Lexicon sotagliflozin meets primary endpoint in four Phase 3 studies

Lexicon Pharmaceuticals (NASDAQ:LXRX) reported topline data from four Phase 3 studies, each of which demonstrated that sotagliflozin significantly reduced A1C levels in patients with Type 2 diabetes (T2D).

Sotagliflozin is an oral dual inhibitor of sodium-glucose co-transporter types 1 and 2, which are responsible for glucose absorption in the gastrointestinal tract and kidneys, respectively.

The four placebo-controlled Phase 3 studies enrolled at total of 2,431 T2D patients. The Phase 3 SOTA-MONO and SOTA-GLIM studies demonstrated that sotagliflozin is superior to placebo alone and is non-inferior to glimepiride, respectively. 

The Phase 3 SOTA-INS and SOTA-SU studies demonstrated that sotagliflozin significantly reduced A1C levels compared with sulfonylurea alone or in combination with metformin; and compared with basal insulin alone or in addition to oral antidiabetic agents, respectively.

The company noted that it does not intend to pursue any regulatory approvals of sotagliflozin for T2D in the absence of a strategic commercialization partnership.

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