Press release
Pilavapadin Provides Meaningful Pain Reduction in Adults with Diabetic Peripheral Neuropathic Pain (DPNP) in Data Presented at the European Association for the Study of Diabetes (EASD) and NEUROdiab Annual Meetings
Pilavapadin 10 mg resulted in a two-point reduction from baseline in average daily pain scores (ADPS) by week 11 and was well tolerated in PROGRESS Phase 2b
About this update from Lexicon Pharmaceuticals, Inc.
[{"type":"text","content":"Pilavapadin 10 mg resulted in a two-point reduction from baseline in average daily pain scores (ADPS) by week 11 and was well tolerated in PROGRESS Phase 2b study\nTHE WOODLANDS, Texas, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today 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 (DPNP) at two medical meetings: “New Promise for Painful Diabetic Neuropathy: Results from recently finished clinical trials of Pilavapadin, an oral, non-opioid, AAK1 inhibitor for diabetic peripheral neuropathic pain” was presented on Saturday, September 13, 2025, during an oral presentation at the NEUROdiab Annual Meeting.“Pilavapadin, an oral, non-opioid, AAK1 inhibitor for diabetic peripheral neuropathic pain (DPNP): results from a Phase 2b, dose-ranging, randomized, placebo-controlled, multicenter study” was presented on Wednesday, September 17, 2025, during an oral presentation at the 2025 European Association for the Study of Diabetes (EASD) Annual Meeting. “The data presented at NEUROdiab and EASD provide additional support for our understanding of pilavapadin’s profile, as well as its potential as a much-needed new therapy for DPNP,” said Suma Gopinathan, Lexicon’s Senior Vice President, Discovery. “Pilavapadin has potential to become the first non-opioid, oral medication approved for DPNP in over two decades. We look forward to Phase 3 trials for this potential new therapy.” Study Results 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 (p “DPNP is a highly prevalent, but often overlooked, debilitating, chronic complication of diabetes in need of new non-opioid treatments,” said Rodica Pop-Busui M.D., Ph.D., Jordan Schnitzer Chair in Diabetes, Professor of Medicine and Division Head, Endocrinology, Diabetes and Clinical Nutrition Director, Harold Schnitzer Diab...