Following the summer's highly oversubscribed rights issue (293,5%) of units, which the company described as a "bet on obesity", Pila Pharma is now moving from words to action. On Friday, the company announced that the planned preclinical studies with the candidate XEN-D0501 have commenced.
The aim is to deliver proof-of-concept—evidence that the TRPV1 inhibitor XEN-D0501 induces effect on body weight. The results from these studies will play part in the company's partnering strategy and determine the next steps for clinical studies within the indications of obesity and overweight.
Testing in two models at Gubra
The studies are being conducted in collaboration with the Danish contract research organisation Gubra, which specialises in metabolic diseases. The tests are performed on two different types of rat models to provide as comprehensive a picture as possible:
- • DIO rats (Diet-Induced Obesity): Normal rats that have developed obesity through a high-fat diet.
- • Zucker rats: Rats with a genetic mutation that causes them to spontaneously overeat and develop obesity even on a normal diet.
Expert guidance on board
To ensure the best possible scientific foundation for its obesity program, Pila Pharma has also recently strengthened its team. The company recently had Professor Thomas Lutz, a renowned expert in metabolic research and the pancreatic hormone amylin, join its Scientific Advisory Board.
Professor Lutz's deep understanding of the pathophysiology of obesity and related comorbidities, such as type 2 diabetes, will be invaluable as Pila Pharma navigates the complex landscape of metabolic drug development. You can read more about Professor Lutz and his perspective on the obesity market in our recent interview here.
Targeting massive market with a scalable pill option
The stakes are high. The obesity market is one of the pharmaceutical industry's fastest-growing sectors. By 2030, it is projected to reach USD 100 billion per year in sales and serve 2 billion people. Injectable GLP-1 agonists are currently dominating, yet many patients still cannot access these options, and Pila Pharma sees a chance to fill this gap with a safe, scalable alternative.
By inhibiting the TRPV1 receptor, the company hopes to downregulate neurogenic inflammation, promote thermogenesis and influence appetite regulation in a way that differs from, and potentially complements, current treatments.
Expects results prior to the TO2 strike period
The company has previously conducted two phase IIa studies in overweight people with type-2 diabetes, so there is experience in assessing the drug candidate in metabolic conditions. The next step is to now get solid proof-of-concept data from these first ongoing preclinical studies.
– It is very satisfying that the studies have now been initiated and in line with our communicated timelines to achieve results prior to our upcoming TO2 warrant strike period. We have a lot of prior clinical data on the safety and effects of XEN-D0501, and now we’re investigating the effects on obesity in relevant animal models. This will guide us on how to further progress the clinical development of XEN-D0501, CEO Gustav H. Gram comments.
The content of BioStock's news and analysis is independent, but BioStock's operations are to some extent financed by companies in the industry. This post refers to a company from which BioStock has received funding.