Lexicon Pharmaceuticals Announces Commencement of Dosing in Phase 2 Clinical Study of LX9211 in Post-Herpetic Neuralgia

Rhea-AI Summary

Lexicon Pharmaceuticals (Nasdaq: LXRX) has commenced patient dosing in the RELIEF-PHN 1 clinical study, evaluating LX9211 for post-herpetic neuralgia. This Phase 2, randomized, placebo-controlled trial will enroll approximately 74 patients across 30 sites, focusing on changes in Average Daily Pain Score over six weeks. LX9211, a selective AAK1 inhibitor, aims to provide a new treatment option as current therapies are limited. The company anticipates the completion of this trial along with another study for diabetic peripheral neuropathic pain by the end of next year.

Positive

• Commencement of RELIEF-PHN 1 clinical study for LX9211 enhances development pipeline.
• LX9211 is positioned to address significant unmet medical needs in post-herpetic neuralgia.
• The study includes 74 patients, indicating substantial trial scale and commitment to clinical research.

Negative

• The reliance on clinical trial outcomes introduces uncertainty regarding future market success.
• Limited existing treatment options may imply a high-risk environment for clinical failure.

THE WOODLANDS, Texas, Dec. 31, 2020 (GLOBE NEWSWIRE) -- Lexicon 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).

About LX9211

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.

Safe Harbor Statement

This press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position, long-term outlook on its business and the clinical development and therapeutic and commercial potential of its drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon’s 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 LX9211, sotagliflozin and its other potential drug candidates on its anticipated timelines, 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, 2019, 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:

Chas Schultz
Executive Director, Corporate Communications and Investor Relations
Lexicon Pharmaceuticals
(281) 863-3421
cschultz@lexpharma.com

FAQ

What is the RELIEF-PHN 1 study about?

The RELIEF-PHN 1 study evaluates the efficacy and safety of LX9211 for treating post-herpetic neuralgia.

How many patients will be enrolled in the RELIEF-PHN 1 study?

The study aims to enroll approximately 74 patients.

What is LX9211?

LX9211 is a potent oral small molecule inhibitor of AAK1 aimed at treating neuropathic pain.

What is the expected outcome timeline for the RELIEF-PHN 1 study?

The study is expected to be completed by the end of next year.

What are the primary endpoints of the RELIEF-PHN 1 study?

The primary efficacy endpoint is the change in Average Daily Pain Score from baseline to Week 6.