COMPASS Pathways announce positive results in clinical trial for treatment-resistant depression

pharmafile | November 10, 2021 | News story | Research and Development  

COMPASS Pathways, a mental health care company dedicated to the acceleration of patient access to evidence-based innovation in mental health, have announced positive top-line results from its Phase IIb clinical trial of COMP360 psilocybin therapy. COMP360 psilocybin therapy uses the active ingredient in ‘magic mushrooms’ to help those living with treatment-resistant depression (TRD).

COMP360 received FDA Breakthrough Therapy designation in 2018. Results from the clinical trial of COMP360 psilocybin combined with psychotherapy demonstrated significant reduction in depressive symptom severity, providing a rapid and durable treatment response to TRD. All patients discontinued antidepressants prior to participation.

The trial was the largest ever study of psychedelics used with psychotherapy. A 25 mg dose significantly reduced severity of depressive symptoms after 3 weeks, with rapid and durable treatment response.

Depression that isn’t helped after two or more adequate anti-depressive treatments is referred to as treatment-resistant depression. The TRD population is more difficult to treat and more likely to relapse than patients with major depressive disorder. The data offers a renewed hope in treatment options for TRD, a disease that affects almost 100 million globally.

COMP360 showed durability at 3 and 6 weeks, a key point in moving into Phase III clinical trials. The results provide the foundation for COMPASS to advance into Phase III clinical trials with COMP360, and are a significant milestone for the psychedelic-assisted treatment industry.

Michael Pollock, CEO at the Depression and Bipolar Support Alliance (DBSA), said: “Many people suffering with severe forms of depression find that existing treatments don’t work for them. We support any attempt to investigate alternative therapies. The approach of cycling through drugs that aren’t working is inadequate for anyone who is living with a mental health condition and disheartening for the family members and healthcare professionals who care for them. The results seen from this study are an early indicator of hope for those who are desperately in need of help.”

Ana Ovey

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