The US Food and Drug Administration (FDA) has approved Freedom Biosciences’s investigational new drug (IND) application for FREE001, enabling the commencement of its Phase IIa clinical trial of the ketamine-based combination therapy for treatment-resistant depression (TRD).
The trial, known as FREE001-TRD-201, is set to commence in the first half of this year and represents a significant advancement in addressing the unmet medical needs of TRD patients.
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FREE001, the company’s lead programme, combines ketamine with temsirolimus and is being developed as an adjunctive therapy for adults with TRD who have not responded adequately to at least two antidepressant treatments.
The Phase IIa dose-ranging evaluation study will assess the safety, tolerability, pharmacokinetics (PK), and efficacy of FREE001 in adults with TRD.
Clinical evidence has increasingly supported the antidepressant effects of ketamine. Notably, the S (+) enantiomer of ketamine, esketamine (SPRAVATO), received approval from the FDA in March 2019 for TRD.
In a study involving 20 patients with major depression, those pre-treated with oral sirolimus, a rapamycin complex 1 (mTORC1) inhibitor, showed a significant prolongation of ketamine’s antidepressant effects compared to placebo.
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By GlobalDataThis finding suggests that mTOR inhibitors like temsirolimus, the prodrug of sirolimus, could extend the treatment effects of ketamine by two to three weeks.
Such an extension could reduce the cost and resource burden of ketamine treatments, improve patient convenience and adherence, and potentially decrease adverse events due to less frequent dosing.
Freedom Biosciences was co-founded by Yale University psychiatry chair and co-founder and chief scientific adviser Dr John Krystal and PsyMed Ventures founder Dina Burkitbayeva.
Krystal said: “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.”
