XEND · Clinical assessment of PILA PHARMA’s TRPV1 antagonist, XEN-D0501, as a novel type of oral anti-diabetic agent

The XEND project aims to take key steps towards establishing a transient receptor potential vanilloid (TRPV1) antagonist, XEN-D0501, as a novel oral treatment for Type 2 diabetes (T2D). Diabetes is a constantly growing global epidemic. According to recent estimation, 422 million people worldwide are affected by the disease with a prevalence rate of 8.3%, and 46.3% still remains undiagnosed.Due to high risks of complications and related problems from mismanagement, closely controlling the treatment of diabetes is a primary concern for physicians and patients alike. Most commonly, the first recommendation is to address poor dieting habits and lifestyle modifications. This is followed by the first-line treatment of Metformin, which is recommended as an oral anti-diabetes drug that is used to help control glycemic levels in patients with diabetes when lifestyle modifications alone are insufficient. Pila Pharma has identified key missing components in the treatment of T2D. Through the XEND project, we will validate and begin steps towards out-licencing the first TRPV1 antagonist that has potential to constitute the cornerstone of an innovative first in- class drug for T2D treatment. The market potential of XEN-D0501, lies in its capacity to fill the existing market niche for efficient and safe TRPV1 antagonists and offer a new treatment option with improved Quality of Life to the increasing number of T2D patients.Pila Pharma will use the SME Instrument (Phase 1 and 2) to prepare and conduct a full Phase 2 Clinical trial. Further, we will begin engaging potential partnerships to take the drug through Phase III trials and ultimately to market. The clinical uptake of XEN-D0501 in Europe will meet the clinical and socioeconomic needs associated with diabetes.