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Boehringer and Vitae Pharma drug fails in mid-stage trial

Published on 01/07/15 at 09:22am
BI building
Image: Boehringer Ingelheim GmbH

A pipeline diabetes drug co-developed by Vitae Pharma and German giants Boehringer Ingelheim has failed to show benefits in a Phase II trial.

Pennsylvania-based Vitae Pharma said the proof-of-concept study, which looked at the investigational diabetes treatment BI187004/VTP-34072 in combination with metformin, failed to reach its primary endpoint – reducing fasting blood sugar levels.

The study had looked at BI187004/VTP-34072, a 11β HSD1 (or 11β-hydroxysteroid dehydrogenase type 1) inhibitor, and the standard first-line diabetes treatment metformin, over a 28-day study period in overweight people with type 2 diabetes.

However Vitae admitted that the change in fasting plasma glucose in people in the metformin arm of the study did not reach clinical significance. Data from the placebo-controlled monotherapy arm of the trial, which is still ongoing, is due to be reported later this year the company added.

BI187004/VTP-34072 was discovered by Vitae and is currently being developed by Boehringer, which is looking to bolster its offering in type 2 diabetes, along with Jardiance (empagliflozin) and Glyxambi (empagliflozin/linagliptin), among others. BI187004/VTP-34072 works by targeting an enzyme that produces the hormone cortisol, which increases blood sugar and helps to break down fat.

"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, chief scientific officer at Vitae. "We are anxious to learn more about BI187004/VTP-34072 when the study is completed and fully analysed."

Earlier this year Vitae was forced to put trials of its investigational drug for Alzheimer’s disease, called BI 1181181, on hold after Boehinger – which also partnered with the biotech firm to develop the drug – decided to further investigate skin reactions observed in some people on during the trial.

Analysts predicted Vitae will also shelve its development plans for the diabetes drug. Speaking to Reuters, Wedbush analyst Liana Moussatos says she does not expect the drug to continue being tested unless the monotherapy trial had ‘spectacular results’.

Lilian Anekwe

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