Diabetes: Intarcia’s implantable drug pump tops Merck’s Januvia

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 ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Diabetes Drug Pumps Intarcia Therapeutics newtag Source Type: news