Lexicon Announces Series of Presentations Relating to LX9211, Its Investigational Drug for the Treatment of Diabetic Peripheral Neuropathic Pain (DPNP)

Five upcoming scientific presentations will add to the body of evidence supporting the advancement of LX9211 into late-stage development

Phase 2b dose optimization study planning underway, with initiation of dosing expected before the end of 2023, and extension to run in parallel with next-stage Phase 3 studies

THE WOODLANDS, Texas, Sept. 07, 2023 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced a series of five upcoming scientific presentations on its investigational drug LX9211, which is being evaluated in clinical trials for the treatment of diabetic peripheral neuropathic pain (DPNP). Data will be shared through four oral presentations and one poster presentation at various global Congresses.

Presentations are as follows:

• NeuPSIG 2023 International Congress on Neuropathic Pain, Sept. 7-9; Lisbon, Portugal; Poster Presentation
• 33^rd Annual Meeting of the Diabetic Neuropathy Study Group (NeuroDiab), Sept. 28-Oct. 1; Thessaloniki, Greece; Oral Presentation
• 59^th Annual Meeting of the European Association for the Study of Diabetes (EASD), Oct. 2-6; Hamburg, Germany and online; Oral Presentation
• 17^th Annual Pain Therapeutics Summit (Arrowhead Conference), Oct. 19-20; San Diego, California; Oral Presentation
• 2^nd World Brain Disorders and Neuroscience Summit (BDNS), Nov. 9-11; Singapore and online; Oral Presentation

Last month, Lexicon reiterated its plans to advance LX9211 into late-stage development in a clinical program directed towards an application for regulatory approval in DPNP. The first late-stage study will be a Phase 2b dose optimization study, with study planning underway and initiation of dosing expected before the end of 2023. The Phase 2b study includes an extension to run in parallel with planned next-stage Phase 3 studies.

“We look forward to reviewing our data with medical and scientific community members who share our commitment to addressing the unmet needs of DPNP patients,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. “Presentations at Congresses around the world can help build awareness of the LX9211 clinical data obtained to date and LX9211’s potential to become a new, non-opioid option for people suffering from DPNP.”

LX9211 has received Fast Track designation from the U.S. Food and Drug Administration for development in DPNP.

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 treat diseases safely and effectively. Lexicon is commercially launching one of these medicines, INPEFA^® (sotagliflozin), in the United States and has a pipeline of other promising drug candidates in discovery and preclinical and clinical development in neuropathic pain, diabetes and metabolism and other indications. For additional information, please visit www.lexpharma.com.

About LX9211

Discovered using Lexicon’s unique approach to gene science, LX9211 is a potent, orally delivered, selective, investigational 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 development in diabetic peripheral neuropathic pain.

Safe Harbor Statement

This press release contains “forward-looking statements,” including statements relating to the therapeutic and commercial potential, research and clinical development and regulatory status of LX9211. In addition, this press release also contains forward looking statements relating to 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 commercialize INPEFA^® (sotagliflozin) in heart failure on the timeline and/or at the prices currently contemplated or at all, conduct preclinical and clinical development and obtain necessary regulatory approvals of INPEFA (in other indications), LX9211 and its other 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, 2022 and other subsequent disclosure documents 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:
Carrie Siragusa
Lexicon Pharmaceuticals, Inc.
csiragusa@lexpharma.com

For Media Inquiries:
Alina Cocuzza
Lexicon Pharmaceuticals, Inc.
acocuzza@lexpharma.com