Unambiguous differentiation in FREEDOM-2! A clear statement that captures the essence of our third Phase 3 clinical trial for ITCA 650, our late-stage investigational therapy for type 2 diabetes! Our data adds more promise, hope and excitement for the many patients who are not reaching or maintaining proper blood glucose levels. Our new data speaks for itself and ITCA 650 is establishing an impressive, consistent and very promising clinical profile to date.
The new results from the FREEDOM-2 Phase 3 trial (see press release by clicking here) demonstrate ITCA 650 delivered superior clinical results on all primary and secondary endpoints in the study related to glucose reductions, weight reductions, the percent of patients treated to A1c goal, and the composite endpoint which combined glucose and weight reductions. These multi-dimensional advantages demonstrated in the trial are noteworthy considering the very large number of type 2 diabetes patients not treated to goal and not kept at goal over time. They are also noteworthy given the fact that Januvia® (sitagliptin) is the current market leading oral therapy globally, having posted over $6 billion in 2014.
What’s most exciting for all of us at Intarcia is this: If there is a “winning ticket” associated with FREEDOM-2, someday soon we want it to be held by the large number of people with type 2 diabetes who are in need of and urgently waiting for a better solution to help them achieve and maintain the glycemic control and body weight reductions that could potentially improve their short and long-term health. We believe business success follows patient success. These results are so clear and so strong that they give us hope that patients, providers, and payers may well share that “winning ticket” soon. And that is the best kind of disruptively innovative clinical progress: The kind that may provide appropriate patients very meaningful benefits that permeate the entire healthcare system so that everybody we care about wins.
Our vision and business model is to deliver innovation so significant that it has the potential to create a whole new approach to delivering chronic medicines, and results that show disruptive advantages versus the current standards of care. Accordingly, this has always been our goal for ITCA 650 in type 2 diabetes. Thanks to FREEDOM-1 and FREEDOM-1 HBL, we demonstrated the promise and potential of a totally new therapeutic approach. And now, FREEDOM-2 reveals ITCA 650 was superior on all endpoints evaluated. ITCA 650 reduced HbA1c by an impressive 1.5% compared to Januvia’s 0.8%, and reduced weight by 4.0 kg in the population studied versus Januvia with only a 1.3 kg reduction. ITCA 650 was also superior on the secondary endpoint assessing the number of patients treated to the ADA’s HbA1c goal of <7% as well. Additionally, on top of these remarkable clinical results, we’re introducing something that won’t add the burden of daily pills or frequent life-long self-injections. Our potential once or twice-yearly dosing has some built-in compliance and adherence aspects that are very important in a chronic disease where many patients struggle to adhere to their therapies after just 3-6 months.
Adverse events in FREEDOM-2 demonstrated an overall and G.I. tolerability profile very 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. This profile for a totally new approach to delivering medicine is a testament to our world class training efforts, our global clinical trial educators, our development team and partner, and the quality of our investigators and their staff.
Taken together, when you add up our first three Phase 3 trials it definitely feels like we’re looking at something as disruptively innovative as we always hoped and dreamed. And it couldn’t come at a more important time in our global fight against type 2 diabetes.
Many people thought we’d never make it this far, never be able to raise enough money to stay independent, or never be able to produce results nearly this robust and unambiguous. But we’ve never had one doubt since we put our vision in place 5 years ago, and these results will only inspire us to keep moving faster and even more tenaciously as we go.
Speaking of being financed, the other good news with the FREEDOM-2 clinical trial is that it also triggers another $100 million milestone payment to us per the terms of our recent $300 million royalty/equity convert financing. We remain very well financed and now 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 2016, and then to make ITCA 650 available to appropriate patients and the broader healthcare system.
We have much to do in the remainder of 2015 as we continue to scale and build our business, our team, our pipeline, our capabilities and our key partnerships.
I want to thank everyone involved in our endeavors for their commitment to excellence and tenacious support. A special note of thanks to everyone involved in our Phase 3 trials on a daily basis in clinical, manufacturing, regulatory, customer experience & outcomes, and to our global development partner − Quintiles. It is a continuously rewarding experience to be able to lead an organization as committed to winning on behalf of patients as ours, with disruptively innovative new ways to approach long-standing clinical problems and to address unmet needs that are impacting millions of lives. We see so much future potential and opportunity, yet fully acknowledge the huge challenges and unmet needs that drive us everyday. With the new data in our hand we now realize more than ever that we have a huge responsibility to patients around the world. I thank all our people and all our stakeholders for their steadfast support and unwavering commitment.
Chairman, President and CEO
Intarcia Therapeutics, Inc.