Dow Jones, Nasdaq, S&P 500 weekly preview: Big earnings week on tap after pullback
Investing.com -- Shares of Lexicon Pharmaceuticals , Inc. (NASDAQ:LXRX) tumbled 55% after the company announced topline results from its PROGRESS Phase 2b study, which evaluated pilavapadin in patients with diabetic peripheral neuropathic pain (DPNP).
Despite achieving all objectives for the 10 mg dose in the study, the lack of statistical significance on the primary endpoint caused the stock to fall sharply.
The PROGRESS study aimed to identify a dose of pilavapadin that offered meaningful pain reduction and improved tolerability. While the 10 mg dose showed clear evidence of effect and was well-tolerated, the 20 mg dose did not demonstrate a statistically significant separation from placebo, leading to a failure to meet the primary endpoint with a p-value of 0.11.
The study’s results indicated that all pilavapadin treatment arms reduced the mean average daily pain score (ADPS) from baseline to Week 8, with the 10 mg, 20 mg/10 mg, and 20 mg dose arms achieving reductions of 1.74, 1.70, and 1.38, respectively, compared to a reduction of 1.31 in the placebo arm. Despite these reductions, the lack of a significant dose-response signal has cast doubt on the drug’s efficacy, particularly at higher doses.
Adverse events were more frequent in the pilavapadin treatment arms but showed improvement from the previous RELIEF-DPN-1 study. Dizziness and nausea were the most common adverse events, with the highest incidence at the 20 mg dose.
Lexicon’s CEO, Mike Exton, Ph.D., expressed confidence in the 10 mg dose for Phase 3 development, citing the multibillion-dollar neuropathic pain market and the potential of pilavapadin to be the first oral non-opioid treatment approved for neuropathic pain in two decades. The company plans to accelerate discussions with potential partners while preparing for Phase 3 trials.
Rodica Pop-Busui M.D., Ph.D., lead investigator of the PROGRESS study, highlighted the need for new, non-opioid treatment options for DPNP, a condition that severely impacts the quality of life for those affected. The PROGRESS study results suggest that AAK1 inhibition by pilavapadin may offer an alternative to opioid use, providing clinically meaningful reductions in pain.
Lexicon will submit a full analysis of the PROGRESS study for presentation at a forthcoming medical conference and for publication in a peer-reviewed journal.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.