Vitae suffers another stinging setback as lead diabetes drug fails in PhII

Vitae CSO Richard Gregg

Vitae Pharmaceuticals has slammed into another setback. The small biotech's ($VTAE) lead drug, the diabetes therapy VTP-34072, failed the first leg of a mid-stage study executed by Boehringer Ingelheim.

The partners only unveiled topline data, but noted that one of two arms for patients on stable doses of metformin did not hit the primary endpoint on fasting plasma glucose. Another placebo-controlled monotherapy arm reports out later this year, and Vitae reports that the partners will use all of the data to determine how best to proceed.

The news didn't sit well with investors who bought into Vitae's IPO last fall, at least in part because of the potential of this drug. Vitae has touted its drug's potential to inhibit 11b hydroxysteroid dehydrogenase type 1, or 11b HSD1, the enzyme responsible for production of cortisol in tissues where active glucose metabolism takes place, including the liver and adipose, or fat, tissue. Vitae's shares plunged 41% when the market opened, but pared that down to a 14% loss by midmorning.

As of a year ago, Boehringer had handed over $74.2 million in its deal with Vitae. Another $272 million was still on the table when Vitae filed to go public last year. Vitae managed to raise $65 million in its IPO, but only after slashing the price to $8 a share. 

This isn't Vitae's first time to be punished for a setback. Last February its stock took a hit after Boehringer slammed the brakes on a Phase I study of their partnered BACE inhibitor for Alzheimer's. Investigators made the decision on the hold after observing skin rashes in patients enrolled in an early-stage dose-ranging study. That makes the setback on diabetes that much more painful today.

"The metabolically complex, overweight type 2 diabetic patient population is in need of novel mechanisms of action that can address their overall risk profile," said Dr. Richard Gregg, the CSO of Vitae, in a statement. "We are anxious to learn more about BI187004/VTP-34072 when the study is completed and fully analyzed."