PILA PHARMA has announced 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, states the company. Further, the patients receiving XEN-D0501 with statistical significance demonstrated an enhanced insulin response to an oral glucose tolerance test conducted on day 28.
“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.”
“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.”
New member of the Board and PILA PHARMA’s first CFO
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 clinical researcher in diabetes with a special interest in the effects of insulin in diabetes.
Further, Lars Bukhave Rasmussen will join the management team in becoming the first Chief Financial Officer in PILA PHARMA. He brings significant business experience within the full pharma value chain to the company, 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 2 / 2 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. C
“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 PHARMA’s core assets both from a scientific, market and financial perspective going forward,” says Dorte X. Gram.
Photo of Dorte X. Gram: Jenny Leyman