Lexicon slides after NEJM publishes diabetes study results

Lexicon Pharmaceuticals after lower after the company announced earlier that the New England Journal of Medicine, or NEJM, published the results of the Phase 3 inTandem3 study of sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor, for the treatment of patients with type 1 diabetes on any background insulin therapy. The data were published online today in conjunction with presentation of these data at the European Association for the Study of Diabetes, or EASD, annual meeting. The study met its primary endpoint with statistical significance, demonstrating the superiority of sotagliflozin 400 mg compared to placebo in the proportion of patients with A1C less than7.0% at Week 24 and no episode of severe hypoglycemia and no episode of DKA after randomization. The responder rate for patients on sotagliflozin was approximately twice the rate as compared to placebo. The difference compared to placebo for patients treated with sotagliflozin was 13.4%, the company reported. The outcome on every secondary endpoint achieved statistical significance favoring sotagliflozin over placebo, including change from baseline in A1C, body weight, systolic blood pressure in patients with baseline SBP greater than or equal to130 mm Hg and bolus insulin. "Sotagliflozin demonstrated a generally well tolerated safety profile during a 24-week treatment period, with rates of treatment-emergent adverse events, serious adverse events, and discontinuations due to adverse events that were consistent with rates seen in two prior pivotal Phase 3 studies," Lexicon said. Lonnel Coats, Lexicon's president and CEO, added, "As we remain committed to advancing the science in diabetes and bringing innovative therapies to patients to help improve outcomes and ease the burden of managing their diabetes, we look forward to Sanofi's filing for global regulatory approval for type 1 diabetes in the first half of 2018." In midday trading, Lexicon shares have slid $1.39, or 9.46%, to $13.35.