Clinical development

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.