ITCA 650 subcutaneous exenatide meets primary and secondary endpoints in Phase III trial for type 2 diabetes- Intarcia Therapeutics

Intarcia Therapeutics announced top-line results from its more than 4,000 patient Cardiovascular Safety Study (FREEDOM-CVO trial) of ITCA 650 subcutaneous exenatide in type 2 diabetes, clearing the last major clinical hurdle in the global FREEDOM Phase III Clinical Trial Program that started in early 2013. Regulatory filing in the U.S. is targeted for end of 3Q, 2016. The FREEDOM-CVO Phase III safety trial mets its primary and secondary endpoints by demonstrating FDA required non-inferiority for pre-approval cardiovascular (CV) safety. Final data to be published and presented at major future medical meeting.

Comment: the important characteristic of ITCA 650 is that the product requires only a once a year implantation which is seen as a solution to patient compliance well ahead of its competitors.Note also that Servier Laboratories have marketing rights outside the USA.