In terms of controlling Type 2 diabetes and potentially obesity, Boston’s Intarcia Therapeutics just released some impressive Phase 3 findings: Its implantable device has been found to be more effective than Januvia, one of the top-selling diabetes drugs on the market.
ITCA 650, Intarcia’s drug under development, works in a similar way as AstraZeneca’s Bydureon – except that rather than coming in injection-form, it’s released very slowly over time. The Intarcia device is, after all, only implanted once or twice a year.
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This is a big deal in terms of potential improvements to medication adherence: Patients can’t forget to take a medication if it’s implanted inside them. And it’s a bold move to go up against Januvia, given its broadscale brand recognition.
Januvia was the first to market and is the top selling drug in its class of drugs, called DPP-4 inhibitors. But they’re not as broadly as effective as the class of drugs that Bydureon and ITCA 650 falls in, called GLP-1 receptor agonists. However, DPP-4 inhibitors can be taken in pill-form, whereas to date GLP-1 receptor agonists have only been available as injections.
ITCA 650 is fed into the body through a small, matchstick-sized subdermal osmotic mini-pump. If approved, ITCA 650 will be the only GLP-1 receptor agonist that’ll work without the need of lifelong daily injections.
In the yearlong Phase 3 trial, called FREEDOM, all patients were dosed with a metformin monotherapy – so the administration of ITCA 650 or Januvia was a secondary means to control the patients’ Type 2 diabetes. It found that more patients on ITCA 650 60 mcg versus Januvia 100 mg had greater reductions in blood sugar as well as weight.
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“These clinical results and the innovative method of administration represent a potential major advance for the entire type 2 diabetes community,” said Dr. Robert R. Henry, a University of California, San Diego professor and trial investigator in the FREEDOM Phase 3 clinical trial program.
“Given the epidemic nature of type 2 diabetes and the immense unmet need within this growing population, I’m extremely encouraged by these results for ITCA 650, and I’m hopeful that this much needed and long-awaited treatment option may be available in the near future.”
Diabetes drug costs are rising at a staggering rate – with Januvia alone up 93 percent in the past five years. So it’ll be interesting to see where an implant like ITCA 650 would fall in the payor system.
The privately held Intarcia is a stunningly well-funded company. It closed out a $225 million “synthetic royalty financing,” which was based on a $5.5 billion valuation. It’s raised about a half billion in equity to date – so, given the positive topline results of ITCA 650, it looks like the investor community will be rather delighted.
