Late-Stage Diabetes Study Sets the Stage for Lexicon Pharma

Lexicon Pharmaceuticals Inc. (NASDAQ: LXRX) shares surged on Tuesday after the company announced positive topline data for its late-stage studies in type 2 diabetes. Overall, all the studies met their primary endpoints.

In terms of the specifics, the topline data comes from four Phase 3 sotagliflozin studies in type 2 diabetes: SOTA-MONO, SOTA-SU, SOTA-GLIM and SOTA-INS. The company was quick to note that the final results of these studies will be preserved for upcoming medical congresses and publications.

Again 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.

In terms of treatment related effects, diarrhea, which is 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 0.0% to 3.7% in studies of the 200 mg dose and from 3.2% to 6.3% in studies of the 400 mg dose.

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Additionally, 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.

Looking ahead, the company 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.

Lexicon Pharma stock traded up about 11% on Tuesday to $2.34, in a 52-week range of $1.13 to $5.76. The consensus price target is $4.70.

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