The Woodlands, Texas, December 20, 2019 - Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced topline data from the Phase 3 SOTA-EMPA study for sotagliflozin (Zynquista™) in type 2 diabetes. The topline results are as follows:
- Sotagliflozin 400 mg achieved the primary endpoint of superiority on A1C reduction versus placebo at Week 26 in patients with type 2 diabetes who have inadequate glycemic control on a dipeptidyl peptidase 4 inhibitor (DPP4i) with or without metformin.
- Sotagliflozin 400 mg also achieved the key secondary endpoint of noninferiority versus empagliflozin on A1C reduction from baseline at Week 26.
- Sotagliflozin was generally well tolerated with safety results comparable to previously reported results.
The full results of SOTA-EMPA, the fourth of nine core Phase 3 studies in the sotagliflozin type 2 diabetes program, will be presented at future medical conferences.
“We are pleased that today’s results demonstrate sotagliflozin achieved a clinical profile comparable to the efficacy of empagliflozin and a safety profile consistent with previously reported results,” said Pablo Lapuerta, M.D., executive vice president and chief medical officer at Lexicon. “We look forward to the release of topline data from the remainder of the core Phase 3 sotagliflozin studies in type 2 diabetes in early 2020.”
SOTA-EMPA is a Phase 3, multicenter, 2:2:1 randomized, double-blind, placebo- and active-controlled, parallel-group study evaluating the efficacy and safety of sotagliflozin 400 mg compared to empagliflozin 25 mg and placebo in approximately 700 subjects with type 2 diabetes who have inadequate glycemic control on DPP4i with or without metformin.
The primary endpoint of the study is superiority of sotagliflozin 400 mg versus placebo on A1C reduction at Week 26 in patients with type 2 diabetes who have inadequate glycemic control on a DPP4i with or without metformin and a key secondary endpoint at Week 26 is noninferiority of sotagliflozin 400 mg versus empagliflozin on A1C reduction from baseline.
About Zynquista (sotagliflozin)
Discovered using Lexicon’s unique approach to gene science, Zynquista 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. Zynquista 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. Outside of such approval, Zynquista is investigational and has not been approved by any other regulatory authority for type 1 or type 2 diabetes.
About Lexicon Pharmaceuticals
Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking statements” relating to Lexicon’s clinical development of 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 Lexicon’s ability to meet its capital requirements, successfully commercialize XERMELO, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, 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, 2018, 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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