A diabetes drug delivered continuously from a small implantable pump resulted in a marked and sustained reduction in blood sugar in patients in two studies, potentially setting the stage for a once-a-year treatment option[!] to manage the disease.
The matchstick-size pump…is being developed by closely held Intarcia Therapeutics Inc., a Boston-based startup, which is releasing details of the studies Wednesday. The device holds up to a year's supply of exenatide, a drug already on the market for Type 2 diabetes. It is implanted under the skin in the abdomen where it continuously releases the drug in micro quantities into the body to control blood sugar.
…Intarcia said that in one of the two studies, involving 460 patients, the device when used with standard oral diabetes medicines resulted in average HbA1c reductions of 1.4 to 1.7 percentage points, from an average of 8.5%.
In the other study, which tested 60 high-risk patients with average starting HbA1c levels of 10.8%, the average reduction was 3.4 percentage points to 7.4%—while 25% of patients reached the goal of below 7% after nine months with the pump.
…The exenatide-filled pump was also associated with weight loss, the company said.
…The two studies are among four Phase 3 or late-stage studies Intarcia is conducting with a plan of filing for approval for six-month and 12-month pumps with the U.S. Food and Drug Administration by early 2016. The company also is mounting head-to-head studies against both oral and injectable treatments with the aim of proving the pump superior to the conventional treatments.
Will Intarcia IPO, or will it be bought out while private?