Lexicon Pharmaceuticals Announces Commencement of Dosing in Phase 2 Clinical Study of LX9211 in Post-Herpetic Neuralgia
- Category: Small Molecules
- Published on Saturday, 02 January 2021 13:01
- Hits: 904
THE WOODLANDS, TX, USA I December 31, 2020 ILexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), announced today the commencement of patient dosing in RELIEF-PHN 1, a Phase 2 randomized, placebo-controlled, multi-center clinical study of LX9211 for the treatment of post-herpetic neuralgia. LX9211 is a potent oral small molecule inhibitor of adaptor associated kinase 1 (AAK1).
“We are pleased to commence dosing in our second proof-of-concept study of LX9211,” said Praveen Tyle, Ph.D., executive vice president of research and development. “People who develop shingles often suffer with persistent pain for months to years after the rash clears with limited treatment options. We believe LX9211 has the potential to offer a novel therapeutic approach to treating post-herpetic neuralgia. We look forward to completing this study and our other proof-of-concept study of LX9211 in diabetic peripheral neuropathic pain toward the end of next year.”
About the RELIEF-PHN 1 Study
RELIEF-PHN 1 is a Phase 2 randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy, safety and pharmacokinetics of LX9211 in the treatment of post-herpetic neuralgia. The study is designed to enroll approximately 74 patients at approximately 30 clinical sites. The primary efficacy endpoint under evaluation is the change from baseline (Day 1) to Week 6 in Average Daily Pain Score (ADPS), based on the 11-point numerical rating scale (NRS).
LX9211 is a potent, orally delivered, selective small molecule inhibitor of AAK1. Lexicon identified AAK1 in its target discovery efforts as a promising approach for the treatment of neuropathic pain, and identified LX9211 and another development candidate in a neuroscience drug discovery alliance with Bristol-Myers Squibb from which Lexicon holds exclusive development and commercialization rights. Preclinical studies of LX9211 demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways. LX9211 has received Fast Track designation from the U.S. Food and Drug Administration for the development in diabetic peripheral neuropathic pain.
About Lexicon Pharmaceuticals
Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through its Genome5000™ program, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon advanced one of these medicines to market and has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, heart failure, diabetes and metabolism and other indications. For additional information, please visit www.lexpharma.com.
SOURCE: Lexicon Pharmaceuticals