Lexicon Pharmaceuticals announced positive, top-line results from the Phase II clinical trial of its investigational drug LX4211 in Type 1 diabetes. The trial achieved the primary endpoint of reducing mealtime insulin in patients.
LX4211 is an oral, first in class dual inhibitor of sodium glucose transporters 1 and 2 (SGLT1 and SGLT2) designed to lower blood glucose levels through two insulin-dependent mechanisms of action. In the double-blind, placebo-controlled, 28-day study, the drug reduced total daily mealtime bolus insulin dose by 32 percent compared with 6 percent for placebo. The trial also met secondary endpoints including glycemic control.
Arthur Sands, Lexicon's president and CEO, said, “The results from this study provide a clear demonstration of proof-of-concept of LX4211 as an oral, investigational new drug for type 1 diabetes complementing insulin therapy. The magnitude of improved glycemic control by several measures, including HbA1c in only four weeks, and lower insulin requirements are highly encouraging and support the progression of LX4211 into late-stage development for type 1 diabetes.”
Type 1 diabetes affects more than one million people in the U.S., children and adults alike. T1D is an autoimmune disease characterized by the inability to produce the hormone insulin. This is caused by the immune system targeting and destroying the insulin-producing cells in the pancreas. Lexicon’s LX 4211 is designed to delay the absorption of glucose in the gastrointestinal tract and enhance glucose excretion in the kidney to allow improved glucose control and reduced insulin doses.
Pablo Lapuerta, Lexicon's CMO, said, “An oral agent benefiting patients with type 1 diabetes through both substantial improvements in glucose control and significant reduction in the use of insulin with no increase in hypoglycemia is both new and clinically meaningful. These results provide a strong rationale for demonstrating the effectiveness of LX4211 as an adjunct to insulin in Type 1 diabetes in a longer-term Phase 3 program.”