Lexicon presents additional pilavapadin data in DPNP

Lexicon (LXRX) Pharmaceuticals announced the Company presented additional clinical data and program updates from its Phase 2 pilavapadin program at the 19th Annual Pain Therapeutics Summit. These data follow the topline results from the Phase 2b PROGRESS study of pilavapadin in diabetic peripheral neuropathic pain announced in March of 2025, which identified 10 mg once daily as the most clinically meaningful and appropriate dose to advance into Phase 3 development. The additional analyses from the Phase 2 program resulted in four primary conclusions by the company with respect to the 10mg dose of pilavapadin: Validated biological activity, as evidenced by a linear relationship between increased plasma levels of pilavapadin and pain reduction. Clinically meaningful efficacy, with a 2-point average daily pain score reduction from baseline at 12 weeks. Acceptable tolerability profile, with placebo-like treatment completion rates. Acceptable safety profile in line with standard of care, further bolstered by subsequent studies showing no prolonged QTc interval with pilavapadin treatment and no significant impact on the pharmacokinetics of pilavapadin from mild to moderately impaired renal function. The data presentation included results from a post-hoc, pooled analysis of the Phase 2 RELIEF-DPN 1 and Phase 2b PROGRESS studies, which collectively enrolled more than 600 patients, designed to investigate the exposure-response relationship across the two Phase 2 studies, investigate the lack of efficacy of the 20 mg dose in the PROGRESS study, and confirm the robustness of the 10 mg dose for Phase 3 studies. Participants in the PROGRESS 20 mg dose arm were less adherent than participants in the other study arms, potentially driven by increased tolerability symptoms among patients receiving the 20mg dose and potentially driving the lack of observed dose response in that arm.