[This report has been updated from an earlier version to include a statement issued by Intarcia].

Intarcia Therapeutics has eliminated approximately 60 of its 300 positions–about 20% of its workforce—and terminated two Phase III trials assessing a diabetes drug/device combination following an FDA clinical hold.

Intarcia CEO Kurt Graves disclosed the job cuts to the Boston Business Journal, saying that most of the eliminated positions were based at its Hayward, CA, manufacturing site, though 11 of the idled employees were based at Intarcia’s Boston headquarters.

Graves added that the company was also looking to hire enough new staffers to keep its workforce at the same approximately 300 people it had before the layoffs–something the company repeated in a subsequent statement issued to GEN and other news outlets.

“The net/net headcount changes are expected to be relatively neutral over the course of the year,” Intarcia said in its statement. “The restructuring and reshaping involves roughly 60 positions that were reduced across various functions, however, it also involves ongoing hiring in key areas of the company that support our 2018 priorities.”

The job cuts came more than four months after the FDA refused to approve Intarcia’s ITCA 650, (exenatide implant), a drug/device combination indicated for type 2 diabetes.

In September 2017, Intarcia disclosed that the FDA issued a Complete Response Letter (CRL) to the company’s New Drug Application (NDA) for ITCA 650, but did not detail why, except to say: “The Company received clear and constructive guidance from the Agency regarding manufacturing aspects of the CRL and is on a clear path to move forward.”

ITCA 650 is designed to provide continuous delivery of exenatide via a matchstick-sized osmotic minipump placed just beneath a patient’s skin in the abdominal wall—what Intarcia calls its Medici Drug Delivery System.

“Out-of-Specification” Result

Graves told the newspaper that the FDA clinical hold was imposed after Intarcia reported to the agency that one of its third-party laboratories found an “out-of-specification” result while testing some of the pumps for long-term stability and sterility.

Intarcia says the outlying result and resulting clinical hold did not affect studies used in its NDA for ITCA 650—but affected two ongoing marketing studies whose terminations Intarcia disclosed January 30 on ClinicalTrials.gov:

  • A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes in Patients with High Baseline HbA1c (NCT01785771)
  • Comparison of Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and Glimepiride as add-on Metformin (NCT03060980)

The two trials were ended after Intarcia could not identify the cause of the outlying result seen in pump testing. Intarcia plans to relaunch similar trials pending discussions with the FDA. Following those talks, Intarcia plans to resubmit its NDA for ITCA 650.

“As Intarcia Therapeutics, Inc. works towards resubmission and the ultimate goal of approval for ITCA 650, a holistic assessment of the organization was conducted, and the decision was made to restructure and reshape the company to focus on our critical priorities,” Intarcia said in its statement.

Intarcia has previously cited other clinical studies showing that ITCA 650 minipumps were given with a 20 μg/day three-month introductory dose and then followed by a 60 μg/day six-month maintenance dose—translating to twice-yearly dosing after initiation.

In announcing the CRL, Intarcia insisted that it remained in a strong fiscal position, having raised more than $600 million through September 2017 in a Series EE equity financing, and having anticipated “multiple” near-term milestone payments from its ex-U.S. collaboration. Intarcia has granted Servier exclusive rights to develop ITCA 650 outside the U.S. and Japan, through a $1 billion-plus collaboration launched in 2014.

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