Intarcia Therapeutics hit a roadblock in September when the FDA pooh-poohed parts of the manufacturing plan for its matchstick-sized, diabetes-treating pump. Now, the company has laid off 60 employees and pulled the plug on two phase 3 trials of the treatment.
The layoffs are part of a restructuring plan, the Boston Business Journal reported. But CEO Kurt Graves said Intarcia is hiring for a number of open positions and does not expect its total workforce to “change significantly in the coming months.”
The Boston-based company seemed to hit its stride in 2016, announcing in June that it was looking to double its employees to about 800 and netting $215 million in the first close of a financing round in September, funds slated for the commercialization of its diabetes drug-device treatment and for the development of other pipeline candidates.
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The Medici drug-delivery system includes an osmotic pump implanted beneath the skin to deliver the temperature-stable exenatide, ITCA 650. Designed to be replaced twice a year, it could potentially improve patient adherence.
Of the two phase 3 studies that Intarcia terminated, the BBJ reported, one was a marketing study pitting the drug-device therapy against approved treatments for Type 2 diabetes, while the other tested it in patients with high levels of baseline HbA1c, which is commonly used to measure blood glucose. Neither study is required for the FDA to approve the treatment.
The FDA placed a hold on the studies after Intarcia reported one of its third-party labs found an “out-of-specification” result in the routine testing of pumps for long-term stability and sterility, the BBJ said. The company halted the trials because it couldn’t pinpoint the underlying cause of the issue, but it plans to begin similar trials after discussions with the FDA.
The company now hopes to resubmit its application for the diabetes treatment around midyear.