- Acumen Pharmaceuticals ( NASDAQ: ABOS ) said on Monday its monoclonal antibody, ACU193, that targets toxic soluble amyloid beta oligomers to treat early Alzheimer’s disease has been granted fast track designation by the U.S. Food and Drug Administration (FDA).
- ( ABOS ) has risen ~7% before the bell.
- ACU193 is currently being studied in the Phase 1 trial, dubbed INTERCEPT-AD.
- ACU193 provides therapeutic benefit with low risk of amyloid-related imaging abnormalities ( ARIA ), because ACU193 blocks the toxic effects of amyloid beta oligomers without directly targeting amyloid plaques.
- The FDA Fast Track program is designed to facilitate the development and expedite the review of new drugs intended to treat serious or life-threatening conditions with the potential to fill an unmet medical need
For further details see:
Acumen rises ~7% on fast track designation for Alzheimer's disease treatment