Lexicon announces presents data from Phase 2 PROGRESS study for pilavapadin

Lexicon (LXRX) Pharmaceuticals announced the presentation of clinical data from the company’s Phase 2b PROGRESS study for its investigational, AAK1-inhibitor, pilavapadin, for the treatment of diabetic peripheral neuropathic pain at two medical meetings. The Phase 2b, dose-finding PROGRESS study evaluated once daily pilavapadin doses of 10 mg, 20 mg, or 20 mg for seven days followed by 10 mg thereafter, in adults with DPNP. Based on results of the study, Lexicon identified pilavapadin 10 mg once daily as the most clinically meaningful dose. In a post-hoc analysis of the PROGRESS data, excluding the 20 mg arm, the pilavapadin 10 mg dose arms demonstrated nominally significant separation from placebo. Additionally, a clinically meaningful, two-point reduction from baseline in average daily pain scores was observed by week 11. The pilavapadin 10 mg dose was well tolerated with minimal discontinuations.