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Last Update: 25-Jun-12 09:38 ET
Lexion Pharma shares following positive results of Phase2B trial
Lexicon Pharma (LXRX $1.95 +0.04) announced that LX4211, an investigational, oral, dual inhibitor of sodium glucose transporters 1 and 2, showed substantial, dose-dependent, statistically-significant reductions in hemoglobin A1c in a Phase 2b trial in patients diagnosed with poorly-controlled type 2 diabetes who were concurrently treated with metformin, an established diabetes therapy. LX4211 treatment also produced significant reductions in body weight and blood pressure. Importantly, LX4211 treatment had a favorable safety profile and was well tolerated in the study. Lexicon has previously demonstrated that SGLT1 inhibition by LX4211 increases GLP-1 and PYY, GI hormones associated with glycemic control and appetite. The primary endpoint of the study was the change in HbA1C, a measure of glycemic control, from baseline to week 12. LX4211 was administered at doses of 75 mg QD, 200 mg QD, 200 mg BID and 400 mg QD. Top-line results showed that patients in the LX4211 treatment arms had mean HbA1C reductions from baseline of 0.43, 0.52, 0.79 and 0.95 percent, respectively (p<0.001 for all treatment arms). In patients randomized to placebo, HbA1C decreased by 0.09 percent. Adverse events were generally mild to moderate, and the overall incidence of adverse events with LX4211 was similar to placebo. There were four serious adverse events, none attributed to treatment, which were equally distributed across treatment groups and placebo. Importantly, there were no hypoglycemic events reported. "We are targeting Phase 3 initiation for the first half of 2013," said Dr. Pablo Lapuerta, chief medical officer at Lexicon. "Further development of LX4211 in type 2 diabetes will focus on demonstrating long-term benefits in glycemic and metabolic parameters and reduction in cardiovascular risk."
