Intarcia Therapeutics Inc., which is developing a once-yearly implant to treat diabetes, is in advanced licensing talks on its drug-formulation technology for other diseases, Chief Executive Officer Kurt Graves said.
Intarcia is meeting with as many as five pharmaceutical and biotech companies this week to collaborate on its long-acting liquid suspensions for treating conditions including pain and neurological disorders, obesity and cardiovascular disease, Graves said in a phone interview.
The U.S. company secured $210 million in additional financing in November for late-stage clinical trials of its ITCA 650 matchstick-size implantable pump starting this quarter with 4,000 participants. The technology permits continuous delivery of the GLP-1 drug exenatide for as long as a year to treat Type 2 diabetes without injections. The formulation maintains the drug’s stability at human body temperature for as long as three years, and can be applied to other medicines, Graves said.
“It’s a platform that’s pretty exciting” for drugmakers as it eliminates the need for frequent injections, Graves said in the Jan. 4 interview from Boston. Some agreements may be reached in the first half of this year, he said, declining to identify companies that may be interested in working with Hayward, California-based Intarcia.
In mid-stage studies, ITCA 650 was shown to reduce HbA1c, a measure of blood-sugar concentration, by as much as 1.5 percent over 48 weeks, depending on the dose, more than existing treatments including Merck & Co.’s Januvia, Graves said. Exenatide is the chemical name of Bristol-Myers Squibb Co.’s Byetta and Bydureon drugs.
The continuous delivery of the drug, likened to a “glacier moving at a predetermined rate” through the pump, eliminates spikes in the system that accompany daily or weekly injections and typically cause nausea, the CEO said. As a result, no patients stopped treatment over 48 weeks, suggesting outcomes can be sustained over time, he said.
“The notion of an implantable pump is a very interesting notion,” said Moncef Slaoui, chairman of research and development at London-based GlaxoSmithKline Plc, which considered collaborating with Intarcia before deciding to focus on its own GLP-1 drug, albiglutide.
“We looked at it very carefully,” Slaoui said. “If we didn’t have albiglutide in our pipeline, we may have looked at it somewhat differently.”
The challenge for Intarcia will be to ensure no complications arise over the course of a year, especially in terms of the body reacting to a foreign device, Glaxo’s Slaoui said.
Intarcia’s larger phase 3 studies include a head-to-head trial comparing ITCA 650 with Januvia and another that compares it with a placebo.
The U.S. company plans to commercialize the product on its own for the domestic market, seek a large drugmaker as a partner for sales outside the U.S. and eventually take Intarcia public, unless it’s acquired, Graves said.
“What we’re really focused on is maximizing the value of our lead asset,” he said. “The platform has such broad applicability, and additional collaborations can help us finance ITCA 650 and other things, too, depending on how we structure those.”