FREEDOM-CVO, the last and the largest of the Phase 3 trials, showed ITCA 650 met its primary and secondary endpoints, satisfying CV safety requirements for regulatory filing.
We have great news to share! With the successful completion of our FREEDOM-CVO Safety Phase 3 study that included more than 4,000 patients, our entire Pivotal Phase 3 Trial Program is finished. We now turn our full attention to compiling all our development and manufacturing information so we can file with regulatory authorities. Our stretch goal is to file in the U.S. by the end of 3Q 2016. We have rounded the corner from very large and global clinical trials to the “homestretch” of filing and the near-term prospect of commercialization. In this regard we look forward to working closely and cooperatively with regulatory authorities.
Ours is an industry that too often must experience legitimate failures and disappointments in the pursuit of meaningful innovation and clinical progress. And when success does occur, it very often is incremental in nature. With ITCA 650, we have had the privilege of consistently impressive clinical findings that indicate an underlying fundamental difference that shows its promise as a disruptive innovation from current standards of care. The prospect of making a real stride forward in type 2 diabetes thoroughly excites and encourages all of us at Intarcia, and fires-up our passion to overcome the considerable challenges that still lie ahead so that we will prevail on behalf of patients, providers and payers.
In terms of the most recent mountain we climbed – the FREEDOM-CVO Safety Study – I offer my thanks to the thousands of patients, our investigators, and all of our people and our partners who delivered on this amazing challenge and opportunity! Most everything looks easy once it has been seemingly effortlessly achieved. This was a ton of effort and tenacity of purpose from everyone involved!!
Not unrelated to our new CVO safety success – and having all the data we need to complete our filings – Intarcia also has completed a $75 million round of financing to support our manufacturing scale-up and inventory build for our global launches. I give our sincere thanks to Silicon Valley Bank and MidCap Financial as our investors in this most recent round.
Taking a moment to reflect about our good news, something came to mind: All things considered, at this moment we are truly right where we had hoped to be when we started this Phase 3 program several years ago. And back then many outsiders thought the whole idea was just a twinkle in our eyes. That twinkle feels very tangible now. So again, I extend my thanks to the ‘village of people’ that came together to make it happen thus far.
But we are far from done, and we acknowledge the tremendous tasks ahead. As daunting as our prospective challenges are, they are even more exciting and important to overcome, because on the other side is the amazing rush we all crave – meaningful innovation that makes a real difference in people’s lives.
Intarcia hopes to earn a reputation as a fearlessly dedicated team of talent capable of building a track record of success where it is sorely needed, and where others have tried and failed. We hope to deserve your increasing interest, trust and respect as our work progresses. Stay tuned!
Chairman, President and CEO
Intarcia Therapeutics, Inc.