Lexicon's sotagliflozin meets Phase III endpoint in type 1 diabetes

US biopharma company Lexicon Pharmaceuticals (Nasdaq: LXRX) today revealed that the pivotal inTandem1 Phase III 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.

Lexicon's shares jumped 19.11% to $18.24 by mid-morning following the news.

Top-line results from the Phase III 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.