Lexicon Reports Additional Positive Data from Pivotal InTandem1 Phase 3 Study for Sotagliflozin

Lexicon Pharmaceuticals announced additional positive data from the Phase 3 inTandem1 study. It was previously announced that both doses of sotagliflozin achieved the primary endpoint of the inTandem1 study, showing statistically significant reductions in A1C at 24 weeks in patients with type 1 diabetes on a background of optimized insulin. New key findings include meaningful benefit of sotagliflozin on body weight in patients with type 1 diabetes and on systolic blood pressure in hypertensive patients with type 1 diabetes. In addition, the company announced achievement of important secondary endpoints including net benefit, bolus insulin use, fasting plasma glucose and patient reported outcomes.

In a key secondary endpoint, patients taking sotagliflozin experienced a mean reduction from baseline in body weight after 24 weeks of treatment of 1.6 kg for the 200mg dose and 2.7 kg for the 400mg dose, compared to a mean body weight gain of 0.8 kg for patients on placebo (p<0.001 for both doses). Sustained effects on body weight were also seen at 52 weeks.

Systolic blood pressure (SBP) in the subset of type 1 diabetic patients in the study with baseline hypertension (SBP ≥130 mmHg) was reduced by 9.9 mmHg and 11.0 mmHg at week 12 when treated with 200 mg and 400 mg of sotagliflozin, respectively, compared to a reduction of 4.4 mmHg on placebo (p=0.017 and p=0.003 for the 200 mg and 400 mg doses, respectively).

Notably, the outcome on every secondary endpoint favored sotagliflozin over placebo, with results for the 400 mg dose having achieved statistical significance for all six secondary endpoints included:

• The proportion of patients achieving A1C <7.0% with no episode of severe hypoglycemia or diabetic ketoacidosis ("net benefit")
• Body weight
• Bolus insulin use
• Fasting plasma glucose
• Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score
• 2-item Diabetes Distress Screening Scale (DDS2) questionnaire score