On 15 February, Cortexyme, a clinical-stage pharmaceutical company developing novel treatments for altering the course of Alzheimer’s disease (AD) and other neurodegenerative disorders, announced that a partial clinical hold has been placed on its drug candidate COR388 by the US Food and Drug Administration (FDA).
The fully enrolled GAIN Phase II/III trial will continue as planned, participants with mild to moderate AD will continue to receive the study drug at their assigned dose, with top-line results expected in in the fourth quarter of 2021. The GAIN trial protocol also includes an open-label extension study in the US. Following the institution of a partial clinical hold, the company has stopped enrolment and dosing in this open-label extension.
