Lexicon’s Sotagliflozin Demonstrates Benefits in Heart Failure and Blood Glucose Control Across the Full Range of Kidney Function in New Analysis of Clinical Data

Post hoc analysis of pooled clinical data from the SOLOIST and SCORED trials supporting benefit of sotagliflozin presented at the virtual American Heart Association Scientific Sessions 2021, including:

• Sotaglifozin significantly reduced total cardiovascular deaths, hospitalizations for heart failure, and urgent visits for heart failure across the full range of kidney function studied.
• Sotaglifozin also significantly reduced hemoglobin A1c, a goal of diabetes management, across the full range of kidney function studied, including individuals with moderate-to-severe chronic kidney disease.

THE WOODLANDS, Texas, Nov. 14, 2021 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that a new analysis evaluating the clinical benefit of Lexicon’s investigational drug, sotagliflozin, in heart failure and blood glucose control across the full range of kidney function was presented at the virtual American Heart Association Scientific Sessions 2021.

The new analysis was presented by the study chair for the SOLOIST and SCORED trials, Deepak L. Bhatt, M.D., M.P.H., executive director of Interventional Cardiovascular Programs at Brigham and Women's Hospital, and professor of medicine at Harvard Medical School. The presentation, broadcast at 8:24 a.m. ET today and entitled, “Cardiovascular Benefits of Sodium Glucose Cotransporter-1/2 Inhibition with Sotagliflozin Across Baseline Kidney Function,” can be downloaded from the AHA website.

Heart and kidney disease are often interconnected, with chronic kidney disease considered to be an independent risk factor for heart failure and cardiovascular disease.ⁱ   It is estimated that around half of patients with type 2 diabetes have chronic kidney disease.ⁱⁱ  

“In this new analysis of pooled clinical data from the SOLOIST and SCORED trials, sotagliflozin consistently reduced total cardiovascular deaths, hospitalizations for heart failure, and urgent visits for heart failure across the full range of kidney function,” said Dr. Bhatt. “Sotagliflozin, with its dual mechanism of SGLT1 and SGLT2 inhibition, also significantly reduced hemoglobin A1c across the full range of kidney function studied, including patients with severe renal impairment or an estimated glomerular filtration rate between 25 and 30 ml/min/1.73m², with a magnitude of effect that has not been reported in studies of selective SGLT2 inhibitors.”

The pooled analysis of clinical data from the SOLOIST and SCORED trials involved a total of 11,806 patients with diabetes and heart failure or cardiovascular risk factors.

“This continued research provides further evidence of the rapid, robust and broad benefits observed in the SOLOIST and SCORED studies of sotagliflozin in heart failure,” said Lexicon senior vice president and chief medical officer Craig B. Granowitz, M.D., Ph.D. “We believe these results will strengthen the new drug application we plan on filing with the U.S. Food and Drug Administration around year-end. If approved, we believe sotagliflozin has the potential to become an important new therapeutic option for heart failure in patients with type 2 diabetes. With its unique dual SGLT1 and SGLT2 inhibition, sotagliflozin continues to show benefits we believe to be differentiating for a broad range of patients suffering from heart failure or at a higher risk for heart failure.”

About the SOLOIST and SCORED Studies

SOLOIST was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 1,222 patients with type 2 diabetes who had recently been hospitalized for worsening heart failure. The primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo.

SCORED was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 10,584 patients with type 2 diabetes, chronic kidney disease with eGFR of 25 to 60 ml per minute per 1.73 m² of body-surface area, and risks for cardiovascular disease. The primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo.

Both SOLOIST and SCORED achieved their respective primary endpoints, with overall tolerability similar to placebo across both trials. Results from both studies were presented at the Late-Breaking Science Session of the American Heart Association (AHA) Scientific Sessions 2020 and simultaneously published in The New England Journal of Medicine (NEJM) in two separate articles titled: “Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure” and “Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease.”

About Sotagliflozin

Discovered using Lexicon’s 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.

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

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ⁱ Jankowski J, Floege J, Fliser D, Böhm M, Marx N. Cardiovascular Disease in Chronic Kidney Disease: Pathophysiological Insights and Therapeutic Options. Circulation. 2021 Mar 16;143(11):1157-1172. doi: 10.1161/CIRCULATIONAHA.120.050686. Epub 2021 Mar 15. PMID: 33720773; PMCID: PMC7969169.

https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.120.050686

ⁱⁱ H-H Parving, JB Lewis, et al. Prevalence and risk factors for microalbuminuria in a referred cohort of type II diabetic patients: A global perspective. Kidney International. 2006; 69, 2057–2063. doi:10.1038/sj.ki.5000377.

https://pubmed.ncbi.nlm.nih.gov/16612330/