Intarcia Therapeutics, Inc. has just announced the results from two phase three clinical trials for ITCA 650 (exenatide) in Type 2 Diabetes, FREEDOM-1 and FREEDOM-1 High Baseline (HBL). These trials are evaluating patients in which diabetes is not controlled by standard oral anti-diabetes medications, such as metformin and metformin-based combinations. ITCA 650’s active agent, Exenatide, is a glucagon-like peptide-1 (GLP-1) receptor agonist.
Both clinical trials, FREEDOM-1 and FREEDOM-1 HBL were placebo-controlled, double-blind studies with type 2 diabetes patients whose HbA1c values were not controlled by diet and exercise alone. However, FREEDOM-1 HBL subjects had baseline HbA1c values between 10% and 12%, and were therefore termed HBL. The trials aimed to evaluate safety and efficacy of ITCA 650 as a continuous subcutaneous delivery of exenatide for types 2 diabetes.
In both trials, ITCA 650 significantly improved hyperglycemia levels in type 2 diabetic patients when added to standard oral diabetes medications over the period of 39 weeks. In FREEDOM-1, patients with a starting HbA1c baseline of 8.5% or higher had a significant reduction achieving mean reductions up to 2.1%. In FREEDOM-1 HBL the HbA1c levels had a sustained reduction from a starting baseline of a mean 10.8% to 3.4% at the end of the trial. In both studies, ITCA 650 was well tolerated by patients gastrointestinal tract with the low single digits for nausea.
These results and further details will be presented in Boston, June 2015 at the American Diabetes Association (ADA) annual meeting.
Robert Henry, M.D., Chief, VA Endocrinology & Metabolism, and Professor of Medicine in Residence at UCSD commented, “I am extremely pleased with these phase 3 results. They delivered everything one could have hoped regarding ITCA 650’s ability to provide sustained blood sugar control for many type 2 diabetes patients who are not achieving their goals — and all of this without the need for regular self-injections. I think these new data indicate clearly that the ITCA 650 method of delivery provides an uninterrupted, smooth and continuous dose that assures adherence without the need for patient action or behavior modification, which we all know is extremely challenging for many patients. With continued success in the remaining phase 3 trials, we should have a real game-changing therapy available soon to help physicians to better manage this serious disease. We desperately need new innovations like ITCA 650 that have the potential to positively affect the treatment of this devastating and growing epidemic worldwide.”
Kurt Graves, Chairman, President and Chief Executive Officer of Intarcia noted, “Our first phase 3 results are truly remarkable and they mark a major milestone for our company and for our mission to bring potential game-changing and life-enhancing therapies to patients, payors, and providers. We will continue our aim to be disruptively innovative in diabetes and metabolism while also building a focused pipeline in other chronic and serious diseases where we believe we can win for patients. We now have evidence that we have a totally new and transformational way of delivering important medicines. Many thought an emerging biotech company could never innovate enough, finance enough, or execute well enough to bring a transformational therapy through phase 3 in a major disease area like type 2 diabetes. But we’ve proven it can be done, and done well. This landmark event for Intarcia was made possible by our vision and our pioneering people, our world-class investors, our key partners like Quintiles, and the 5,000 people who are volunteering for our clinical studies, and the doctors, nurses/PAs and clinical trial coordinators who’ve managed those studies. I offer my heartfelt thanks to each and every one of them. We now look forward to finishing the rest of our trials and working closely with global health authorities as we strive to prepare ITCA 650 for filing and registration, and then to make it available to patients and the broader healthcare system.”