PILA PHARMA has to date completed two phase 2a clinical trials, PP-CT01 and PP-CT02.
PP-CT01 demonstrated that single doses up to 8 mg XEN-D0501 is safe and well tolerated by people with type 2 diabetes.
Further, PP-CT02, demonstrated that multiple doses of XEN-D0501 (4 mg BID for 28 days) was likewise safe and well-tolerated by people with type 2 diabetes and also – with statistical significance versus placebo – enhance the endogenous insulin response to oral glucose, thus, demonstrating proof of principle.
Next step for PILA PHARMA is to advance XEN-D0501 towards a phase 2b trial in people with type 2 diabetes.
Further, the company aim at developing XEN-D0501 as treatment of erythromelalgia a painful, rare disease.
FIG.: Overall development plan for the company’s diabetes project (DM) as presented at the company’s IPO in July 2021 marked in blue and for the additional rare disease project within erythromelalgia (EM).