Intarcia Therapeutics announces positive top-line results from ITCA 650 Phase 3 FREEDOM-2 clinical trial

Intarcia Therapeutics, Inc. today announced positive top-line results from its 52-week Phase 3 FREEDOM-2 clinical trial to determine the comparative efficacy of the company's late-stage investigational candidate ITCA 650 to Merck's Januvia in reducing HbA1c in patients with type 2 diabetes following a year of treatment. All patients were on background metformin monotherapy. ITCA 650 is an injection-free GLP-1 receptor agonist in development that continuously delivers exenatide with just once or twice-yearly dosing via a small matchstick-size subdermally placed osmotic mini-pump. In the FREEDOM-2 trial, ITCA 650 met all primary and secondary endpoints, demonstrating superiority over Januvia at every measured time point through and including week 52 endpoints for reduction in HbA1c and reduction in body weight (BW). ITCA 650 is not yet being investigated for the management of obesity. Full details of the trial results will be submitted for publication and presentation at major medical meetings including data on the following:

• Significantly more patients on ITCA 650 60mcg versus Januvia 100mg achieved the secondary composite endpoint combining glucose reductions of > 0.5% and weight reductions of 2 kg or greater; ITCA 650 results were superior vs. Januvia 100mg
• Significantly more patients on ITCA 650 60mcg achieved the ADA-recommended HbA1c target of < 7.0% versus Januvia 100mg; ITCA 650 results were superior vs. Januvia 100mg

"These clinical results and the innovative method of administration represent a potential major advance for the entire type 2 diabetes community," said Robert R. Henry, M.D., Chief, VA Endocrinology & Metabolism, and Professor of Medicine in Residence at UCSD, and an investigator in the FREEDOM Phase 3 clinical trial program. "The comparative data leave little room for speculation about ITCA 650's potential value in a chronic disease where more than half of all patients are not at the recommended glycemic goal and not adherent to therapy over time.

"If approved, ITCA 650 would be the first and only GLP-1 receptor agonist to offer a viable alternative to regular life-long injections, and, with once or twice yearly dosing, it has the potential to enhance patient compliance, which has also been a long-standing, unresolved problem and a major contributing cause of poor glycemic control over time. Given the epidemic nature of type 2 diabetes and the immense unmet need within this growing population, I'm extremely encouraged by these results for ITCA 650, and I'm hopeful that this much needed and long-awaited treatment option may be available in the near future."

In the FREEDOM-2 trial, ITCA 650 60 mcg/d also demonstrated an overall and G.I. tolerability profile similar to prior Phase 3 results recently presented at ADA in the FREEDOM-1 placebo-controlled trial. Discontinuations for nausea were in the low single digits over the full 12 months of treatment. There were no cases of major hypoglycemia in either study arm and minor events of hypoglycemia were reported in the low single digits for both study arms. The placements and removals of ITCA 650 were very well tolerated and the rate of minor infections at the application site was less than 1% of all procedures in the trial.

Kurt Graves, Chairman, President and CEO of Intarcia, commented: "Our third Phase 3 trial results mark another major milestone for our company. The comparative results on all study endpoints for ITCA 650 vs. Januvia were unambiguous and compelling, particularly in light of how widely Januvia was prescribed worldwide last year, with global sales of more than $6 billion. What is even more exciting and important to me are the strength and sustained reductions demonstrated by our data over 52 weeks. The prospect of bringing a totally new therapeutic approach to the market that has shown a potential to reduce both HbA1c, by a mean 1.5%, and reduce weight, by a mean 4 kg, in the population studied is remarkable." Graves continued, "Add to that our planned once or twice-yearly dosing, a very important and new delivery alternative to daily pills and life-long self-injections that many patients have difficulty adhering to after just 3-6 months. ITCA 650 was designed with built-in compliance and adherence aspects that can really matter over time and future real-world comparative outcome studies will look to reinforce how this can potentially transform treatment outcomes in diabetes. To date, injectable type 2 diabetes medicines have really struggled to be used to any significant degree early in the disease after front-line metformin fails. Our FREEDOM-2 data clearly show our potential in this early post-metformin setting and our market research shows our novel dosing opens up a large segment of the market that injectable medications have only marginally penetrated. We look forward to working closely with global health authorities and our partners as we prepare ITCA 650 for regulatory filings in the first half of next year, and then to make it available to appropriate patients and the broader healthcare system."

SOURCE Intarcia Therapeutics, Inc.