LXRX - Earlier this month, Lexicon announced positive top-line results in a Phase 2 clinical trial of LX4211, a dual inhibitor of sodium-glucose transporters 1 and 2, in patients with type 1 diabetes. LX4211 achieved the primary endpoint of reducing mealtime insulin use as well as several secondary endpoints, including improved glycemic control. In the placebo-controlled, double-blind, 28-day study, LX4211 reduced the total daily mealtime bolus insulin dose by 32% compared to 6% for placebo (p=0.007), while significantly improving glycemic control with a mean HbA1c reduction of 0.55% in the LX4211-treated group compared to a reduction of only 0.06% with placebo (p=0.002). These results were accompanied by significant improvement in the time spent in a target glucose range of 70-180 mg/dl, a significant reduction in time in hyperglycemic range, and no increase in hypoglycemia. Multiple measures indicated that LX4211 treatment resulted in reduced variability in blood glucose levels. Overall, LX4211 was well tolerated with no discontinuations of study medication due to adverse events. Lexicon plans to meet with the FDA to discuss the potential advancement of LX4211 into Phase 3 development for type 1 diabetes.
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