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Research, Drug Development & ManufacturingLead program: Phase II

Freedom Biosciences

New Haven, CT / Yale University spin-out, USA, United States
1 Drug Candidate

Freedom Biosciences is a Yale University spin-out developing next-generation combination therapies for treatment-resistant depression. Co-founded by Yale psychiatry chair Dr. John Krystal (CSO) and Dina Burkitbayeva (CEO, PsyMed Ventures), the company raised $10.5M seed financing in August 2022. Its lead asset FREE001 combines ketamine with temsirolimus (an mTOR inhibitor and prodrug of sirolimus) to extend the antidepressant duration of ketamine from the standard 2–7 days to approximately 14 days. FDA cleared the IND for the Phase 2a study in April 2024, and the trial (FREE001-TRD-201, n≥100) is underway.

Drug Pipeline

1

FREE001

Ketamine
Phase II
Treatment-Resistant Depression (TRD)

Treatment-resistant depression (TRD). Combination of IV ketamine + temsirolimus (oral mTOR inhibitor). Preliminary Phase 2 data show temsirolimus extends ketamine antidepressant effects to ~14 days vs 2–7 days for ketamine alone (n=23 proof-of-concept). FDA IND cleared April 2024. Phase 2a study FREE001-TRD-201 (n≥100) underway; estimated completion ~2026–2027. 505(b)(2) regulatory pathway leveraging existing FDA approvals for both components. Co-developed with Yale (Dr. John Krystal).

Quick Facts

Type
University Spinout
Founded
2022
Lead Stage
Phase II
HQ
New Haven, CT / Yale University spin-out, USA, United States
Website
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