Freedom Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has notified the Company that it may proceed with its FREE001-TRD-201 study for its lead program, FREE001, a ketamine-based combination therapy for the treatment of treatment-resistant depression (TRD). Freedom Bio will initiate its Phase 2a clinical trial (the "Study") in the first half of this year. This milestone marks a significant step forward in the development of FREE001, which has the potential to address a critical unmet medical need in patients suffering from TRD.
John Krystal, M.D., Co-founder and Chief Scientific Advisor and the Chair of Psychiatry at Yale, commented "FREE001 builds on new ideas about brain mechanisms that limit the duration of ketamine efficacy. Extending the duration and perhaps magnitude of ketamine efficacy could improve the safety, reduce patient burden of care, and expand access to this important treatment."
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