PILA PHARMA HAS BEEN SELECTED TO PARTICIPATE IN THE REGIONAL SCALE-UP PROGRAM “10 X HEALTH”

Malmö, 16 January 2024

Pila Pharma and its CEO, Dorte X. Gram, has been selected to participate cost-free in a scale-up program “10 X Health” partially sponsored by the European Regional Development Fund and organised by the SmiLe Incubator and Medicon Village in Lund, Sweden.

Medicon Village and the SmiLe Incubator in Southern Sweden have – with the support of the European Regional Development Fund – initiated a scale-up program (“10 X Health”) for established, smaller life science companies to help accelerate their growth.

“We’re strategically working on supporting the life-science sector in our region to support future regional economic growth. The new “10 X Health” is completely focused on our regional life science companies that have successfully passed the start-up phases and the hope is to consolidate their skills required for them to accelerate their growth further“, says Ulrika Ringdahl, Deputy CEO of Smile Incubator

The program extends over 11 months and will cover several key topics for growth: 1) Self-assessment for scale-up, 2) Strategy, 3) People, 4) Market, 5) Digitalisation and new technologies, 6) Capital and finance, 7) Sustainability, 8) Regulatory Acceleration and 9) Ready to grow 10 X more.

CEO Dorte X. Gram comments: “I’m pleased, that Pila Pharma has been selected to be one out of seven regional life-science companies to enjoy this financial and regional support of the “10 x Health” program and the timing is really perfect. We’re currently heading towards the last small clinical trial with XEN-D0501 in obese persons with diabetes, before we will enter a phase with bigger clinical studies with a need to scale-up our business”.

Malmö, 16 January 2024

For more information:

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

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: ca@aqurat.se – 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.

About “10 X Health”

The scale-up program “10 X Health” is a new program initiated by Medicon Village and SmiLe Incubator in Lund, Sweden. Seven life science companies have been selected to participate with the aim of strengthen the skills of these established companies to accelerate their growth. In the scale-up phase, there are many challenges and the program is adapted to specific needs in this phase, which include business acumen, financing, technology, internationalization, organization and effective leadership. The program is part-financed over three years by the European Regional Development Fund.