Pfizer, Verily-backed Alzheimer's biotech Cortexyme hit by FDA partial hold over liver toxicity

Pfizer, Verily-backed Alzheimer's biotech Cortexyme hit by FDA partial hold over liver toxicity

Source: 
Fierce Biotech
snippet: 

As it looks for a new way to treat Alzheimer’s and clear a near 20-year backlog of failed R&D for the memory-wasting disease, big-name-backed biotech Cortexyme has hit a snag.

The FDA has slapped a partial clinical hold on its leading Alzheimer’s drug atuzaginstat (aka COR388), hitting specifically the open-label extension part of its ongoing phase 2/3 study, known as the GAIN Trial.

Under the hold, the California company, backed by the likes of Pfizer, Verily and Takeda, won’t be able to enroll new patients in the open-label extension segment of the test, and currently enrolled participants “will be discontinued,” the biotech said in a statement.