Lexicon Pharmaceuticals (NASDAQ:LXRX) reported positive topline results from the Phase 2 proof-of-concept study of its lead candidate LX9211 in painful diabetic neuropathy.
The RELIEF-DPN-1 is the first of two Phase 2 proof-of-concept study designed to evaluate LX9211 in patients with neuropathic pain.
In this study, LX9211 has achieved the primary endpoint, demonstrating a statistically significant reduction in average daily pain score (ADPS) at week 6 compared to placebo in the low dose arm with results that plateaued in the high dose arm.
Craig Granowitz, Senior vice president and chief medical officer, commented : “The results of this study support the translation of a potential new mechanism of action for neuropathic pain and serve as a testament to the strength of Lexicon's science. Our scientists were the first to identify AAK1 as a novel target with potential for the treatment of neuropathic pain, making an initial discovery in knockout mice, validating that discovery in collaboration with Bristol-Myers Squibb with small molecule inhibition of the target in animal models, and now translating that discovery in this human clinical proof-of-concept study. “
LX9211 is also under evaluation in RELIEF-PHN-1, the second Phase 2 study in patients with post-herpetic neuralgia. Lexicon expects top-line results around the end of the third quarter of 2022.
The company noted that complete analysis of the results from RELIEF-DPN-1 will be submitted for publication at an upcoming medical conference and in a peer-reviewed journal.
Lexicon shares are trading higher 20 percent at $2.68 during after hours session on the last check Wednesday.
