Intarcia Forming Collaborations While FDA Reviews ITCA 650

Intarcia Therapeutics, which entered a new chapter in November when it filed its new drug application (NDA) for a novel diabetes treatment, has continued to pursue collaborations around its innovative mini-pump technology.

This month, Intarcia announced a licensing deal with Calibr to deliver a “next-generation” combination product to treat diabetes and obesity. This came on the heels of an announcement on December 29, 2016, that the company had raised an additional $206 million in financing that included a relationship with the Bill & Melinda Gates Foundation to use its technology to create a new therapy to prevent HIV.

Filing the NDA for ITCA 650, which delivers a continuous, microscopic dose of exenatide for patients with type 2 diabetes (T2D), marked a milestone in more ways than one. Not only did Intarcia present the fruits of its 10-year effort to change the treatment paradigm in chronic disease, but the filing also triggered a $100-million milestone payment, based on 2015 financing.

Intarcia’s matchstick-size mini-pump, which delivers a continuous, microscopic dose of exenatide, has drawn attention at successive meetings of the American Diabetes Association (ADA), both for the glycated hemoglobin (A1C) reductions seen in trials and for a delivery system that observers have called a “game changer.” The prospect of overcoming poor medication adherence rates in T2D with a subcutaneous pump that can be replaced just once or twice a year has drawn large crowds to sessions and to Intarcia’s demonstration booth the past 2 years at ADA.

Results from trials have shown that ITCA 650 produces larger A1C improvements than sitagliptin—a top-selling T2D therapy—and Intarcia announced in May 2016 it had achieved the cardiovascular safety outcomes needed for FDA approval. Full results of that trial, FREEDOM-CVO, have not yet been presented. That same month, Intarcia also announced the branding of its drug delivery system, Medici, which includes the subcutaneous mini-pump, the placement technology, and the technology to keep therapies stable at or above human body temperatures.

The collaboration with California Institute for Biomedical Research (Calibr) surrounds Calibr’s stapled-peptide platform technology. It calls for Intarcia to develop this therapy in combination with exenatide—the active agent in the ITCA 650—through use of the Medici system. “We are committed to disruptive innovation leveraging our proprietary Medici Drug Delivery System, and we now have several combination products in our pipeline that we believe can uniquely optimize delivery in a once- or twice-yearly mini-pump,” said Intarcia CEO Kurt Graves in a statement.

The collaboration with the Gates Foundation calls for Intarcia to develop a once- or twice-a-year therapy that would stop the spread of HIV, which the foundation’s CEO, Sue Desmond-Hellman, described as a “vital need.”

"We feel optimistic about our partnership with Intarcia and the prospect of an implantable prophylactic device that could make a world of difference for people most in need,” Demond-Hellman said.