THE WOODLANDS, Texas, June 24, 2018 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq:LXRX), today announced positive 52-week results from the Phase 3 inTandem1 study for sotagliflozin in adults with type 1 diabetes. In the North American study, administration of sotagliflozin 200 mg or 400 mg in combination with maximally tolerated standard of care insulin therapy resulted in statistically significant reductions in A1C levels and weight compared to optimized insulin alone. A lower incidence of severe hypoglycemia was observed with sotagliflozin 200 mg and 400 mg compared to placebo.
The results were unveiled today as part of the symposium of the 78th Scientific Sessions of the American Diabetes Association (ADA) in Orlando, FL, titled “Clinical Trials in Type 1 Diabetes” and were published in Diabetes Care, the ADA’s peer-reviewed research journal dedicated to diabetes treatment and prevention. The online publication, “Sotagliflozin in Combination With Optimized Insulin Therapy in Adults With Type 1 Diabetes: The North American inTandem1 Study,” may be accessed here: https://doi.org/10.2337/dc18-0343.
New 52-week findings from inTandem1, a 793-patient double-blind, placebo-controlled Phase 3 study, demonstrated that sotagliflozin, in combination with insulin, significantly reduced A1C, weight, total daily insulin dose and fasting plasma glucose (FPG) compared to placebo, with a lower incidence of severe hypoglycemia. In addition, more patients taking sotagliflozin in combination with optimized insulin achieved 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 6.5% of patients in each of the sotagliflozin 200 mg and 400 mg cohorts reported episodes of severe hypoglycemia compared to 9.7% of patients on placebo. A total of 3.4% of patients on sotagliflozin 200 mg and 4.2% of patients on sotagliflozin 400 mg experienced DKA compared to 0.4% of patients on placebo. Study authors indicate that the DKA risk could potentially be mitigated with patient education and monitoring.
The inTandem1 study was a double-blind, placebo-controlled, 75-site, North American 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 793 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=268), 200 mg of sotagliflozin (n=263) and 400 mg of sotagliflozin (n=262), 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 A1C, weight, bolus insulin and FPG changes at Week 52, 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.
“These results presented today provide evidence for the long-term efficacy and safety of sotagliflozin and highlight the need for new treatment options for people living with type 1 diabetes,” said lead study investigator Dr. John Buse, MD, PhD, director of the Diabetes Center, director of the NC Translational and Clinical Sciences Institute, and executive associate dean for clinical research at the University of North Carolina School of Medicine in Chapel Hill. “Most patients do not reach their treatment goals on insulin alone and management of disease burden remains challenging. If approved, sotagliflozin, in combination with insulin, may be an important treatment option for patients with type 1 diabetes.”
“We are extremely pleased to see that the clinical effects of sotagliflozin on blood sugar and weight for adults with type 1 diabetes were sustained through one year of treatment,” said Pablo Lapuerta, MD, executive vice president and chief medical officer of Lexicon. “Importantly, sotagliflozin, in combination with insulin, helped patients achieve their target glucose levels while also experiencing a lower incidence of severe hypoglycemia. There remains a need for oral therapeutic agents used in conjunction with insulin to improve the treatment options for people with type 1 diabetes and we believe sotagliflozin can potentially meet this need.”
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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