Core Insights - Lexicon Pharmaceuticals presented clinical data from the Phase 2b PROGRESS study for pilavapadin, an AAK1-inhibitor for diabetic peripheral neuropathic pain (DPNP), showing a two-point reduction in average daily pain scores by week 11 [1][3] - Pilavapadin has the potential to be the first non-opioid oral medication approved for DPNP in over two decades, with the company looking forward to Phase 3 trials [2][5] Study Results - The PROGRESS study evaluated once daily doses of pilavapadin (10 mg, 20 mg) in adults with DPNP, identifying 10 mg as the most clinically meaningful dose [2][3] - A post-hoc analysis indicated significant separation from placebo for the 10 mg dose, with a clinically meaningful reduction in pain scores observed [3] - The 10 mg dose was well tolerated, with minimal discontinuations reported [3] Disease Context - DPNP is a common and debilitating complication of diabetes, affecting approximately 30% of type 1 diabetes patients and 50% of type 2 diabetes patients, with around nine million patients in the U.S. suffering from this condition [4] - There is a significant need for new non-opioid treatments for DPNP, as current options are limited [4] About Pilavapadin - Pilavapadin (LX9211) is a selective, investigational small molecule that inhibits AAK1, targeting neuropathic pain without affecting opiate pathways [6] - Preclinical studies have shown its effectiveness in reducing pain behavior while penetrating the central nervous system [6] About the PROGRESS Study - The PROGRESS study began in December 2023, enrolling 496 adult patients with moderate to severe DPNP, and was designed to evaluate the efficacy of pilavapadin against placebo [7][8] Company Overview - Lexicon Pharmaceuticals focuses on pioneering medicines through its Genome5000™ program, identifying therapeutic targets for various diseases, including neuropathic pain [9]