Lexicon Pharmaceuticals to Announce Topline Results from Phase 2b PROGRESS Study Evaluating Pilavapadin (LX9211) in Adults with Diabetic Peripheral Neuropathic Pain

Core Insights - Lexicon Pharmaceuticals announced a conference call and webcast to share topline results from the Phase 2b PROGRESS study evaluating pilavapadin (LX9211) for diabetic peripheral neuropathic pain (DPNP) [1][2] Group 1: PROGRESS Study Details - The PROGRESS study began in December 2023, enrolling 496 adult patients with diabetes and moderate to severe DPNP [3] - The study was placebo-controlled, with the primary endpoint being the change from baseline to Week 8 in the Average Daily Pain Score (ADPS) compared to placebo [3] - Three treatment groups received once-daily doses of pilavapadin: 10 mg, 20 mg, or 20 mg for seven days followed by 10 mg thereafter [3] - Secondary endpoints included changes in burning pain and pain interference on sleep from baseline to Week 8 [3] - Patients were allowed to remain on stable-dose DPNP therapies, aligning with practical usage of new DPNP drugs [3] Group 2: Diabetic Peripheral Neuropathic Pain (DPNP) - DPNP is a chronic complication of diabetes characterized by burning pain, numbness, and other symptoms in extremities [4] - Approximately 9 million patients in the U.S. suffer from DPNP [4] Group 3: Pilavapadin Overview - Pilavapadin (LX9211) is an investigational AAK1 inhibitor, designed to be a potent, once-daily, orally delivered small molecule [5] - It targets neuropathic pain by inhibiting neurotransmitter reuptake and recycling without affecting opiate pathways [5] - Preclinical studies indicated that pilavapadin penetrates the central nervous system and reduces pain behavior in neuropathic pain models [5] Group 4: Company Background - Lexicon Pharmaceuticals is focused on pioneering medicines that transform patients' lives through its Genome5000™ program [6] - The company has identified over 100 protein targets with therapeutic potential across various diseases [6] - Lexicon has advanced multiple medicines to market and has a pipeline of drug candidates in various stages of development, including heart failure, neuropathic pain, obesity, and diabetes [6]