Core Insights - Lexicon Pharmaceuticals has advanced the 10 mg dose of pilavapadin into Phase 3 development following positive Phase 2 results in diabetic peripheral neuropathic pain (DPNP) [1][2] - The U.S. FDA has accepted the company's request for an end-of-Phase 2 meeting, and discussions with potential partners are ongoing [3] Company Updates - The Phase 2b PROGRESS study identified the 10 mg once daily dose as the most effective for further development [2] - Additional analyses from the Phase 2 program support the readiness of the 10 mg dose for Phase 3 studies, confirming its efficacy and tolerability [3][4] - The data presentation at the 19th Annual Pain Therapeutics Summit included a pooled analysis of over 600 patients, highlighting the robustness of the 10 mg dose [4] Clinical Data Highlights - The analyses concluded that there is a validated biological activity with a linear relationship between increased plasma levels of pilavapadin and pain reduction [8] - Clinically meaningful efficacy was demonstrated with a 2-point average daily pain score reduction from baseline at 12 weeks [8] - The tolerability profile was acceptable, with treatment completion rates similar to placebo [8] - Safety profile aligned with standard care, showing no prolonged QTc interval and no significant impact on pharmacokinetics from mild to moderately impaired renal function [8] Product Information - Pilavapadin (LX9211) is a selective, investigational small molecule inhibitor of AAK1, targeting neuropathic pain without affecting opiate pathways [6] - The drug has shown central nervous system penetration and reduction in pain behavior in preclinical models [6] Company Background - Lexicon Pharmaceuticals focuses on pioneering medicines that transform patients' lives, with a pipeline targeting various diseases including neuropathic pain and hypertrophic cardiomyopathy [7]