FDA

Slammed by a trial hold, Intarcia terminates studies and axes staff in wake of an FDA rejection

Intarcia’s troubled late-stage efforts to revolutionize the way diabetes is treated has run into a fresh round of setbacks.

The Boston-based biotech — a private company once valued at $3.5 billion — confirmed to Endpoints News late Friday night that the company has cut 60 staffers and been hit by a clinical hold from the FDA.

Kurt Graves

Those setbacks come four months after the FDA rejected Intarcia’s implanted diabetes drug/device, which is designed to deliver stable doses of exenatide with twice-yearly tune-ups. Intarcia CEO Kurt Graves has long championed the device as a certain blockbuster, earning kudos and $600 million in Series EE investment capital along the way.

The Boston Business Journal first reported the layoffs and the clinical hold. A company spokesperson tells Endpoints:

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. 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 net/net headcount changes are expected to be relatively neutral over the course of the year.

Separately, the clinical hold was put in place for ongoing marketing studies and it is not related to the pivotal trials data in our NDA application.  The clinical hold was implemented to allow for an investigation of a 3rd party lab result, not previously observed, during routine long-term monitoring of ITCA 650 product batches.  The investigation was recently completed and we plan to update the FDA to address the clinical hold around the time of our planned resubmission this year.

BioCentury reported Friday night that Intarcia terminated two late-stage studies earlier in the week, noting that the terminations were recorded on clinicaltrials.gov. Both those terminations were recorded as a “decision by sponsor.” The news service reported:

The terminated Phase IIIb trial compared ITCA 650 to empagliflozin or glimepiride as an add-on therapy to metformin in patients with Type II diabetes. The second trial was a Phase III sub-study evaluating ITCA 650 in Type II diabetic patients with high baseline HbA1c.

The company spokesperson had this to add:

For clarity on Biocentury, the clinical hold impacted the two trials noted and did not relate to the pivotal trials in the NDA application.  The trials were being done for commercial purposes and are not required for the NDA review.

Holds and product rejections are not acknowledged or explained by the FDA, which keeps most of its interactions with companies secret.


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