Intarcia Therapeutics yesterday unveiled top-line results from a year-long trial of an implantable drug pump for Type II diabetics, saying its ITCA 650 treatment proved superior to its comparator, Merck‘s (NYSE:MRK) Januvia.
Fifty-two week results from the Phase III Freedom-2 trial met all primary and secondary endpoints, “demonstrating superiority over Januvia at every measured time point,” Intarcia said. The matchstick-sized, miniature osmotic pump reduced glycated hemoglobin (HbA1c) levels and weight in patients in the study, the company said. The subcutaneous ITCA 650 is designed to deliver the drug exenatide for 1 year.
Full results from the study are due to be presented for publication and at upcoming medical meetings, the Boston-based company said. Chairman, president & CEO Kurt Graves said the company hopes to apply for regulatory approvals during the 1st half of next year.
“The prospect of bringing a totally new therapeutic approach to the market that has shown a potential to reduce both HbA1c, by a mean 1.5%, and reduce weight, by a mean 4 kg, in the population studied is remarkable,” Graves said in prepared remarks.
Freedom-2 showed that “significantly” more patients in the ITCA 650 arm met the secondary endpoint of glucose reductions greater that 0.5% and weight loss of 2kg or more. More of the cohort treated with the Intarcia device met the American Diabetes Assn.’s recommended HbA1c target o less than 7.0%, the company said.
“These clinical results and the innovative method of administration represent a potential major advance for the entire type 2 diabetes community,” trial investigator Dr. Robert Henry of the University of California-San Diego added. “The comparative data leave little room for speculation about ITCA 650’s potential value in a chronic disease where more than half of all patients are not at the recommended glycemic goal and not adherent to therapy over time.
“If approved, ITCA 650 would be the first and only GLP-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. 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,” Henry said.
Intarcia said Freedom-2 also showed an overall and G.I. tolerability profile similar to the Freedom-1 placebo-controlled trial.
“Discontinuations for nausea were in the low single digits over the full 12 months of treatment,” the company said. “There were no cases of major hypoglycemia in either study arm and minor events of hypoglycemia were reported in the low single digits for both study arms. The placements and removals of ITCA 650 were very well tolerated and the rate of minor infections at the application site was less than 1% of all procedures in the trial.”
Intarcia in April took its total raise to more than $1 billion with a $225 million funding round. Intarcia, which last year inked a $1 billion development deal with French pharmaceutical independent Servier, raised a $210 million round back in November 2012. Last year saw another $200 million addition, plus a $171 million up-front payment from Servier on top of “several” previous bridge rounds of undisclosed amounts.