Intarcia Therapeutics said today that it raised another $75 million in a debt financing round and touted the top-line cardiovascular safety data from the final phase in its clinical program for its ITCA 650 implantable drug pump for Type II diabetics.
Boston-based Intarcia said it plans to begin filing for U.S. approval from the FDA during the 3rd quarter, now that the safety data is in from its 4,000-patient Freedom-CVO trial. The debt financing, a new credit facility with MidCap Financial and Silicon Valley Bank, is slated for scaling up its manufacturing for the ITCA 650, the company said.
The device is a matchstick-sized, miniature osmotic pump designed to deliver the drug exenatide for 1 year.
“The completion of our Freedom-CVO safety trial is the most recent of 4 consecutive and successful clinical milestones for Intarcia, marking the end of our large pivotal Phase III trials required for the regulatory submissions for ITCA 650,” chief medical officer for diabetes Dr. Michelle Baron said in prepared remarks. “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.”
The trial, a global, placebo-controlled cardiovascular outcomes study, compared the safety of ITCA 650 at 60mg daily with a placebo. In the more than 4,000 patients studied, there were a total of 160 strict major adverse cardiac events, Intarcia said.
The company said it’s planning to run more pre- and post-approval studies, including head-to-head trials comparing ITCA 650 with “market-leading oral and injectable medicines.”
“Pre-approval CV safety trials like ours are smaller in size, shorter in duration, and designed very differently from the much larger and longer-duration trials that the FDA requires to assess CV safety or the potential for CV benefit in a post-approval setting,” chairman, president & CEO Kurt Graves said in prepared remarks. “Intarcia will consider the best way to evaluate the potential magnitude of CV benefit possible with ITCA 650 going forward. Our once or twice-yearly dosing and the built-in adherence aspects of our novel therapy could be very important to document in this chronic therapy setting.
“In addition to clinical trial data, payers really want to see high quality ‘real-world’ outcomes data because real-world effectiveness and performance over time is what payers really care about and what they should really want to pay for,” Graves said.
Intarcia in April 2015 took its total raise to more than $1 billion with a $225 million funding round. Intarcia, which in 2014 inked a $1 billion development deal with French pharmaceutical independent Servier, raised a $210 million round back in November 2012. Two years later there was another $200 million addition, plus a $171 million up-front payment from Servier on top of “several” previous bridge rounds of undisclosed amounts.
In September 2015 Intarcia acquired former GlaxoSmithKline enteroendocrine discovery performance unit Phoundry Pharma for an undisclosed amount.