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]

Core Insights - Lexicon Pharmaceuticals is presenting clinical data for pilavapadin, an investigational AAK1-inhibitor aimed at treating diabetic peripheral neuropathic pain (DPNP) at multiple medical meetings [1][5][6] Group 1: Clinical Data and Presentations - The clinical data will be discussed at three upcoming medical meetings: NeuroDiab in Bucharest, EASD in Vienna, and Arrowhead's Annual Pain Therapeutics Summit in San Diego [2][3][4] - A specific presentation titled "New Promise for Painful Diabetic Neuropathy" will take place on September 13, 2025, by Dr. Rodica Pop-Busui [7] - The Phase 2b study results will be presented on September 17, 2025, also by Dr. Rodica Pop-Busui, focusing on pilavapadin's efficacy in DPNP [7] Group 2: Product Information - Pilavapadin (LX9211) is a once-daily, orally delivered, selective small molecule inhibitor of AAK1, which targets neuropathic pain without affecting opiate pathways [5] - Preclinical studies indicate that pilavapadin penetrates the central nervous system and reduces pain behavior in neuropathic pain models [5] Group 3: Company Overview - Lexicon Pharmaceuticals is focused on pioneering medicines that transform patients' lives, utilizing its Genome5000™ program to identify therapeutic protein targets [6] - The company has a pipeline of drug candidates in various stages of discovery and development, addressing multiple indications including neuropathic pain and metabolic disorders [8]

Core Insights - Lexicon Pharmaceuticals is presenting data on diabetic peripheral neuropathic pain (DPNP) at the 7th Annual Meeting of the American Society of Pain and Neuroscience, highlighting the impact of DPNP on patients despite standard treatments [1][2] - Approximately 9 million patients in the U.S. suffer from DPNP, affecting 30% of type 1 diabetes patients and 50% of type 2 diabetes patients [2] - The study aims to raise awareness among healthcare professionals about the burden of DPNP on patients and encourage discussions about treatment options [3] Product Development - Pilavapadin (LX9211) is an investigational, non-opioid treatment for DPNP, discovered through Lexicon's gene science approach, targeting AAK1 to inhibit pain signaling without affecting opiate pathways [4] - The Phase 2a proof-of-concept RELIEF-DPN-1 study demonstrated that pilavapadin met its primary endpoint by reducing average daily pain scores (ADPS) at week 6 compared to placebo, showing significant benefits in alleviating DPNP symptoms [5] - Pilavapadin has received Fast Track designation from the U.S. FDA for its development in treating DPNP [5] Company Overview - Lexicon Pharmaceuticals focuses on pioneering medicines that transform patients' lives, utilizing its Genome5000™ program to identify therapeutic protein targets across various diseases [6] - The company has a pipeline of drug candidates in clinical and preclinical development for conditions including neuropathic pain, hypertrophic cardiomyopathy, and obesity [6]