Vitae Pharma’ Diabetes Drug Fails Mid-Stage Trial, the Second Drug in Less Than Six Months to Fail

Vitae Pharmaceuticals’ Diabetes Drug Fails Mid-Stage Trial, the Second Drug in Less Than Six Months to Fail
June 29, 2015
By Alex Keown, BioSpace.com Breaking News Staff

FORT WASHINGTON, Pa. – A diabetes drug being developed by Vitae Pharmaceuticals, Inc. failed to reduce blood sugar levels in patients in a mid-stage clinical trial, the company announced this morning.

The company’s stock fell nearly 13 percent in response to the news. The stock was trading at $13.09 this morning, down from $14.18 per share.

The experimental drug, VTP-34072, being co-developed by Boehringer Ingelheim, was being tested as an add-on to metformin, a common diabetes therapy, to treat type 2 diabetes in overweight patients. VTP-34072 is being studied for the treatment of type 2 diabetes and metabolic syndrome, and is Vitae’s most advanced product candidate. The drug was being tested over a 28 day period, but it failed to meet the endpoints of the trial. Additional data from the placebo-controlled monotherapy arm of the trial, which is ongoing, are expected to be reported later this year. Richard Gregg, the chief scientific officer of Vitae, said he was anxious to learn more about the company’s lead product after all the data had been analyzed.

“The metabolically complex, overweight type 2 diabetic patient population is in need of novel mechanisms of action that can address their overall risk profile,” Gregg said in a statement.

In earlier clinical trials VTP-34072 was shown to have had a positive impact on multiple cardiovascular and metabolic risk factors associated with metabolic syndrome.

When all data is available Boehringer Ingelheim will determine the next steps for the experimental drug, the company said this morning in a statement.

However, some analysts predict there will not be further studies of the drug. Wedbush analyst Liana Moussatos told Reuters she did not expect the drug to continue being tested unless the monotherapy trial had "spectacular results".

There were approximately 30 million people in the United States diagnosed with Type2 diabetes in 2015, according to the American Diabetes Association. It is expected up to 9 million more Americans are undiagnosed. If the present trends continue, as many as one in three American adults are expected to have type 2 diabetes by 2050. More than 200,000 people die each year from diabetic complications, according to data compiled by the association. Patients with metabolic syndrome, which affects approximately 85 percent of patients with type 2 diabetes, are characterized by being overweight and having elevated glucose, blood pressure, cholesterol and triglycerides, while having decreased levels of HDL-C or “good cholesterol.”

The economic cost of diagnosed type 2 diabetes in the United States was estimated to be $245 billion in 2012 and, of that, approximately $9.6 billion was spent on type 2 diabetes drugs, including DiaBeta, Glynase, Glucotrol and Amaryl.

The failure of VTP-34072 comes only a few months after Vitae had to put its Alzheimer’s disease treatment on hold for safety evaluations. That drug, BI 1181181, was also being co-developed by Boehringer Ingelheim. The drug was put on hold after patients in an early clinical trial reported skin reactions to the drug.


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