Benzinga | Jul 21, 2020 07:05AM EDT

Lexicon Pharmaceuticals Announces Topline Phase 3 Data From Four Phase 3 Sotagliflozin Studies In Type 2 Diabetes

THE WOODLANDS, Texas, July 21, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today announced topline data from four Phase 3 sotagliflozin studies in type 2 diabetes: SOTA-MONO, SOTA-SU, SOTA-GLIM and SOTA-INS. The final results of these studies will be preserved for upcoming medical congresses and publications.



"We are pleased with the evidence of robust A1C reduction and long-term safety in patients with type 2 diabetes demonstrated in these studies," said Pablo Lapuerta, MD., executive vice president and chief medical officer at Lexicon. "We look forward to presenting and publishing detailed results from these studies in the future."

All four Phase 3 sotagliflozin studies met their primary objectives of lowering A1C in patients with type 2 diabetes.

The observed safety profile of sotagliflozin in these studies was generally consistent with that of approved SGLT2 inhibitors. Diarrhea, an event consistent with gastrointestinal SGLT1 inhibition, was generally more common on sotagliflozin than placebo, although it was not a meaningful cause of treatment discontinuation. Genital mycotic infections were dose-related. The absolute increase in the incidence of genital mycotic infections over placebo ranged from 0% to 3.7% in studies of the 200 mg dose and from 3.2% to 6.3% in studies of the 400 mg dose. In one study, sotagliflozin showed less hypoglycemia than glimepiride, and in the other three studies, the incidences of hypoglycemia in patients on sotagliflozin were similar to those on placebo.

Lexicon does not intend to pursue any regulatory approvals of sotagliflozin for type 2 diabetes in the absence of a strategic partnership for the commercialization of sotagliflozin in such indication.