GlobeNewswire Inc | Jan 13, 2022 09:00AM EST

January 13, 2022

NDA submitted for sotagliflozin in heart failure with an expected launch in 2H 2022, if approved

LX9211 neuropathic pain Phase 2 studies expected to read out in 1H 2022

THE WOODLANDS, Texas, Jan. 13, 2022 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) is outlining major potential value drivers for 2022 at this mornings presentation at the 40th Annual J.P. Morgan Healthcare Conference.

Lexicon submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in December 2021 for the approval of sotagliflozin to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent visits for heart failure in adult patients with type 2 diabetes. In the NDA, Lexicon is seeking a potentially unique label addressing recent and worsening heart failure, based on the landmark SOLOIST-WHF study. Importantly, the proposed NDA label encompasses patients across the spectrum of left ventricular ejection fraction (LVEF). If approved, Lexicon expects to commercially launch sotagliflozin in the United States in the second half of 2022. Lexicon will outline additional details and information about its commercial strategy in todays presentation.

In addition, Lexicon is looking forward to near-term results from two Phase 2 proof-of-concept studies of LX9211 in neuropathic pain. LX9211 is a potent, orally delivered, selective small molecule inhibitor of adaptor associated kinase 1 (AAK1), a novel target first identified using Lexicons technology platform as having promise for the treatment of neuropathic pain. Results from these two studies are expected in the first half of 2022.

We enter 2022 focused on these two objectives that each have the potential to drive major value for our stakeholders, said Lonnel Coats, Lexicons chief executive officer. Both heart failure and neuropathic pain represent multi-billion dollar markets of high unmet need and, if successful, we believe that both of these investigational products have blockbuster potential.

Today at 10:30 a.m. ET, Mr. Coats will present virtually at the 40th Annual J.P. Morgan Healthcare Conference. A webcast of the event will be available in the Events section of the Lexicon website at www.lexpharma.com.

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 Lexicons financial position and long-term outlook on its business, including the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of sotagliflozin, LX9211 and its other potential drug candidates. In addition, this press release also contains forward looking statements relating to Lexicons 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 managements current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicons 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, 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 Lexicons 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 Lexicons annual report on Form 10-K for the year ended December 31, 2020, 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 SchultzExecutive Director, Corporate Communications and Investor RelationsLexicon Pharmaceuticals(281) 863-3421cschultz@lexpharma.com