GlobeNewswire Inc | Aug 30, 2021 07:00AM EDT

August 30, 2021

New guidelines from the European Society of Cardiology recommend addition of SGLT inhibitors to standard of care for patients with acute and chronic heart failure.

Guidance underscores the benefits of SGLT inhibitors in significantly reducing risk of death due to cardiovascular causes or heart failure hospitalization.

THE WOODLANDS, Texas, Aug. 30, 2021 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) welcomes the new recommendation by the European Society of Cardiology (ESC) to add SGLT inhibitors as part of the standard of care for the prevention and treatment of heart failure (HF). SGLT inhibitors have been given a Class IA recommendation-- the strongest endorsement-- in updated clinical practice guidelines released by the ESC Heart Failure working group in the EU at its annual meeting, the ESC Congress 2021 - The Digital Experience.

Specifically, the guidelines recommend the following for the primary prevention of HF in patients with risk factors for its development:

-- SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, sotagliflozin) are recommended in patients with diabetes at high risk of cardiovascular (CV) disease or with CV disease in order to prevent HF hospitalizations.

The guidelines recommend the following for the treatment of patients with HF and diabetes or for the treatment of diabetes in HF:

-- SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, sotagliflozin) are recommended in patients with type 2 diabetes mellitus (T2DM) at risk of CV events to reduce hospitalizations for HF, major CV events, end-stage renal dysfunction, and CV death. -- SGLT2 inhibitors (dapagliflozin, empagliflozin, and sotagliflozin) are recommended in patients with T2DM and heart failure with reduced ejection fraction (HFrEF) to reduce hospitalizations for HF and CV death.

The guidelines also addressed worsening heart failure, noting:

-- The combined SGLT-1 and 2 inhibitor, sotagliflozin, has also been studied in patients with diabetes who were hospitalized with HF. The drug reduced CV death and hospitalization for HF. -- Safety and better outcome have also been recently shown in a prospective randomized trial with sotagliflozin in diabetic patients hospitalized for HF, irrespective of their left ventricular ejection fraction (LVEF).

It is quite rare for an investigational drug to be listed in the guidelines prior to regulatory approval and we do not take the trust and confidence that ESC has placed in sotagliflozin lightly, said Craig Granowitz, M.D., Ph.D., senior vice president and chief medical officer at Lexicon. We know patients with heart failure suffer reduced quality of life and remain at high risk of hospitalization or death, and these new guidelines are a strong call to action to ensure patients receive the most effective therapies for acute and chronic heart failure. We continue to work diligently for these patients and plan to submit a New Drug Application with the U.S. Food and Drug Administration later this year for its review of sotagliflozin, as a therapy for people suffering from heart failure and living with type 2 diabetes.

The full 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure can be found at escardio.org.

About SotagliflozinDiscovered using Lexicons unique approach to gene science, sotagliflozin is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Sotagliflozin is approved in the European Union (EU) for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes with a body mass index 27 kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy, but has not yet been commercially launched. Sotagliflozin is not approved for use in any other indications, including heart failure.

About Lexicon PharmaceuticalsLexicon 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 StatementThis press release contains forward-looking statements, including statements relating to Lexicons clinical development of and regulatory filings for sotagliflozin and the therapeutic and commercial potential of sotagliflozin. This press release also contains forward-looking 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 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 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 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