FREE001 is an investigational product combining ketamine and temsirolimus for use in patients with treatment-resistant depression.
Photo courtesy FDA Facebook page
The U.S. Food and Drug Administration has notified Freedom Biosciences that it may proceed with its FREE001-TRD-201 study for its lead program, FREE001, the company said.
FREE001 is an investigational product combining ketamine and temsirolimus for use in patients with treatment-resistant depression (TRD).
Freedom Bio noted the company will initiate its Phase 2a clinical trial in the first half of this year.
“FREE001 builds on new ideas about brain mechanisms that limit the duration of ketamine efficacy,” said John Krystal, M.D., co-founder and chief scientific advisor and the chair of psychiatry at Yale University. “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.”
FREE001 is being developed as an adjunctive treatment in adults with TRD who have an inadequate response to at least two antidepressant treatments.
The main objectives of the Phase 2a dose-ranging evaluation study are to evaluate the safety/tolerability, PK and efficacy of FREE001 in adults with treatment-resistant depression, according to the company.
Freedom Biosciences describes itself as “a Yale spin-out and clinical-stage biotechnology platform developing next-generation neuropsychiatric therapeutics.” Co-founded by John Krystal and Dina Burkitbayeva, founder of PsyMed Ventures, the company’s executive team includes Dr. David Hough, chief medical officer, who led Spravato development at Janssen.