Lexicon Announces Completion of Enrollment in Phase 2B PROGRESS Study of LX9211 in Diabetic Peripheral Neuropathic Pain (DPNP)

Core Insights - Lexicon Pharmaceuticals has successfully completed patient enrollment in the PROGRESS study, exceeding the target by 20% with a total of 494 patients enrolled, and finishing eight weeks ahead of schedule [2][3][4] - Top-line data from the PROGRESS study is expected to be announced in Q1 2025, which will provide critical insights for the Phase 3 design of LX9211 [3][4] Study Details - The PROGRESS study is a Phase 2b trial evaluating LX9211 for diabetic peripheral neuropathic pain (DPNP), a condition with significant unmet treatment needs [2][5] - The primary endpoint of the study is the reduction of Average Daily Pain Score (ADPS) at 8 weeks, with secondary endpoints including changes in burning pain and pain interference with sleep [5] - The study design allows patients to maintain one stable-dose DPNP therapy, aligning with real-world treatment practices [5] Background on DPNP - Diabetic peripheral neuropathic pain (DPNP) affects approximately 5 million patients in the U.S., resulting from nerve damage due to chronically high blood sugar levels [6] - DPNP can lead to debilitating symptoms such as pain and numbness in extremities, highlighting the urgent need for new non-opioid treatment options [6][4] About LX9211 - LX9211 is a novel, orally delivered, selective small molecule inhibitor of adaptor-associated kinase 1 (AAK1), identified through Lexicon's gene science approach [7] - Preclinical studies have shown that LX9211 can penetrate the central nervous system and reduce pain behavior without affecting opiate pathways [7] - The drug has received Fast Track designation from the U.S. FDA for development in DPNP [7] Company Overview - Lexicon Pharmaceuticals is focused on pioneering medicines that transform patients' lives, utilizing its Genome5000™ program to identify therapeutic targets [8] - The company has a pipeline of drug candidates in various stages of development for conditions including neuropathic pain, hypertrophic cardiomyopathy, and obesity [8]