Exenatide continuous subcutaneous delivery met clinical endpoints in phase 3 trials

Exenatide delivered continuously once- or twice-yearly via an investigational matchstick-sized, subcutaneous, miniature osmotic pump designed by Intarcia Therapeutics, Inc. met HbA1c and weight reduction endpoints in two phase 3 trials, according to a press release.

The biopharmaceutical company announced it will submit the findings from both 9-month trials of the ITCA 650 therapy in patients with type 2 diabetes — FREEDOM-1 and FREEDOM-1 HBL (High Baseline) — for presentation at the annual American Diabetes Association meeting in June 2015.

“These new data indicate clearly that the ITCA 650 method of delivery provides an uninterrupted, smooth and continuous dose that assures adherence without the need for patient action or behavior modification, which we all know is extremely challenging for many patients,” Robert Henry, MD, of the University of California, San Diego, said in the release.

The placebo-controlled, double-blind FREEDOM-1 trial tested efficacy and safety of ITCA 650 compared with placebo. At daily doses of 40 mcg and 60 mcg, the therapy demonstrated superiority vs. placebo and met all clinical endpoints; pre-specified sub-group analyses showed improvement in hyperglycemia across a range of patients and oral diabetes medications.

Intarcia concurrently conducted the FREEDOM-1 HBL open-label trial in patients with baseline HbA1c from 10% to 12%. This group, all treated with a 60 mcg dose of ITCA 650, demonstrated a 3.4% sustained HbA1c decrease; further, 25% of patients on the therapy reached an HbA1c <7%.

The gastrointestinal tolerability profile in both studies showed nausea rates in the low single digits, as well as a low single-digit discontinuation rate for nausea.

If approved, ITCA 650 would be the first glucagon-like peptide-1 therapy to deliver up to a full year of treatment in a single subcutaneous miniature pump, according to the release. The company is now developing 6- and 12-month pumps for ongoing and additional investigation.

“With continued success in the remaining phase 3 trials, we should have a real game-changing therapy available soon to help physicians to better manage this serious disease,” Henry said in the release. “We desperately need new innovations like ITCA 650 that have the potential to positively affect the treatment of this devastating and growing epidemic worldwide.”

Two global studies — FREEDOM-2 comparing ITCA 650 with sitagliptin (Januvia, Merck) in patients on metformin only, and FREEDOM-CVO Safety Study examining cardiovascular outcomes in patients on a variety of anti-diabetes therapies — are ongoing, according to the release.