Lexicon Pharmaceuticals Highlights Scientific and Medical Presentations Relating to Its Successful Phase 2 Proof-Of-Concept Study of LX9211 in Painful Diabetic Neuropathy

Rhea-AI Summary

Lexicon Pharmaceuticals (Nasdaq: LXRX) announced significant advancements in its investigational drug LX9211, aimed at treating neuropathic pain. Key presentations include findings from the Phase 2 RELIEF-DPN-1 study at PAINWeek 2022 and the IASP World Congress. The study, involving 319 patients across 40 sites, showed statistically significant reductions in pain compared to placebo, with p-values of 0.007 and 0.030 for low and high-dose arms, respectively. The drug has received FDA Fast Track designation, enhancing its potential as a treatment for diabetic peripheral neuropathic pain.

Positive

• LX9211 demonstrated statistically significant pain reduction in the RELIEF-DPN-1 study with p-values of 0.007 and 0.030.
• The study enrolled 319 patients, indicating robust clinical interest and involvement.
• LX9211 received Fast Track designation from the FDA for diabetic peripheral neuropathic pain.

Negative

• None.

Poster and Oral Presentation at PAINWeek Describing a Novel Mechanism of Action for Neuropathic Pain

Poster at International Association for the Study of Pain (IASP) World Congress on Pain Describing Design Elements of the RELIEF-DPN-1 Study

Podium Presentation at 16^th Annual Pain Therapeutics Summit Discussing Full Results From the RELIEF-DPN-1 Study

THE WOODLANDS, Texas, Sept. 20, 2022 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced a series of scientific and medical presentations describing the progression of its investigational drug LX9211 from discovery to translation in a clinical proof-of-concept study.

• A poster was presented and an oral presentation was given on September 8^th and 9^th, respectively, at the PAINWeek 2022 National Conference on Pain Management in Las Vegas, Nevada.
  • The poster and presentation, each titled “LX9211, a Novel Therapeutic Approach to Treatment of Neuropathic Pain,” described the mechanism of action of LX9211’s novel target, adaptor-associated protein kinase 1 (AAK1), as well as results from multiple preclinical models of neuropathic pain after treatment with the potent AAK1 inhibitor LX9211.
• A poster will be presented today at 3:15pm ET at the IASP World Congress on Pain in Toronto, Canada. (https://iaspworldcongress2022.org/)
  • The poster, titled “Efficacy, Safety, and Pharmacokinetics of LX9211 in the Treatment of Diabetic Peripheral Neuropathic Pain (RELIEF-DPN 1),” outlines the unique study design, baseline patient characteristics, and the positive results of the primary endpoint of the study.
• An oral presentation will be given on November 14^th at 3:35pm ET at Arrowhead’s Annual Pain Therapeutics Summit in Washington, D.C. (https://www.paintherapeuticsummit.com/)
  • The presentation, titled “A Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of LX9211 in the Treatment of Diabetic Peripheral Neuropathic Pain (RELIEF-DPN 1),” will discuss the framework of the trial, the preclinical basis for the program, and a full analysis of the results from this positive proof-of-concept study.

“We believe the successful translation of a novel mechanism for the potential treatment of neuropathic pain could be transformational for patients,” said Dr. Craig Granowitz, Lexicon’s senior vice president and chief medical officer.   “We are excited to present these findings to the medical and scientific community and expect to communicate additional LX9211 clinical and preclinical data as they become available. Based on these results, we will expeditiously advance the clinical development of LX9211 for the treatment of neuropathic pain, an area of significant unmet clinical need.”

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 approximately 40 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.

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 Inquiries:

Mike Kelly
Lexicon Pharmaceuticals, Inc.
mkelly@lexpharma.com

FAQ

What were the key findings from the RELIEF-DPN-1 study for LX9211?

The RELIEF-DPN-1 study revealed statistically significant pain reductions of 1.39 points and 1.27 points in the low and high-dose arms of LX9211, respectively, compared to a 0.72 point reduction in the placebo group.

What is LX9211's mechanism of action?

LX9211 is a selective small molecule inhibitor of adaptor-associated kinase 1 (AAK1), targeting neuropathic pain pathways.

When will additional results for LX9211 be communicated?

Lexicon expects to share further LX9211 clinical and preclinical data as it becomes available, with plans to advance its clinical development.

What is the significance of the Fast Track designation for LX9211?

The Fast Track designation from the FDA highlights the potential of LX9211 as a treatment for diabetic peripheral neuropathic pain, facilitating expedited development and regulatory processes.

What are the next steps for Lexicon regarding LX9211?

Lexicon is moving forward with the clinical development of LX9211, following the positive results from the RELIEF-DPN-1 study.