Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) announced that the pivotal in Tandem1 Phase 3 clinical trial of sotagliflozin met its primary endpoint, showing a statistically significant reduction in A1C at 24 weeks in patients with type 1 diabetes on a background of optimized insulin.

Top-line results from the Phase 3 study showed that patients treated with sotagliflozin had a mean A1C reduction from baseline of 0.43% on 200mg once daily sotagliflozin dose (p<0.001) and a reduction of 0.49% on 400mg once daily sotagliflozin dose (p<0.001) as compared to a reduction of 0.08% on placebo after 24 weeks of treatment, meeting the study’s primary endpoint. This statistically significant and clinically meaningful improvement in A1C for both doses of sotagliflozin was achieved without an increase in severe hypoglycemia, one of the most prevalent serious health challenges in type 1 diabetes, which was seen less frequently in both treatment arms than placebo.

“We are extremely pleased with these top-line results and the potential long-term benefits that sotagliflozin may bring to people with type 1 diabetes,” said Lexicon President and Chief Executive Officer Lonnel Coats. “We believe these results provide evidence that sotagliflozin, with its novel dual inhibition of both SGLT-1 and SGLT-2, is particularly well suited to help these individuals achieve better A1C levels without increasing and possibly reducing the risk of severe hypoglycemia.”

“Our companies are working together to develop this compound for the treatment of type 1 and type 2 diabetes,” said Jorge Insuasty, Senior Vice President, Head of Global Development, Sanofi. “These top-line results highlight potential benefits of sotagliflozin when treating adults with type 1 diabetes. We congratulate our partners on this positive outcome and look forward to further exploring this compound for the treatment of adults with type 2 diabetes when Sanofi begins the Phase 3 program later this year.”

“The inTandem1 study is part of the largest Phase 3 program for an oral anti-diabetic agent in type 1 diabetes to date,” said Anne Peters, M.D., Professor of Medicine at the Keck School of Medicine of USC, Director of the USC Clinical Diabetes Programs and Chairman of the Sotagliflozin Type 1 Diabetes Steering Committee. “Sotagliflozin demonstrated compelling, significant and clinically meaningful A1C reduction with no increase in severe hypoglycemia and a slight risk of DKA. If approved, sotagliflozin could represent a significant addition to the current standard of care and potentially allow patients with type 1 diabetes to better manage their diabetes while on insulin.” (Original Source)

Shares of Lexicon Pharmaceuticals closed yesterday at $15.31, up $0.41 or 2.75%. LXRX has a 1-year high of $16.98 and a 1-year low of $7.65. The stock’s 50-day moving average is $15.49 and its 200-day moving average is $13.61.

On the ratings front, Lexicon has been the subject of a number of recent research reports. In a report issued on August 11, Needham analyst Alan Carr reiterated a Buy rating on LXRX, with a price target of $21, which implies an upside of 37% from current levels. Separately, on August 4, Wedbush’s Liana Moussatos maintained a Buy rating on the stock and has a price target of $31.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Alan Carr and Liana Moussatos have a total average return of 10.9% and 6.2% respectively. Carr has a success rate of 47% and is ranked #247 out of 4147 analysts, while Moussatos has a success rate of 38% and is ranked #546.

Lexicon Pharmaceuticals, Inc. engages in discovery and development of breakthrough treatments for human disease. The company primarily focuses on the discovery of the functions and pharmaceutical utility of genes and the use of those gene function discoveries in the discovery and development of pharmaceutical products for the treatment of human disease. The company uses its proprietary gene knockout technologies and an integrated platform of advanced medical technologies to systematically study the physiological and behavioral functions in mice and assessed the utility of the proteins encoded by the corresponding human genes as potential drug targets. It has multiple programs in clinical development for diabetes, irritable bowel syndrome, carcinoid syndrome and other indications.