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THE WOODLANDS, Texas - Lexicon Pharmaceuticals , Inc. (NASDAQ:LXRX), currently trading at $0.70 with a market cap of $253 million, reported positive topline results from the PROGRESS Phase 2b study of pilavapadin, a non-opioid treatment for diabetic peripheral neuropathic pain (DPNP). The study met its objectives, showing the 10 mg dose of pilavapadin provided significant pain reduction and improved tolerability over placebo. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 7.45, though it’s experiencing significant cash burn.
The PROGRESS study, which began in December 2023, enrolled 496 adult patients and examined the efficacy of pilavapadin without the loading dose that was used in the earlier RELIEF-DPN-1 trial. The 10 mg dose achieved a reduction in average daily pain score (ADPS) from baseline to Week 8, with fewer adverse events compared to higher doses and placebo. This development comes as the stock has seen a significant decline, down 72% over the past year, though InvestingPro analysis suggests the stock may be undervalued at current levels.
Despite the 20 mg dose not reaching statistical significance on the primary endpoint, the 10 mg dose arm showed a clear effect, with early and sustained separation from placebo. Most adverse events were mild or moderate, with dizziness and nausea being the most common.
Rodica Pop-Busui M.D., Ph.D., lead investigator, highlighted the urgent need for new non-opioid treatments for DPNP, which affects quality of life for millions. Lexicon CEO Mike Exton expressed confidence in pilavapadin’s potential, positioning it as the first oral non-opioid treatment for neuropathic pain in two decades.
The company plans to advance the 10 mg dose of pilavapadin into Phase 3 development based on the combined results of the PROGRESS and RELIEF-DPN-1 studies. A full analysis of the PROGRESS study will be presented at an upcoming medical conference and submitted for publication.
Pilavapadin, an AAK1 inhibitor, has been granted Fast Track designation by the FDA for DPNP development. Lexicon aims to address the significant demand for innovative DPNP treatments and is accelerating partnership discussions while preparing for Phase 3 trials.
This announcement is based on a press release by Lexicon Pharmaceuticals.
In other recent news, Lexicon Pharmaceuticals has been notified by the Nasdaq Stock Market that it no longer meets the minimum bid price requirement, as its stock has closed below $1 per share for 31 consecutive business days. The company has until July 2, 2025, to regain compliance by maintaining a closing bid price of at least $1 per share for ten consecutive business days. Additionally, Lexicon Pharmaceuticals announced the appointment of Scott M. Coiante as Senior Vice President and Chief Financial Officer, following the departure of Kristen L. Alexander from the CFO role. Coiante brings extensive experience from previous roles at Agile Therapeutics (OTC:AGRX) and Aprea Therapeutics (NASDAQ:APRE). Meanwhile, H.C. Wainwright has reaffirmed its Buy rating for Lexicon Pharmaceuticals, highlighting the upcoming Phase 2 PROGRESS data readout for LX9211, expected in the first quarter of 2025. Piper Sandler has also mentioned Lexicon Pharmaceuticals in its report on key Phase 2b readouts expected in 2025. These developments reflect ongoing strategic and financial adjustments at Lexicon Pharmaceuticals, as the company navigates compliance challenges and advances its clinical pipeline.
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