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Freedom Biosciences Announces FDA Approval of IND Application for FREE001 in Patients with Treatment-Resistant Depression

Excerpt from the Press Release:

SAN FRANCISCO, April 25, 2024 /PRNewswire/ — Freedom Biosciences, Inc. (“Freedom Bio” or the “Company”), a clinical-stage biotechnology platform focused on developing next-generation neuropsychiatric therapeutics, today 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.”

About the Phase 2a Clinical Trial

FREE001 is an investigational combination product of ketamine and temsirolimus which is being tested for use in patients with treatment-resistant depression (TRD).

FREE001 is being developed as an adjunctive treatment in adults with TRD who have an inadequate response to at least 2 antidepressant treatments. The main objectives of this Phase 2a dose-ranging evaluation study are to evaluate the safety/tolerability, PK, and efficacy of FREE001 in adults with TRD.

Major depressive disorder (MDD) is a debilitating and chronic condition with limited effective treatment options. MDD is one of the most common mental health disorders in the United States (US), with an estimated 21.0 million adults (8.3% of all adults) having at least 1 major depressive episode in 202013. MDD also impacts physical health, worsens outcomes of other medical conditions, and, on average, results in a 10-year reduction in life expectancy14.

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