Cortexyme Inc. (CRTX), in an update on development program for Atuzaginstat in Alzheimer's Disease, said that the U.S. Food and Drug Administration has placed a partial clinical hold on atuzaginstat (COR388) that will impact the open-label extension or OLE phase of the company's ongoing Phase 2/3 study, the GAIN Trial.

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Cortexyme Inc. (CRTX), in an update on development program for Atuzaginstat in Alzheimer's Disease, said that the U.S. Food and Drug Administration has placed a partial clinical hold on atuzaginstat (COR388) that will impact the open-label extension or OLE phase of the company's ongoing Phase 2/3 study, the GAIN Trial.

RTTNews | Feb 15, 2021 10:41PM EST

22:40 Monday, February 15, 2021 (RTTNews.com) - Cortexyme Inc. (CRTX), in an update on development program for Atuzaginstat in Alzheimer's Disease, said that the U.S. Food and Drug Administration has placed a partial clinical hold on atuzaginstat (COR388) that will impact the open-label extension or OLE phase of the company's ongoing Phase 2/3 study, the GAIN Trial.

Therefore, the company said it will not enroll any new participants in the OLE and will discontinue currently enrolled OLE participants.

Participants in the fully enrolled (N=643) double-blind, placebo-controlled randomized phase of the GAIN Trial will continue to receive study drug at their assigned dose, with top-line results from the double-blind GAIN Trial in the fourth-quarter 2021.

Read the original article on RTTNews ( https://www.rttnews.com/3169755/cortexyme-says-fda-places-partial-clinical-hold-on-atuzaginstat.aspx)

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