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

Intarcia Therapeutics has presented positive results from its FREEDOM-2 clinical trial with ITCA 650, an injection-free GLP-1 receptor agonist that provides consistent and continuous delivery of exenatide via an osmotic mini-pump that is placed under the skin for patients with type 2 diabetes. ITCA 650 demonstrated superior efficacy to Januvia in reducing HbA1c and body weight in patients with poorly controlled type 2 diabetes on metformin following one year of treatment. ITCA 650 met all primary and secondary trial endpoints.

In the study, significantly more patients on ITCA 650 60 mcg versus Januvia 100 mg achieved the ADA-recommended HbA1c target of below 7.0% (61% versus 42%). An even more dramatic difference occurred in the composite endpoint of HbA1c reductions of greater than or equal to 0.5% and weight reductions of 2 kg (4.4lbs) or greater (61% versus 28). Baseline characteristics collected for each participant prior to the trial were similar, with an average age of 55 years, HbA1c level of 8.6%, body mass index (BMI) of 32.6 kg/m2 and duration since type 2 diabetes diagnosis of 8.3 years. In patients treated with ITCA 650, rescue therapy was required in 15% of patients compared to 35% of patients treated with Januvia. Significantly greater reductions were seen with ITCA 650 compared to Januvia for both HbA1c and weight early after the initiation of treatment and persisted over the entire 52 weeks.

ITCA 650 60mcg also demonstrated a tolerability profile similar to the FREEDOM-1 placebo-controlled trial presented at ADA 2015. Discontinuations for nausea were in the low single digits over the full 12 months of treatment. The data was presented at the 76th Scientific Sessions of the American Diabetes Association.

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.