Lexicon Pharmaceuticals (Nasdaq: LXRX) has announced the completion of screening for its Phase 2b PROGRESS trial evaluating LX9211 in patients with Diabetic Peripheral Neuropathic Pain (DPNP). The company anticipates completing enrollment ahead of schedule, with top-line data expected in Q1 2025, moving forward from the previously projected Q2 2025 timeline.
LX9211 is an orally-delivered, potent, selective, investigational small molecule inhibitor targeting adaptor-associated kinase 1 (AAK1). It has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of DPNP. The PROGRESS trial, initiated in December 2023, is designed to enroll adult patients diagnosed with moderate to severe DPNP, who are allowed to continue their existing pain management therapies. The primary endpoint of the study is the reduction in Average Daily Pain Score (ADPS) after 8 weeks of treatment.
Addressing Unmet Needs in Neuropathic Pain
According to Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer, there is a significant unmet need for novel, non-opioid treatments for neuropathic pain. "There have been no new, non-opioid medications approved for neuropathic pain in more than two decades, and there is an urgent need for novel treatment options," he stated. "We believe that LX9211 has the potential to positively impact the lives of people suffering with neuropathic pain."
Trial Design and Objectives
The Phase 2b PROGRESS trial is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study. It aims to assess the efficacy and safety of LX9211 in reducing pain in patients with DPNP. The trial's primary endpoint, the change in Average Daily Pain Score (ADPS) at 8 weeks, will provide critical data on the drug's potential to alleviate neuropathic pain.
About LX9211
LX9211 was discovered using Lexicon's unique approach to gene science. It is designed to selectively inhibit AAK1, a target identified by Lexicon as a promising approach for treating neuropathic pain. Preclinical studies have indicated that LX9211 can penetrate the central nervous system and reduce pain behavior in neuropathic pain models without affecting opiate pathways.
