Intarcia Announces Successful Cardiovascular Safety Results in Phase 3 FREEDOM-CVO Trial for ITCA 650, an Investigational Therapy for Type 2 Diabetes

BOSTON., Intarcia Therapeutics, Inc. today announced top-line results from its more than 4,000 patient Cardiovascular Safety Study (FREEDOM-CVO trial), clearing the last major clinical hurdle in the global FREEDOM Phase 3 Clinical Trial Program that started in early 2013. Regulatory filing in the U.S. is targeted for end of 3Q, 2016. The Company also announced a $75 million round of debt financing timed to facilitate ongoing scale-up of manufacturing and the production of inventory for the anticipated global launch of ITCA 650 in type 2 diabetes. The new credit facility is with MidCap Financial and Silicon Valley Bank.

"The completion of our FREEDOM-CVO safety trial is the most recent of four consecutive and successful clinical milestones for Intarcia, marking the end of our large pivotal Phase 3 trials required for the regulatory submissions for ITCA 650," said Dr. Michelle Baron, Chief Medical Officer for Diabetes at Intarcia Therapeutics. "The FREEDOM-CVO trial was designed to test CV safety in a pre-approval setting, and we are pleased that it has achieved all of its clinical endpoints and was completed on time. We look forward to working closely with global health authorities as we rapidly prepare for our regulatory submissions and reviews."

Kurt Graves, Chairman, President and CEO of Intarcia Therapeutics added, "The FREEDOM Phase 3 Clinical Trial Program for ITCA 650 has come to a close at an exciting and auspicious time in the GLP-1 receptor agonist category: A time when our global phase 3 program has successfully completed, and a time when new medical evidence from larger and longer-term trials is just emerging showing that GLP-1 receptor agonists may provide potential cardiovascular benefit to patients. 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 ten years ago. That is because we fundamentally designed and investigated ITCA 650 to address future unmet needs and opportunities with type 2 diabetes patients in mind. ITCA 650 represents the first and only once or twice-yearly GLP-1 in development: a totally differentiated approach for chronic medicine delivery that we aim to show can bring important potential benefits to patients, payers and providers who seek earlier and better control of type 2 diabetes, dramatically improved medication adherence and control rates over time, and an important alternative to life-long self-injections of GLP-1s and pills that the vast majority of patients with diabetes struggle to persist with after just six months of initiating therapy."

Source: Intarcia Therapeutics, Inc.