Freedom Biosciences, Inc. ("Freedom Bio" or the "Company") has received notification from the U.S. Food and Drug Administration (FDA) greenlighting the initiation of its FREE001-TRD-201 study, a Phase 2a clinical trial for FREE001, a novel ketamine-based combination therapy designed to tackle treatment-resistant depression (TRD). This development marks a significant stride forward in addressing the urgent medical need for effective TRD treatments.

FREE001, a combination of ketamine and temsirolimus, is aimed at adults grappling with TRD, particularly those who haven't responded adequately to at least two antidepressant treatments. The primary objectives of the Phase 2a trial include assessing the safety, pharmacokinetics (PK), and efficacy of FREE001 in this patient population.

Dr. John Krystal, M.D., Co-founder and Chief Scientific Advisor of Freedom Bio and Chair of Psychiatry at Yale, highlighted the innovative approach of FREE001, which targets brain mechanisms to potentially extend the efficacy of ketamine. By prolonging and enhancing ketamine's effects, there's a prospect of improving treatment safety, reducing patient burden, and broadening access to this vital therapy.

Major depressive disorder (MDD) poses a significant challenge due to its chronic nature and limited treatment options. In the United States alone, millions of adults suffer from MDD, with a considerable portion experiencing TRD, which amplifies the disorder's burden on individuals and society. Despite various available therapies, a substantial number of patients fail to achieve remission, leading to prolonged suffering and diminished quality of life.

Ketamine has emerged as a promising treatment for depression, with studies demonstrating its efficacy and tolerability. The addition of temsirolimus aims to extend ketamine's antidepressant effects, potentially offering relief for up to several weeks. This extension could lead to numerous benefits, including reduced healthcare costs, improved patient adherence, and fewer adverse events, ultimately enhancing the overall treatment experience for individuals battling TRD.

 

Source: prnewswire.com

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