Here are eight things to know.
1. Eleven of the layoffs affected employees at the Boston headquarters, while the other layoffs occurred at Interacia’s manufacturing plant in Hayward, Calif. Intarcia CEO Kurt Graves told the Boston Business Journal the layoffs were part of a restructuring plan and were not a result of the trial setbacks.
2. Mr. Graves does not expect the company’s headcount, which was around 300 total employees prior to the layoffs, to significantly change in the upcoming months.
3. The company’s lead diabetes treatment, ITCA 650, is a small device that is surgically inserted into the abdomen and gradually pumps tiny amounts of the drug exenatide into the blood stream.
4. The trial setbacks for the ITCA 650 began in late September when the FDA declined to approve the drug-device. Despite the setback, the company will still fight for approval.
5. However, the company hit another snag. Intarcia recently announced it terminated two Phase 3 studies of ITCA 650. One study, a marketing study, compared the device to other approved treatments of Type 2 diabetes. The other study tested ITCA 650 in patients with high levels of hemoglobin. While neither study is necessary for FDA approval, Mr. Graves said Intarcia needed to halt the studies to investigate an “out-of-specification” result.
6. According to Mr. Graves, one of Intarcia’s third-party labs found issues regarding the long-term sterility and stability of the device. The FDA placed a hold on the studies while they investigated the issue. Because the drugmaker was unable to identify the root cause of the issue and was unable to address the FDA’s concerns over the device, the trials were terminated.
7. According to Mr. Graves, patients would have continued to drop out of the studies after the issues were brought up, which would have rendered the data useless.
8. Pending discussions with the FDA, the company plans to relaunch similar trials and is still seeking approval for the device.
Editor’s note: This article was updated Feb. 12 at 8:42 a.m. to clarify the ITCA 650 device pumps out the drug exenatide, not insulin.
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