Phase III trial of ITCA 650 (continuous subcutaneous exenatide) in type 2 diabetes meets all endpoints- Intarcia Therapeutics

Intarcia Therapeutic has announced positive top-line results from its 52-week Phase III FREEDOM-2 clinical trial to determine the comparative efficacy of ITCA 650 (continuous subcutaneous delivery of exenatide) to Merck's Januvia (sitagliptin) in reducing HbA1c in patients with type 2 diabetes following a year of treatment. All patients were on background metformin monotherapy. ITCA 650 is an injection-free GLP-1 receptor agonist in development that continuously delivers exenatide with just once or twice-yearly dosing via a small matchstick-size subdermally placed osmotic mini-pump.

In the FREEDOM-2 trial, ITCA 650 met all primary and secondary endpoints, demonstrating superiority over sitagliptin at every measured time point through and including week 52 endpoints for reduction in HbA1c and reduction in body weight (BW). ITCA 650 is not yet being investigated for the management of obesity. Results show that significantly more patients on ITCA 650 (60 µg) versus sitagliptin 100mg achieved the secondary composite endpoint combining glucose reductions of > 0.5% and weight reductions of 2 kg or greater. In addition, ITCA 650 results were superior vs sitagliptin 100mg. Significantly more patients on ITCA 650 (60 µg) achieved the ADA-recommended HbA1c target of < 7.0% versus sitagliptin 100mg and ITCA 650 results were superior vs sitagliptin 100mg. Full details of the trial results will be submitted for publication.

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.