Intarcia Therapeutics anticipates filing for FDA approval at the end of the third quarter of 2016. At this year's ADA presentation, Julio Rosenstock, MD, said the insertion method for the novel therapy delivery device continues to improve.
A month after announcing it had cardiovascular results to seek FDA approval, Intarcia Therapeutics presented more data for ITCA 650, its novel diabetes therapy delivery system, at the 76th Scientific Sessions of the American Diabetes Association (ADA) in New Orleans, Louisiana.
Results from the FREEDOM-2 trial show that after 52 weeks, ITCA 650 continued to produce between glycemic control and more weight loss than sitagliptin, a popular therapy for type 2 diabetes (T2D).1
ITCA 650 delivers a continuous, microscopic dose of exenatide through a matchstick-size minipump, which is inserted beneath the skin in 1 of 4 areas on the stomach. Julio Rosenstock, MD, of the Dallas Diabetes and Endocrine Center, presented results Sunday from the randomized controlled trial involving 535 patients with uncontrolled T2D. All were taking metformin and had glycated hemoglobin of at least 7.5%, up to 10.5%. Patients were randomized to take either ITCA 650 with a daily dose of 60 mcg, or 100 mg of sitagliptin.1
Results showed that patients in the ITCA 650 arm had a significantly greater reduction in glycated hemoglobin (A1C), with this arm experiencing an average 1.5% reduction compared with 0.8% for the sitagliptin arm. Also, 61% of the ITCA 650 patients achieved an A1C of < 7%, the target recommended by ADA, compared with 42% for the sitagliptin arm.
Patients in the ITCA 650 arm lost an average of 8.8 pounds, compared with 2.8 pounds for the sitagliptin arm.
As he did at ADA 2015 in Boston, Rosenstock drew a packed room at 8 a.m. Sunday, with many clinicians anxious to hear about a delivery system that promises to eliminate barriers to adherence they encounter with some T2D patients. Rosenstock said the key word to keep in mind with ITCA 650 is “persistence.”
“Persistence means that people don’t just start the medication, but they stay on the medication,” he said. The ITCA 650 minipump is designed to be replaced at the 2 month-mark after a run-in with a lower dose; then patients move to a higher dose and the pump is replaced every 6 months. But Rosenstock said eventually the pump could be replaced once a year.
He said the exenatide was generally well-tolerated; discontinuations for nausea were in the “low single digits” according to a statement. Rosenstock said some patients would have nausea as they became acclimated to the drug and again when the dose increased, but not after that. Site reactions were consistent with minor surgery.
On Saturday, Intarcia’s exhibit drew visitors anxious to see how the insertion technique worked, and were invited to feel the minipump below the surface of the artificial “skin.” A poster presented Saturday showed that only a tiny portion of the more than 18,000 placements, involving 5200 patients (0.7%), have required a removal.2 During his presentation, Rosenstock said the insertion technique for minipump has improved steadily. “It is very superficial; it does not get too deep.”
Intarcia Therapeutics announced May 6, 2016, that it had met targets of a 3-year cardiovascular safety trial for ITCA 650, clearing the way for the company to file for FDA approval by the end of the third quarter of 2016. The company also announced an additional $75 million round of financing, which will allow growth needed for manufacturing the system.3
The company said at that time that the FREEDOM-CVO trial of 4000 patients was designed to show that the upper limit of the 95% confidence interval of the hazard ratio of major adverse cardiac events (MACE) for patients with standard diabetes care receiving ITCA 650 or placebo did not exceed 1.8. Full results of FREEDOM-CVO have not yet been presented.
The announcement said there were 160 strict MACE events, and that safety and tolerability of the ITCA 650 drug delivery system was consistent with earlier clinical trials as well as prior trials of exenatide and other GLP-1 receptor agonists.
In a statement today, Intarcia President and CEO Kurt Graves said the results show that ITCA 650 can be an early choice for patients with uncontrolled T2D. “Injectable GLP-1 receptor agonists aren’t typically used early in treatment with metformin because patients and doctors tend to reserve the choice of lifelong injections until other options fail,” he said. “If approved, ITCA 650 given just once or twice yearly can provide patients and doctors with a totally new way to deliver GLP-1 therapy much earlier with metformin.”
1. Rosenstock J, Denham D, Prabhakar R, Azeem R, Kjehms L, Baron M. Superior efficacy of ITCA 650 vs sitagliptin in uncontrolled type 2 diabetes on metformin: the FREEDOM 2 randomized, double-blind, 1-year study. Diabetes. 2016; 65(suppl1):183-OR.
2. Whitson A. ITCA 650: A novel therapeutic approach to treating type 2 diabetes (T2D). Diabetes. 2016; 65(suppl1):1027-P.
3. Intarcia announces successful cardiovascular safety results in Phase 3 FREEDOM —CVO trial for ITCA 650, an investigational therapy for type 2 diabetes [press release]. Boston, MA: Intarcia Therapeutics; June 12, 2016. http://www.intarcia.com/media/press-releases/2016-may-6-cardiovascular-safety.html