Lexicon Pharma Rockets on Late-Stage Diabetes Drug Data

Lexicon Pharma Rockets on Late-Stage Diabetes Drug Data September 9, 2016
By Alex Keown, BioSpace.com Breaking News Staff

THE WOODLANDS, Texas – Shares of Lexicon Pharmaceuticals are up more than 18 percent this morning after the company announced its Phase III Type 1 diabetes trial met its primary endpoint, showing significant improvement in blood sugar control.

Sotagliflozin is a dual inhibitor of sodium-glucose transporters 1 and 2 (SGLT-1 and SGLT-2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Results from the 793-patient Phase III trial showed sotagliflozin caused a “significant reduction” in A1C at 24 weeks in patients with type 1 diabetes on a background of optimized insulin, the company announced. 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, the company said. Two primary safety concerns for patients with type 1 diabetes are severe hypoglycemia and diabetic ketoacidosis. Patients enrolled in the trial were diagnosed with Type 1 diabetes and had treatments of an insulin pump or multiple daily injection therapy. The patients also had an A1C level entering the study between 7 and 11 percent, the company said.

Sotagliflozin has been shown in a Phase II study to improve glycemic control in people with type 1 diabetes while reducing their need for mealtime insulin.

"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 Lonnel Coats, Lexicon’s president and chief executive officer. "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."

Lexicon is developing sotagliflozin along with Sanofi. The two companies struck a $1.7 billion deal in November 2015, which gave the French company exclusive marketing rights to sotagliflozin.

In a statement, Jorge Insuasty, Sanofi ’s head of global development, hailed the results of the Phase III test and said the companies were also investigating sotagliflozin for the treatment of Type 2 diabetes as well. A Phase III study for that will be initiated by Sanofi later this year, Insuasty said.

Anne Peters, Director of the USC Clinical Diabetes Programs and chairman of the Sotagliflozin Type 1 Diabetes Steering Committee, also praised the Phase III trial results. She said if the FDA approve sotagliflozin for Type I diabetes, it would 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."

Shares of Lexicon hit a morning high of $21 before sliding back a bit to its current value of $17.76 per share as of 11:53 a.m.

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