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Intarcia Poised to Seek FDA Approval for ITCA 650 After Positive A1C, CV Results

Mary Caffrey
Officials say the company will file with FDA some time in the third quarter of 2016 to begin the approval process for the novel delivery system that brings a continuous, microscopic dose of exenatide to patients with type 2 diabetes.
This fall, Intarcia Therapeutics is expected to seek FDA approval for ITCA 650, a novel diabetes therapy delivery system that has gained notice at professional meetings for more than 2 years. Intarcia officials told Evidence-Based Diabetes Management that the filing will occur in the third quarter of 2016. This step will come after months of good news, which included positive topline results from a cardiovascular (CV) safety trial.

Next came findings presented at the June meeting of the American Diabetes Association (ADA), in New Orleans, which showed ITCA 650 produced better glycemic control and more weight loss than sitagliptin over 52 weeks.2

Some see ITCA 650 as a game changer, because the matchstick-size device that delivers a continuous, microscopic dose of exenatide solves a huge problem in diabetes care: medication adherence. ITCA 650’s minipump, which is inserted beneath the skin in 1 of 4 areas on the stomach, propels exenatide on its own and only requires the patient to be seen every 6 months to replace the pump.   To make this point, during the ADA sessions, Intarcia highlighted an analysis of data from the National Health and Nutrition Examination Survey, which show that only about 50% of diabetes patients achieve a glycated hemoglobin (A1C) goal of less than 7% with available therapies. The analysis found that poor adherence accounts for 75% of the drop-off in efficacy from clinical trials to real-world results.3

  Cardiovascular Safety Trial

 On May 6, 2016, Intarcia announced that it had met targets of a 3-year CV safety trial, which cleared the way for the company to seek FDA approval.1 Following an episode with rosiglitazone, regulators now require CV outcomes trials for all new diabetes and obesity therapies. Many of these “CVOTs” continue into the postmarketing period, but more recently some therapies have come to FDA with safety results in hand. (Sanofi’s lixisenatide gained approval with CV results already complete.4)

Also, in May, Intarcia announced $75 million in new financing, designed to ramp up production of ITCA 650 in anticipation of a global launch.1 At press time, Intarcia had not announced when the full results of the CV safety trial, FREEDOM-CVO, would be presented.

Clinical Findings at ADA

For the second straight year, attendees at ADA packed the room to hear Intarcia’s latest results. Julio Rosenstock, MD, of the Dallas Diabetes and Endocrine Center, presented results on June 12, 2016, from the randomized controlled trial involving 535 patients with uncontrolled type 2 diabetes (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.2

  Results showed that patients in the ITCA 650 arm had a significantly greater reduction in 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 less than 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.

The Key Word Is “Persistence”

  When presenting earlier findings at ADA in 2015, Rosenstock described the “transformational” possibilities of ITCA 650. This June, in New Orleans, he 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 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. 

  At the past 2 ADA meetings, visitors have crowded the Intarcia exhibit to see how the minipump is inserted and to feel a sample pump below the surface of the model’s artificial “skin.” A separate poster at ADA, in New Orleans, showed that only a tiny portion of the more than 18,000 placements, involving 5200 patients (0.7%), have required a removal.5 During his presentation, Rosenstock said the insertion technique for minipump has improved steadily. “It is very superficial; it does not get too deep.”

  At ADA, Intarcia president and chief executive officer, Kurt Graves, said the results show that ITCA 650 can be an early choice for patients with uncontrolled T2D. “Injectable GLP-1 (glucagon-like
References

  1. 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. Accessed June 12, 2016.

  2. 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.

  3. New NHANES analysis shows no improvement in last decade to get more diabetes patients to HbA1c goal; separate study suggests reduced efficacy in real-world plays large role due to adherence falling far short of clinical trials [press release]. New Orleans, LA: Intarcia Therapeutics; June 12, 2016. http://www.intarcia.com/media/press-releases/2016-june-12-new-nhanes-analysis. html. Accessed July 27, 2016.

  4. Caffrey M. Sanofi’s lixisenatide approved, paving way for OK of combo therapy. The American Journal of Managed Care website. http://www.ajmc.com/newsroom/sanofis-lixisenatide-approvedpaving-way-for-ok-of-combo-therapy. Published and accessed July 28, 2016.

  5. Whitson A. ITCA 650: A novel therapeutic approach to treating type 2 diabetes (T2D). Diabetes. 2016;65(suppl1):1027-P.
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