The Woodlands, Texas, October 24, 2022 - Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the following two oral presentations relating to its investigational drug LX9211 will be delivered virtually during the World Brain Disorders and Neuroscience Summit 2022 Hybrid in Munich, Germany:
- “Evaluation of LX9211 in the Treatment of Diabetic Peripheral Neuropathic Pain: Study Design and Topline Results from the RELIEF-DPN-1 Trial”, describes the positive results achieved in this proof-of-concept study and will be given on Saturday, October 29th at 3:25pm CEST/9:25am ET.
- “Evaluation of LX9211, a Potent, Selective Inhibitor of AAK1, in Preclinical Models of Spasticity”, describes the effect of LX9211 in reducing spasticity in established animal models and will be given on Monday, October 31st at 3:35pm CET/8:35am ET.
“We are committed to providing important information regarding our LX9211 neuropathic pain program to the scientific and medical communities,” said Dr. Craig Granowitz, Lexicon’s senior vice president and chief medical officer. “For the first time we are publicly discussing the potential utility of LX9211 in neurological conditions characterized by both spasticity and pain, such as multiple sclerosis and spinal cord injury. We are excited to share these promising preclinical data, which we plan to submit for publication in a peer-reviewed journal.”
Additional information on the World Brain Disorders and Neuroscience Summit 2022 can be found here.
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 dose of 100 mg followed by once-daily doses of 10 mg or an initial 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.
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. 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:
Lexicon Pharmaceuticals, Inc.
For Media Inquiries:
Lexicon Pharmaceuticals, Inc.