Business
Lexicon Announces Positive Top-Line Results From Phase 2 Proof-Of-Concept Study Of LX9211 In Painful Diabetic Neuropathy
Study Supports Translation of Potential New Mechanism of Action for Neuropathic Pain and Advancement of LX9211 Development in Painful Diabetic Neuropathy
About this update from Lexicon Pharmaceuticals, Inc.
[{"type":"text","content":"Study Supports Translation of Potential New Mechanism of Action for Neuropathic Pain and Advancement of LX9211 Development in Painful Diabetic Neuropathy Conference Call and Webcast at 8:00 a.m. Eastern Time June 30, 2022 THE WOODLANDS, Texas, June 29, 2022 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced top-line results of RELIEF-DPN-1, its Phase 2 proof-of-concept study of LX9211 in painful diabetic neuropathy. LX9211 achieved the primary endpoint of the study, 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. Separation from placebo was seen by week 1 in both dose arms, and the effect was consistent across age, sex, concurrent use of medications for painful diabetic neuropathy, and baseline pain score. Patient reported outcomes (global impression of change) were improved in patients treated with LX9211 compared to placebo. Adverse events were more frequent in the LX9211 treatment arms and at the higher dose, with the most common being dizziness, headache and nausea. Nearly all adverse events were reported as mild or moderate. There were no drug-related serious adverse events reported in the study. A full analysis of the results from RELIEF-DPN-1 will be submitted for publication at an upcoming medical conference and in a peer-reviewed journal. “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,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. “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. This is an important step towards bringing the benefits of our science to patients, in an area where novel targets are rare and there is a tremendous need for new therapies.” LX9211 is a potent, orally delivered, selective small molecule inhibitor of AAK1, which preclinical studies h...