BioCentury
ARTICLE | Clinical News

BHV, Islet report Phase IIb data for SGLT2 inhibitor

April 16, 2014 11:44 PM UTC

BHV Pharma Inc. (Research Triangle Park, N.C.) and Islet Sciences Inc. (OTCBB:ISLT) reported data on Wednesday from a pair of double-blind, dose-ranging Phase IIb trials evaluating remogliflozin etabonate ( BHV091009) in treatment-naïve patients with Type II diabetes. In the first trial, all doses of twice-daily remogliflozin reduced HbA1c from baseline to week 12, the primary endpoint (reductions of 1-1.4%, p<0.001 for the dose response). In the second trial, once-daily remogliflozin at doses above the lowest dose tested reduced HbA1c from baseline to week 12 (reductions of 0.5-0.8%, p<0.047 for the dose response). Data from both trials will be presented at the American Diabetes Association meeting in June.

BHV and Islet Sciences have developed a once-daily formulation of remogliflozin designed to maintain the efficacy of twice-daily dosing and the safety of once-daily dosing. The companies could not be reached for next steps with the new formulation. Remogliflozin is also in Phase II testing to treat non-alcoholic steatohepatitis (NASH). ...