August 19, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Boston-based Intarcia Therapeutics, Inc., announced yesterday positive results from its Phase III Freedom-2 clinical trial comparing its late-stage ITCA 650 to Merck & Co. ’s Januvia for Type 2 diabetes.
The real news here is that ITCA 650 is a new type of diabetes treatment. It is a GLP-1 receptor agonist that utilizes a small subdermal osmotic mini-pump that is placed under the skin and continuously delivers exenatide with dosing only once or twice a year. In other words, instead of regular injections or pills, the mini-pump is put in the patient every six to 12 months. The pump is described as being about the size of a match.
“If approved, ITCA 650 would be the first and only GLIP-1 receptor agonist to offer a viable alternative to regular life-long injections, and, with once or twice yearly dosing, it has the potential to enhance patient compliance, which has also been a long-standing, unresolved problem and a major contributing cause of poor glycemic control over time,” said Robert Henry, chief, VA Endocrinology & Metabolism, and professor of medicine in residence at University of California, San Diego (UCSD), an investigator in the trial, in a statement. “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.”
ITCA 650 reduced blood glucose by 1.5 percent, compared with 0.8 percent for Januvia. The study lasted a year and looked at 535 patients. It also resulted in an average weight loss of about 9 pounds compared to about 3 pounds for patients taking Januvia.
Intarcia is a closely held company backed by venture-capital firms. Investors include New Enterprise Associates Inc. and Venrock. It has partnered with another private company in France, Les Laboratoires Servier SAS, to develop and market ITCA 650 outside the U.S. and Japan.
The positive clinical trial data triggered a $100 million payment to investors.
Intarcia was founded in 1997 and has generated $759.3 million in 10 funding rounds, according to Crunchbase. The most recent private equity round was April 27, 2015 and raised $225 million. Previous investors have included RA Capital Management, Farallon Capital Management, Foresite Capital, Fred Alger Management, New Leaf Venture Partners, Quadrile Partner, GGV Capital, Venrock, and New Enterprise Associates.
In May 2015, the company won the Deal of the Year in Healthcare at the Third Annual NEVY Awards. It was also named to the “CNBC Disruptor 50” List, only one of two biopharma companies named. This list notes innovations that “are revolutionizing the business landscape.”
Merck, whose Januvia brought in $6 billion in worldwide sales last year, responded, saying, “We are confident that physicians will continue to choose Januvia, the world’s leading branded oral diabetes medicine, to help a broad range of patients with Type 2 diabetes.”
Perhaps, but if approved, ITCA 650 could solve many problems for diabetic patients and physicians in terms of compliance. “It’s unbelievable how hard it is to make people stay on a chronic medication,” said Anne Peters to The Wall Street Journal. Peters is a professor of medicine at the Keck School of Medicine at the University of South California. “Especially when they don’t feel sick. If this helps adherence, and over the long haul I think it will, it’s going to make a big difference.”
Intarcia plans to file for regulatory approval in the first half of 2016.
