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Lexicon Announces Topline Results From Phase 2 Proof-of-Concept Study of LX9211 in Postherpetic Neuralgia
LX9211 demonstrated clear evidence of effect, achieving Lexicon’s goal for the study of supporting advancement in another indication within neuropathic pain
About this update from Lexicon Pharmaceuticals, Inc.
[{"type":"text","content":"LX9211 demonstrated clear evidence of effect, achieving Lexicon’s goal for the study of supporting advancement in another indication within neuropathic pain Consistent reduction in ADPS compared to placebo throughout dosing period, statistically significant when measured across dosing period, but not reaching significance at Week 6 primary endpoint Adverse event profile consistent with that observed in prior Phase 2 study Conference Call and Webcast Today at 5:00 pm ET Hosted by Lexicon Management THE WOODLANDS, Texas, Dec. 21, 2022 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced topline results of RELIEF-PHN-1, its Phase 2 proof-of-concept study of LX9211 in postherpetic neuralgia. LX9211 achieved a reduction in average daily pain score (ADPS) of 2.42 from baseline at week 6 compared to a reduction of 1.62 in the placebo arm, with a placebo adjusted difference of 0.80 (p=0.12). Although these results did not reach statistical significance on the primary endpoint of the study, overall study results demonstrated clear evidence of effect. Separation of LX9211 from placebo on ADPS was seen at week 1 and maintained consistently thereafter, with an average placebo adjusted reduction over the 6 Week dosing period of 0.80 (p=0.03). A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d64d9848-3c4c-43a5-a8d6-09b3b7123b6f “These results in postherpetic neuralgia achieve our goal for this small, 79-patient study of establishing clear evidence of effect supporting the further development of LX9211 in another neuropathic pain condition,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. “The RELIEF-PHN-1 study results are broadly consistent with the results achieved in our positive Phase 2 study of LX9211 in painful diabetic neuropathy (RELIEF-DPN-1) which enrolled over 300 patients. These results bolster our confidence in moving the LX9211 clinical program forward in hopes of delivering a potential solution for neuropathic pain patients in need of additional treatment options.” Notably, the study included only the higher of the two doses evaluated in RELIEF-DPN-1. The lower dose arm (100 mg on Day 1 and 10 mg thereafter) in RELIEF-DPN-1 demonstrated statistically significant results on ADPS and meaningfully bet...