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Lead 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.

Development Programmes

1

FREE001 (Ketamine + Temsirolimus)

Ketamine
Phase II
Treatment-Resistant Depression (TRD)

Treatment-resistant depression — IV ketamine combined with mTOR inhibitor temsirolimus to extend antidepressant response from ~2-7 days to ~14+ days

Programme Tracker

Treatment-Resistant Depression (TRD)

Primary: US (FDA)
Phase IIActive

Phase 2a dose-ranging trial underway (~100 patients) since H1 2024. FDA IND approved April 2024. Data readout expected ~2026. Yale spinout co-founded by Dr. John Krystal (Chair of Psychiatry, Yale). Total funding ~$10.5M.

Milestones

Phase II started

Completed

Actual: Jun 1, 2024

Phase 2a dose-ranging study initiated (~100 patients)

Why it matters: Trial enrollment begun — evaluating safety, tolerability, PK, and efficacy signals across dose ranges. ~100 patients is a substantial Phase 2a for an academic spinout, suggesting confidence in the mechanism.

Watch next: Enrollment completion and first efficacy data

Regulatory review accepted

Completed

Actual: Apr 1, 2024

FDA approved IND application for FREE001-TRD-201 Phase 2a in treatment-resistant depression

Why it matters: IND clearance validates the combination approach (ketamine + mTOR inhibitor) as safe enough for human trials. If temsirolimus extends ketamine's antidepressant effects from ~1 week to ~2+ weeks, it would reduce the frequency of IV infusions — the main practical barrier to chronic ketamine treatment for TRD.

Watch next: Phase 2a data readout expected ~2026

Funding milestone

Completed

Actual: Aug 1, 2022

Emerged from stealth with $10.5M seed financing

Why it matters: Freedom Biosciences is a Yale spinout co-founded by John Krystal (Chair of Psychiatry, Yale — one of the world's foremost ketamine researchers) and Dina Burkitbayeva (PsyMed Ventures). The $10.5M seed funds the Phase 2a programme. The scientific premise is validated by Yale academic data (NCT02487485) showing mTOR inhibition extends ketamine's antidepressant window.

Recorded Events

Jun 1, 2024: Phase II started

Apr 1, 2024: Regulatory review accepted

Aug 1, 2022: Funding milestone

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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