The Woodlands, Texas, June 13, 2020 - Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today presented six posters for ZynquistaTM (sotagliflozin) at the virtual 80th American Diabetes Association (ADA) Scientific Sessions including additional efficacy and safety data patients with type 2 diabetes and moderate and severe renal impairment.
Phase 3 CKD-3 Study
In the Phase 3, multicenter, randomized, double-blind, placebo-controlled CKD-3 study, sotagliflozin was tested for superiority versus placebo in reducing A1C after 26 weeks of treatment in patients with type 2 diabetes, inadequate glycemic control and moderate (CKD Stage 3) renal impairment.
The study met its primary endpoint, demonstrating that sotagliflozin 400 mg significantly reduced A1C in the entire population of patients with moderate renal impairment compared to placebo at Week 26. The difference in least squares (LS) mean change in A1C from baseline for patients treated with sotagliflozin 400 mg compared to placebo was -0.24% (p = 0.0021). The change in A1C from baseline was not statistically different in patients treated with sotagliflozin 200 mg compared to placebo (p = 0.2085).
The safety profile of sotagliflozin was generally similar to that of placebo. Incidences of symptomatic hypoglycemia (with documented blood glucose ≤70 mg/dL) were 20.4% on sotagliflozin 400 mg, 27.3% on sotagliflozin 200 mg, and 25.0% on placebo. The rates of symptomatic hypoglycemia (per 100 patient years of exposure) were 114.0 on sotagliflozin 400 mg, 140.5 on sotagliflozin 200 mg, and 175.4 on placebo.
Phase 3 CKD-4 Study
In the Phase 3, multicenter, randomized, double-blind, placebo-controlled CKD-4 study, sotagliflozin was tested for superiority versus placebo in reducing A1C after 26 weeks of treatment in patients with type 2 diabetes, inadequate glycemic control and severe (CKD Stage 4) renal impairment.
The study did not meet its primary endpoint of demonstrating superiority of sotagliflozin versus placebo on A1C reduction after 26 weeks of treatment in patients with type 2 diabetes, inadequate glycemic control and severe renal impairment compared to placebo. The placebo-adjusted difference in A1C from baseline for patients treated with sotagliflozin 400 mg compared to placebo was -0.29% (p = 0.0962) at week 26. For sotagliflozin 200 mg, the placebo-adjusted difference in A1C was 0.05% (p = 0.8124).
Several findings indicated clinically meaningful glycemic control over time was achieved with sotagliflozin 400 mg. From baseline to Week 52, the placebo-subtracted A1C reduction for sotagliflozin 400 mg was - 0.69% (95% confidence interval: -0.23, -1.15). At Week 52, achievement of A1C ≤ 7% was seen in 20.7% of patients on sotagliflozin 400 mg compared to 6.5% on placebo. Over 52 weeks, the incidence of rescue therapy to treat hyperglycemia was 7.6% on sotagliflozin 400 mg and 15.1% on placebo. Results were consistent with a dose related-response, as the 200 mg dose group at Week 52 had a placebo-subtracted A1C reduction of -0.32%, 19.6% of patients achieved A1C ≤ 7%, and 10.9% required rescue therapy.
The safety profile of sotagliflozin was generally similar to that of placebo. This was a population at high cardiovascular risk, and the incidences of major adverse cardiovascular events (myocardial infarction, stroke, and cardiovascular death) were 4.4% on sotagliflozin 400 mg, 1.1% on sotagliflozin 200 mg, and 11.9% on placebo. Incidences of symptomatic hypoglycemia (with documented blood glucose ≤70 mg/dL) were 27.8% on sotagliflozin 400 mg, 28.7% on sotagliflozin 200 mg and 35.5% on placebo, and the rates (per 100 patient years of exposure) were 171.6 on sotagliflozin 400 mg, 226.9 on sotagliflozin 200 mg, and 269.8 on placebo.
Additional poster presentations
- Effects of sotagliflozin added to insulin therapy on beta-hydroxybutyrate in patients with type 1 diabetes. Peters, D. et al.
- Efficacy and safety of sotagliflozin by baseline renal function in adults with type 1 diabetes. Handelsman, Y. et al.
- Balancing the risk of DKA and severe hypoglycemia with sotagliflozin in adults with type 1 diabetes. Pettus, J. et al.
- Impact of treatment with sotagliflozin on the incidence of severe hypoglycemia in patients with T1D. Pettus, J.
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.
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,” including statements relating to Lexicon’s long-term outlook on its business, including the clinical development of, the regulatory filings for, and the potential therapeutic and commercial potential of XERMELO (telotristat ethyl), Zynquista (sotagliflozin), and LX9211. 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, 2019, 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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