Intarcia Announces CV Results Needed for FDA Approval of Diabetes Therapy Delivery

Intarcia Therapeutics announced Friday that it had met targets of a 3-year cardiovascular safety trial for its unique diabetes therapy system, 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 of ITCA 650, the matchstick-size device that continuously delivers microscopic doses of exenatide. Researchers say trial results show the device’s potential to be “transformational” in the care of type 2 diabetes, because it removes stumbling blocks for groups of high-risk patients with poor adherence and high medical costs.

The announcements, in a press release, said 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. 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.

Clinical trials have shown that use of ITCA 650 reduced glycated hemoglobin (A1C) after 39 weeks by 1.1% for patients taking a 40 mcg dose; those taking a 60 mcg dose with sulfonylurea (SU) saw their A1C drop 1.2% and those taking the 60 mcg dose without SU therapy saw a drop of 1.7%, compared with placebo. (Click here for results.)

Julio Rosenstock, MD, clinical professor of medicine at the University of Texas Southwestern Medical Center, told a packed session at the American Diabetes Association in June 2015 that the nature of the delivery device, which is placed under the skin and only replaced once or twice a year, ensures 100% adherence. Medication adherence in diabetes care is such a problem that health economists consider 80% adherence a “good” level.

“Completion of our FREEDOM-CVO safety trial is the most recent of our 4 consecutive and successful clinical milestones for Intarcia, marking the end of our large pivotal phase 3 trials required for regulatory submissions for ITCA 650,” Michelle Baron, MD, FACE, Intarcia’s chief medical officer, said in the statement.

“The FREEDOM phase 3 clinical trial program for ITCA 650 has come to close at an exciting and auspicious time in the GLP-1 receptor agonist category,” said Intarcia CEO Kurt Graves. He said that other trials are showing the drug class, glucagon-like peptide receptor agonist, may offer a protective cardiovascular benefit, something that has been of keen interest to the FDA in recent years.

“Against this backdrop and an accelerating growth trajectory and outlook for the GLP-1 class of medicines, we’re right where we wanted to be when we started this mission nearly 10 years ago,” he said.