We are incredibly pleased and proud that two of our Phase 3 trials in type 2 diabetes demonstrated very positive results for our lead product candidate − ITCA 650. These two trials show that ITCA 650 has the potential to play a game-changing role in shaping the future treatment options for this devastating disease. Our results are unambiguous and we are two major steps closer to introducing the first and only once- or twice-yearly therapy for type two diabetes. This is a rare opportunity to make a huge difference for such a large and underserved patient population that is growing in epidemic proportion every year. The positive results of these two trials validate the breakthrough technology and chemistry behind our drug delivery platforms. But more importantly, they give reason for hope to many type 2 diabetes patients who struggle to get control of their blood sugars and weight and stay adherent and controlled over time. At Intarcia, making a big difference in the lives of these patients is what brings us to work everyday with a strong sense of purpose and urgency.
The FREEDOM-1 trial was a pivotal, placebo-controlled, phase 3 trial examining the safety, efficacy and tolerability of ITCA 650 in type 2 diabetes patients. This trial met its primary endpoint by demonstrating the superiority of 60 mcg/day or 40 mcg/day ITCA 650 in reducing HbA1c following 39 weeks of treatment. We also met our secondary endpoints as measured by reduction in body weight over 39 weeks, and the proportion of patients brought to goal with HbA1c levels <7%. This is incredibly good news.
Highlights from the FREEDOM-HBL trial were quite frankly stunning. This open-label trial enrolled patients with baseline blood sugar exceeding the entry criteria to enroll in FREEDOM-1 – these patients had baseline HbA1c levels so high it was considered medically unethical to include them in placebo controlled trials because supplemental active therapy was clinically warranted to address their serious condition. Many of these patients had type 2 diabetes for 9 years and struggled, many times while on multiple medications, to control their dangerously high glucose levels. When we added ITCA 650 to their regimen, 25% of these patients were brought from their baseline levels of 10-12% to the ADA HbA1c goal of <7% at week 39 of the trial. Overall, this trial showed a remarkable and statistically significant mean reduction in HbA1c at 39 weeks of 3.4% vs. the mean starting baseline of 10.8%. To everyone at Intarcia, that is truly stunning and deeply gratifying, and a cause for us to celebrate for what this may mean for patients ahead. There is a vast amount of interesting data from both of these studies, and we will be submitting the full data from these trials to the 75th Scientific Sessions of the American Diabetes Association, which take place in Boston in June of 2015, right across the street from our new Headquarters.
This achievement is the culmination of nearly 15 years or more of hard work and dedication by our employees, investors and partners to advance this potentially transformational therapy toward the finish line. Quintiles, Inc., our strategic development partner on our FREEDOM clinical trial program, has done a great job in helping us complete the first two of the four phase 3 trials that will support our regulatory filings. Our FREEDOM-2 and FREEDOM-CVO studies continue to progress on schedule; we expect full data from FREEDOM-2 by the end of summer 2015, and partial but important cardiovascular safety data from FREEDOM-CVO in the second half of 2015. If all continues to go as planned, we anticipate submitting our first filing for regulatory approval of ITCA 650 here in the U.S. by early 2016.
Through all of our milestones of progress, our landmark private financings have allowed us to remain independent and in control of our vision. I believe this independence has been critical to our ability to move decisively and deliver on our full vision for ITCA 650 and the value of its clinical potential to patients, providers and payors who are eagerly awaiting new solutions for the management of type 2 diabetes.
Put simply, our vision is to build a disruptively innovative biotechnology company that makes significant differences and breakthrough medicines for patients around the world. Nothing about that vision has changed since I joined Intarcia. We remain on course and there is still much to be done, but with ITCA 650 we now have strong evidence in our hands that shows we are well on our way.
Every company has its unique characteristics. We have people who are tenacious about being disruptively innovative, about winning for patients, and about achieving our mission and goals. We have a will to win and we don’t mind when people tell us it’s never been done before or that something can’t be achieved because there is no analogue. Instead, that is when we rise up and say, “Watch us!” Yet at the same time, alongside that tenacity and that will to win, they are very patient-focused and deeply caring about what they do and why they do it.
I’m proud and fortunate to lead such a great team of talent. My job is to keep us focused on our vision, our goals, patients, and our fundamental accountability for performance and a culture that is consistent with our core values. As we build and accelerate our growth, it is also about attracting, developing and unleashing the full potential of our talent so they can continue to go about being disruptive and making the huge differences for patients they are clearly capable of achieving. Last but certainly not least, I’m equally proud of our investors for their long-sighted wisdom, and our core partners and advisors for their shoulder-to-shoulder support.
To all our stakeholders, I offer my sincere thanks and appreciation.
Keep watching us and supporting! The best and most fulfilling chapters of our story are yet to come. The patients are waiting.
Chairman, President and CEO
Intarcia Therapeutics, Inc.