The ITCA 650 device, which delivers tiny doses of exenatide, could be a game changer in solving the problem of medication adherence. An application for FDA approval is expected in the first half of 2016.
Intarcia Therapeutics Inc released topline results Tuesday for ITCA 650, the implantable device that can deliver up a year’s worth of exenatide, and said patients with type 2 diabetes mellitus (T2DM) in a phase 3 clinical trial experienced superior results than those treated with sitagliptin, marketed as Januvia.
Patients treated with 60 mcg of exenatide saw an average reduction in glycated hemoglobin (A1C) of 1.5%, compared with the average reduction of 0.8 % ( P < 0.001) for patients taking 100 mg of sitagliptin. The patients who were delivered exenatide, a widely used GLP-1 receptor agonist, also experienced greater weight loss, an average of 4 kg, compared with an average loss of 1.3 kg for the sitagliptin group.
The company also reported that more patients in the ITCA 650 group achieved the ADA-recommended target of < 7% A1C.
The trial phase 3 FREEDOM-2 trial involved 535 adult patients with T2DM who were treated for 52 weeks, with a 4-week post treatment follow-up period. All had an A1C of at least 7.5% but not greater than 10.5%. Patients were all treated on background metformin and were randomized 1:1 for treatment with either sitagliptin or with exenatide through the unique delivery system, in which a matchstick-like device is placed under the skin to continuously administer tiny doses of the drug, ensuring perfect adherence.
Intarcia is poised to file for a regulatory approval in the first half of 2016, according to the statement from the company.
“If approved, ITCA 650 would be the first and only GLP-1 receptor agonist to offer a viable alternative to regular, lifelong injections, and with once or twice yearly dosing it has the potential to enhance patient compliance, which has been a longstanding, unresolved problem and a major contributing cause of poor glycemic control over time,” said Robert R. Henry, MD, chief of the VA Endocrinology and Metabolism section and professor of medicine in resident at the University of California San Diego, and an investigator in the phase 3 trial.
The data, he said, leave little doubt about the value of the delivery system for tackling the vexing problem of medication adherence, which has been a huge obstacle to achieving glycemic control in certain patient populations.
ITCA 650’s performance head-to-head against sitagliptin is compelling in light of the drug’s worldwide sales of $6 billion, said Intarcia President and CEO Kurt Graves.
Sitagliptin, a DPP-4 inhibitor, scored a major victory earlier this year when it demonstrated no cardiovascular effects in the TECOS trial, especially relative to its closest competitor; topline results were released in late April and the full study was presented in June at the Scientific Sessions of the American Diabetes Association (ADA). But ITCA 650 was a star at the ADA sessions in its own right, with scores of visitors crowding the booth to watch demonstrations of how the tiny drug-fueled piston was inserted under the skin. A large crowd packed a conference session to hear promising results of the study at the 39-week mark.
While the company reported the weight loss results yesterday, it noted in its statement that ITCA 650 is not yet being investigated for management of obesity. Full data will be reported at an upcoming major medical meeting.