Lexicon's sotagliflozin increases risk of ketoacidosis in Phase III
Lexicon Pharmaceuticals Inc. (NASDAQ:LXRX) was off $0.98 to $13.76 on Wednesday after reporting that sotagliflozin (SAR439954) increased the risk of diabetic ketoacidosis (DKA) in the Phase III inTandem3 trial to treat Type I diabetes, which met its primary endpoint in June. The company said partner Sanofi (Euronext:SAN; NYSE:SNY) plans to submit global regulatory applications for the product to treat Type I diabetes next half (see BioCentury Extra, June 9).
In inTandem3, the rate of DKA in patients who received sotagliflozin plus insulin therapy for 24 weeks was 3% vs. 0.6% in patients who received placebo plus insulin. Lexicon said the imbalance in the rate of DKA was even greater in sotagliflozin-treated patients who used an insulin pump compared to controls (4.4% vs. 0.7%). Of the 1,402 patients enrolled in the trial, 555 (39%) received their insulin via a pump...