovascular disease risk.
Our own clinical results on the latter will not be available for long, so I welcome this mouse study as it might provide data on a cardiovascular function effect of XEN-D0501. 

More-over, I have recently experienced the disease of Abdominal Aorta Aneurism in my close family, and I know how frustrating it is to know that stent surgery is the only option for short term survival. In my part of the world, such surgery is available but not without risks. In other parts of the world, it’s not available due to high cost. 
Therefore, contributing to an affordable prevention also of this serious disease has become a personal motivation to me. Hopefully it can save more lives and further increase wellbeing and longevity in man.

For more information:

Dorte X. Gram, CEO                                                                                             
Text: +46 (0)73 903 6969                                                                

This information is such information that PILA PHARMA AB is obliged to publish in accordance with the EU Market Abuse Regulation. The information was submitted for publication on 26 November 2023 at 21:45 CET.

Pila Pharma’s share ticker PILA is subject to trade on Nasdaq First North Growth Market, Sweden with Aqurat Fondkommission AB as Certified Adviser.
Contact: M: – T: +46 (0)8 684 05 800

About PILA PHARMA AB (publ)

Pila Pharma is a Swedish biotech company based in Malmö, Sweden. The aim of the Company is to develop TRPV1 antagonists as novel treatments of e.g. type 2 diabetes or of the painful rare disease erythromelalgia. 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 as well as back-up candidates. The FDA in USA in July 2022 granted Orphan Drug Designation for XEN-D0501 as treatment of erythromelalgia. The Company was listed at Nasdaq First North GM in Stockholm, Sweden in July 2021.

About XEN-D0501 and TRPV1 antagonists

XEN-D0501 is a selective, synthetic potent small molecule TRPV1 antagonist that was inlicensed in 2016 and, previously, developed by Bayer Healthcare, Germany and Xention/ Ario Pharma, UK. The TRPV1 target (also called the “chili-receptor”) and TRPV1 antagonists that down-regulate neurogenic inflammation, has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes as well. Prior to in-licensing, XEN-D0501 had been found to have a good safety profile in other (non-diabetic) patient groups. Pila Pharma has to date completed two phase 2a clinical trials (PP-CT01 and PPCT02), that both demonstrated that XEN-D0501 is well tolerated by type 2 diabetic patients. Further, PP-CT02, demonstrated that XEN-D0501 (administered as 4 mg BID for 28 days) – with statistical significance versus placebo – enhance the endogenous insulin response to oral glucose. Final results from recently completed preclinical 13-week safety studies show that XEN-D0501 is well tolerated in both “rodents” and “non-rodents” and the molecule can thus advance to clinical studies of up to 3 months duration.

About Diabetes and Obesity

Diabetes is a world-wide pandemic with a staggering prevalence of 537 million people with diabetes 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.

Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, affordability, and accessibility exists for treatment of people with type 2 diabetes. Obesity is most often preceding the development of type 2 diabetes and a serious risk-factor for not only developing type 2 diabetes but also all the co-morbidities resulting in “whole body dysfunction” and subsequent development of several diseased. The accumulated effect is a year-long reduction in of quality of life for obese persons with or without diabetes. Obesity leads to an increased risk of developing cardiovascular disease that eventually results in premature death and shortening of life duration. Recent advances by “Big Pharma” in the development of effective anti-obesity drugs, has proven that pharmacological weight management is possible and leads to obvious quality-of-life and longevity benefits for people with obesity. Even long-term public health costs are expected to be reduced if the clinical negative effects of the obesity pandemic can be limited. This has sparked a general interest in future potential oral treatments that can meet the accessibility/ affordability criteria and several deals have recently been done in the obesity segment.

About Erythromelalgia

Erythromelalgia is a rare disease where neurogenic inflammation plays a role in the development of symptoms. The disease can cause near-constant or episodic pain (ranging from mild tingling to severe burning sensations), and redness to extremities. It most commonly affects the feet but may also occur in the hands, face, or other parts of the body with both nerves and blood vessels involved. Symptoms are frequently managed through avoidance of pain triggers. The disorder can be extremely debilitating, with a significant negative impact on quality of life and with potential to impact mortality rates among young people and the suicide rates among adults.

About Abdominal Aorta Aneurism

Abdominal Aorta Aneurism is a cardiovascular disease with ‘balooning’ of the lower part of the main artery of the body, aorta. The cause is unknown, but risk factors are atherosclerosis, high blood pressure, cardiovascular inflammation and infection as well as trauma. It affects millions of people globally and accounts for the death of 1% of men over the age of 65. It develops gradually over several years up to a dilatation of more than 3mm in diameter when surgery to insert a stent to prevent rupture is then the only treatment option, both expensive and with complications. Currently no preventive treatment is available.

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