New Secondary Analysis of Phase 3 Data Demonstrates Sotagliflozin Improves Time-In-Range (TIR) and Several Parameters of Glucose Control and Variability in Basal Insulin-Treated Type 2 Diabetes

Rhea-AI Summary

Lexicon Pharmaceuticals (Nasdaq: LXRX) announced positive results from the SOTA-INS CGM Phase 3 trial for sotagliflozin in type 2 diabetes (T2D) patients treated with basal insulin. The study showed that once-daily dosing of sotagliflozin 400 mg improved time-in-range (TIR) and several continuous glucose monitoring (CGM) parameters, including glucose variability. The 200 mg dose also showed positive trends.

Key findings include:

• Sotagliflozin 200 mg and 400 mg once daily TIR (15.3 and 15.9 hours, respectively) approached the American Diabetes Association's target of 17 hours
• Modest reductions in time-above-range (TAR) and mild increases in time-below-range (TBR) were observed

The results will be presented at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD) on September 12th, 2024.

Positive

• Sotagliflozin 400 mg improved time-in-range (TIR) and CGM parameters in T2D patients on basal insulin
• Both 200 mg and 400 mg doses approached ADA's TIR target of 17 hours
• Study results align with positive outcomes from previous T1D trials
• Data adds to evidence supporting the value of dual SGLT1 and SGLT2 inhibition

Negative

• Lexicon is not pursuing an indication to treat type 2 diabetes with sotagliflozin
• Mild increases in time-below-range (TBR) were observed

Study results aligned with positive clinical trial outcomes for type 1 diabetes treatment with sotagliflozin  

TIR measures approach target set by American Diabetes Association

Data to be presented at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain and online

THE WOODLANDS, Texas, Sept. 10, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that data from the SOTA-INS CGM Phase 3 randomized clinical trial demonstrated that once-daily dosing of sotagliflozin 400 mg improved time-in-range (TIR) and several continuous glucose monitoring (CGM) parameters, including glucose variability, in insulin-treated type 2 diabetes (T2D) patients. Researchers also observed positive trends with the once-daily dose of 200 mg. Study findings will be presented September 12^th at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain and online.

The objective of the SOTA-INS CGM study was to evaluate the effect of sotagliflozin on TIR as assessed by CGM in people with T2D. The primary sub-study endpoint was mean change in percentage of time spent within TIR (glucose 70-180 mg/dL [3.9-10.0 mmol/L]) over 24 hours for sotagliflozin 400 mg versus placebo.

The American Diabetes Association recommends a TIR target of at least 70% (17 hours) in people with type 1 diabetes (T1D) or T2D. In this study, sotagliflozin 200 mg and 400 mg once daily TIR (15.3 and 15.9 hours, respectively) approached the ADA target, with modest reductions in time-above-range (TAR) and mild increases in time-below-range (TBR).

Sotagliflozin has previously demonstrated glycemic efficacy and improvements in TIR as an adjunct to insulin therapy in people with T1D who participated in the inTandem clinical trial program.

Details of the data presentation are as follows: 

• Effect of Sotagliflozin, a Dual SGLT 1 and 2 Inhibitor, on Continuous Glucose Monitoring in Basal Insulin-Treated Type 2 Diabetes – an ePoster presentation, Thursday, September 12^th, 12:45p.m. CEST, IFEMA Madrid, Station 10 and online, presented by Julio Rosenstock, M.D., Senior Scientific Advisor for Velocity Clinical Research, Director of Velocity’s site at Medical City Dallas, and Clinical Professor of Medicine at the University of Texas Southwestern Medical Center, Dallas.
  

“We are encouraged by the observation of Dr. Rosenstock and his fellow researchers that sotagliflozin’s dual inhibition of SGLT2 and SGLT1 may offer an additional therapeutic option to improve glycemic control for people with type 2 diabetes on basal insulin,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. “While we are not pursuing an indication to treat people with type 2 diabetes, this study adds to the body of evidence supporting the incremental value of inhibiting SGLT1.”

About sotagliflozin
Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients.

About Lexicon Pharmaceuticals
Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, 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 disease safely and effectively. Lexicon has commercially launched one of these medicines, INPEFA® (sotagliflozin) in the United States, and has a pipeline of other promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, 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 commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of its other drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon’s growth and future operating results, discovery, development and commercialization 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 its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of 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 approved products and other 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, 2023, 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 Investor and Media Inquiries:
Lisa DeFrancesco
Lexicon Pharmaceuticals, Inc.
lexinvest@lexpharma.com

FAQ

What were the main results of the SOTA-INS CGM Phase 3 trial for sotagliflozin (LXRX)?

The trial showed that sotagliflozin 400 mg once daily improved time-in-range (TIR) and several continuous glucose monitoring (CGM) parameters in type 2 diabetes patients treated with basal insulin. Both 200 mg and 400 mg doses approached the ADA's TIR target of 17 hours.

When and where will the SOTA-INS CGM Phase 3 trial results for sotagliflozin (LXRX) be presented?

The results will be presented on September 12th, 2024, at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain and online.

What is the significance of the SOTA-INS CGM Phase 3 trial results for Lexicon Pharmaceuticals (LXRX)?

The results add to the body of evidence supporting the incremental value of inhibiting both SGLT1 and SGLT2 in diabetes treatment. However, Lexicon is not pursuing an indication to treat type 2 diabetes with sotagliflozin.

How does sotagliflozin (LXRX) differ from other diabetes medications?

Sotagliflozin is a dual inhibitor of SGLT1 and SGLT2, which may offer an additional therapeutic option to improve glycemic control for people with diabetes, as opposed to medications that only inhibit SGLT2.