Sotagliflozin, in Combination with Insulin, Significantly Decreased A1C Levels and Reduced Weight at 52 Weeks
Results Observed at 24 Weeks Persisted at 52 Weeks
The Woodlands, Texas, June 23, 2018 - Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced positive 52-week results from the Phase 3 inTandem2 study for sotagliflozin in adults with type 1 diabetes. In the European study, sotagliflozin 200 mg or 400 mg in combination with maximally tolerated standard of care insulin therapy demonstrated statistically significant reductions in A1C levels and weight compared to optimized insulin alone. A lower incidence of severe hypoglycemia was observed with sotagliflozin 400 mg compared to placebo. Improvements in certain elements of glycemic control beyond A1C were also observed, including fasting plasma glucose (FPG) and glycemic variability.
The results were unveiled today as part of a moderated poster discussion at the 78th Scientific Sessions of the American Diabetes Association (ADA) in Orlando, FL, titled “Clinical Outcomes with Oral Therapies” and were published in Diabetes Care, the ADA’s peer-reviewed research journal dedicated to diabetes treatment and prevention. The online publication, “A1C and Hypoglycemia Reductions at 24 and 52 Weeks With Sotagliflozin in Combination With Insulin in Adults With Type 1 Diabetes: The European inTandem2 Study”, may be accessed here: https://doi.org/10.2337/dc18-0342.
New 52-week findings from inTandem2, a 782-patient double-blind, placebo-controlled Phase 3 study, demonstrated that both doses of sotagliflozin, in combination with insulin, significantly reduced A1C, weight and total daily insulin dose. Positive effects of sotagliflozin on glycemic control and patient reported outcomes observed at 24 weeks persisted at 52 weeks. In addition, more patients taking sotagliflozin 200 mg or 400 mg in combination with optimized insulin achieved, with statistical significance, the combined goal of an average blood sugar level below the ADA-recommended target without severe hypoglycemia and without diabetic ketoacidosis (DKA), also referred to as net clinical benefit. A total of 5.0% of patients on sotagliflozin 200 mg and 2.3% of patients on sotagliflozin 400 mg reported episodes of severe hypoglycemia compared to 5.0% of patients on placebo. A total of 2.3% of patients on sotagliflozin 200 mg and 3.4% of patients on sotagliflozin 400 mg experienced DKA compared to 0.0% of patients on placebo. Study authors indicate that the DKA risk could potentially be mitigated with patient education and monitoring.
The inTandem2 study was a double-blind, placebo-controlled, 96-site, European Phase 3 trial that compared the safety and efficacy of two different doses of oral sotagliflozin, each used in addition to optimized insulin versus optimized insulin alone. A total of 782 adults with type 1 diabetes who used an insulin pump or were on multiple injection therapy were enrolled in the trial. The participants had A1C levels between 7.0 % and 11.0% prior to the study. After six weeks of insulin optimization, participants were randomized to one of three groups: placebo (n=258), 200 mg of sotagliflozin (n=261) and 400 mg of sotagliflozin (n=263), each taken once daily before the first meal of the day. The primary endpoint was change from baseline in A1C at Week 24. Secondary endpoints included weight, bolus insulin, FPG changes, patient-reported outcomes and net clinical benefit assessing the proportion of patients with A1C <7.0% without severe hypoglycemia or DKA. Results after 24 weeks of treatment were previously reported last year.
“In this study, patients treated with sotagliflozin demonstrated better long-term glycemic control than those on placebo, reinforcing the positive results observed in the entire sotagliflozin program,” stated lead study investigator Thomas Danne, MD, Head of the Diabetes Center at the Children’s Hospital on the Bult in Hannover, Germany. “As type 1 diabetes continues to be a global burden, today’s data support the use of sotagliflozin to help many patients reach and sustain their individual glycemic goals.”
“Today’s results underscore the positive long-term effects observed to date in clinical studies of sotagliflozin and its potential as an important therapeutic option for adults with type 1 diabetes to help improve their glycemic control,” said Pablo Lapuerta, MD, executive vice president and chief medical officer of Lexicon. “We remain committed to meeting patients’ needs to help manage their condition.”
Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an investigational 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.
Lexicon entered into a collaboration and license agreement with Sanofi in November 2015 under which Lexicon granted Sanofi an exclusive, worldwide (excluding Japan), royalty-bearing right and license to develop, manufacture and commercialize sotagliflozin. Lexicon is responsible for all clinical development activities relating to type 1 diabetes and has exercised an exclusive option to co-promote and have a significant role, in collaboration with Sanofi, in the commercialization of sotagliflozin for the treatment of type 1 diabetes in the U.S. Sanofi is responsible for all clinical development and commercialization of sotagliflozin for the treatment of type 2 diabetes worldwide (excluding Japan) and is solely responsible for the commercialization of sotagliflozin for the treatment of type 1 diabetes outside the U.S. (excluding Japan).
About Lexicon Pharmaceuticals
Lexicon is a fully integrated biopharmaceutical company that is applying a unique approach to gene science based on Nobel Prize-winning technology to discover and develop precise medicines for patients with serious, chronic conditions. Through its Genome5000™ program, Lexicon scientists have studied the role and function of nearly 5,000 genes over the last 20 years and have 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. In addition to its first commercial product, XERMELO® (telotristat ethyl), Lexicon has a pipeline of promising drug candidates in clinical and pre-clinical development in diabetes and metabolism and neuropathic pain. For additional information please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to Lexicon’s and its licensee’s clinical development of and regulatory filings for sotagliflozin and the potential therapeutic and commercial potential of sotagliflozin. 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 the risk that the FDA and other regulatory authorities may not grant regulatory approval of sotagliflozin in accordance with Lexicon’s currently anticipated timelines or at all, and the risk that such regulatory approvals, if granted, may have significant limitations on the approved use of sotagliflozin. As a result, sotagliflozin may never be successfully commercialized. Other risks include Lexicon’s ability to meet its capital requirements, successfully commercialize XERMELO (telotristat ethyl), successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of LX2761, 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, 2017, 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.
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