Lexicon Pharmaceuticals Highlights Oral Presentation of Final Results From the RELIEF-DPN-1 Trial of LX9211 at the 16th Annual Pain Therapeutics Summit
Lexicon Pharmaceuticals (Nasdaq: LXRX) announced the final results from its Phase 2 RELIEF-DPN-1 trial for LX9211, a selective AAK1 inhibitor, aimed at treating diabetic peripheral neuropathic pain. The results will be presented on November 14, 2022, showing a significant reduction in pain scores compared to placebo. The study enrolled 319 patients across 45 clinical sites, demonstrating potential efficacy and safety. The company also plans to release results from another related study by year-end 2022.
- The Phase 2 RELIEF-DPN-1 study showed significant pain reduction with LX9211, achieving p-values of 0.007 and 0.030.
- LX9211 received Fast Track designation from the U.S. FDA for diabetic peripheral neuropathic pain treatment.
- None.
Conference Call and Webcast at 5:00pm ET on November 14, 2022, Following the Oral Presentation
THE WOODLANDS, Texas, Nov. 08, 2022 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the final results from the Phase 2 RELIEF-DPN-1 trial of its investigational drug LX9211, a novel, highly selective inhibitor of adaptor-associated kinase 1 (AAK1), will be presented during a podium presentation at the 16th Annual Pain Therapeutics Summit in Washington, D.C.
The presentation will be given by Anand Patel, M.D., the Chief Medical Officer at Conquest Research and a principal investigator in the RELIEF-DPN-1 study, on November 14th at 3:35pm ET, and is entitled:
- “A Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of LX9211 in the Treatment of Diabetic Peripheral Neuropathic Pain (RELIEF-DPN-1).”
The presentation will describe the preclinical basis for the program, the framework of the trial, and an analysis of the final results from this successful proof-of-concept study.
Following the presentation, Dr. Patel will join Lexicon management on a live conference call and webcast at 5:00pm ET to discuss the study results. The dial-in number for the conference call is 888-886-7786 and the conference ID for all callers is 28989106. The live webcast and replay may be accessed by visiting Lexicon’s website at www.lexpharma.com/events. An archived version of the webcast will be available on the website for 14 days.
About the RELIEF-DPN-1 Study
RELIEF-DPN-1 was a Phase 2 randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy, safety and pharmacokinetics of LX9211 in the treatment of painful diabetic neuropathy, also referred to as diabetic peripheral neuropathic pain. The study enrolled 319 patients at 45 U.S. clinical sites, evaluating three treatment groups receiving placebo or one of two dosing regimens of LX9211 (an initial single dose of 100 mg followed by once-daily doses of 10 mg or an initial single dose of 200 mg followed by once-daily doses of 20 mg). The primary efficacy endpoint under evaluation was the change from baseline to week 6 in ADPS, based on the 11-point numerical rating scale. The results of the study on the primary endpoint showed a reduction from baseline in ADPS of 1.39 points (p=0.007 versus placebo) in the low dose arm and 1.27 points (p=0.030 versus placebo) in the high dose arm, compared to 0.72 in the placebo arm. Under the statistical analysis plan for the study, a p-value of less than 0.028 was considered statistically significant.
The RELIEF-DPN-1 study was the first of two Phase 2 proof-of-concept studies evaluating LX9211 in neuropathic pain. LX9211 is also under evaluation in RELIEF-PHN-1, a study in patients with post-herpetic neuralgia, from which Lexicon is targeting top-line results around the end of the fourth quarter of 2022.
About LX9211
Discovered using Lexicon’s unique approach to gene science, LX9211 is a potent, orally delivered, selective small molecule inhibitor of adaptor-associated kinase 1 (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 heart failure, neuropathic pain, diabetes and metabolism and other indications. For additional information, please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to the clinical development of and potential therapeutic and commercial potential of LX9211. In addition, this press release also contains forward looking statements relating to the clinical development of, regulatory filings for and potential therapeutic and commercial potential of sotagliflozin and Lexicon’s other potential drug candidates, as well as Lexicon’s financial position and long-term outlook on its business, growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of sotagliflozin, LX9211 and its other potential drug candidates on its anticipated timelines, successfully commercialize any products for which it obtains regulatory approval, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
For Investor Inquiries:
Mike Kelly
Lexicon Pharmaceuticals, Inc.
mkelly@lexpharma.com
For Media Inquiries:
Alina Kolomeyer
Lexicon Pharmaceuticals, Inc.
akolomeyer@lexpharma.com
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