Anavex clarifies AVATAR Phase 3 trial endpoints; plans FDA meeting for Rett syndrome approval

ANAVEX LIFE SCIENCES CORP.

Anavex clarifies that the January 2022 clinicaltrials.gov update was not real-time and does not reflect late endpoint/phase changes.
AVATAR Phase 3 endpoints were updated per ICH guidelines and approved by UK MHRA and Australian HREC before the study.
Based on AVATAR Phase 3 and prior Phase 2 success, Anavex plans to meet with FDA to discuss approval pathway for blarcamesine in Rett.
No FDA-approved drugs for Rett syndrome; blarcamesine has Fast Track, Rare Pediatric Disease, and Orphan Drug designations.

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