Lexicon Pharmaceuticals will announce topline results from its Phase 2b PROGRESS study of pilavapadin (LX9211) for diabetic peripheral neuropathic pain (DPNP) on March 3, 2025. The study evaluated the efficacy and safety of this oral, non-opioid, AAK1 inhibitor in adults with moderate to severe DPNP. The company hopes this novel approach to pain management will offer a new treatment option for this prevalent condition.
Positive results from the PROGRESS study could significantly impact the treatment landscape for DPNP. Current treatment options often provide inadequate pain relief or carry the risk of opioid dependence. Pilavapadin’s unique mechanism of action, targeting AAK1 to inhibit neurotransmitter reuptake without affecting opioid pathways, offers a potentially safer and more effective alternative. This could lead to improved quality of life for millions of patients suffering from this chronic and debilitating condition.
The PROGRESS study enrolled 496 patients with type 1 or type 2 diabetes and moderate to severe DPNP. The study used a placebo-controlled, dose-ranging design, evaluating three pilavapadin doses (10mg, 20mg, and 20mg followed by 10mg). The primary endpoint was the change in average daily pain score (ADPS) from baseline to Week 8. Importantly, the study allowed patients to continue their existing stable-dose DPNP medications, reflecting real-world treatment scenarios.
The upcoming announcement of the topline results will be a pivotal moment for Lexicon. Positive data could pave the way for a Phase 3 trial and eventual regulatory approval, potentially establishing pilavapadin as a valuable new treatment option for DPNP. This would validate Lexicon’s unique genomics-based drug discovery platform and strengthen its position in the pain management market. Furthermore, the novel mechanism of pilavapadin may stimulate further research into AAK1 inhibition for other neuropathic pain conditions.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
