Atai Life Sciences announced the initiation of its Phase 2b proof-of-concept clinical trial for RL-007 for Cognitive Impairment Associated with Schizophrenia, a condition for which there are currently no FDA-approved treatments. The Phase 2b trial is a randomized, placebo-controlled, double-blind, 3-arm study evaluating 2 doses of RL-007 and a placebo among 234 patients. The trial includes a 6-week treatment period with the MATRICS Consensus Cognitive Battery as the primary endpoint. The MCCB has been supported by the FDA as an approvable endpoint for CIAS. The trial will be conducted in the U.S., and patient screening is currently underway.
Published first on TheFly
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