Great news for those researching new treatments for depression in cancer patients! Positive long-term follow-up data has just been released from Sunstone Therapies investigator-initiated Phase 2 study evaluating synthetic psilocybin COMPASS Pathways, with some rather promising results.
Administration of a single 25 mg dose of psilocybin combined with psychological support resulted in 57% of patients sustaining remission of depression, with 64% experiencing a robust clinical response 18 months later.
Surprisingly, this data is believed to be longer-term follow-up, adding further support to the already impressive results from the original Phase 2 study completed in 2021.
Sunstone completed the Phase 2 study in 2021 and this year published its findings in JAMA Oncology.
The study involved 30 patients, both curable and incurable, who were given a fixed dose of 25mg of COMP360 psilocybin. Each cohort of patients was administered the drug in a one-on-one therapist/patient relationship, with an additional group preparation session and two group integration sessions supplemented by individual therapy. Study results were evaluated 8 weeks after dosing, with promising indications that patients experienced a reduction in anxiety and depression.
Of the total 30 patients who participated in the study, 28 completed the 18-month evaluation. Among these 28, 18 patients (64%) maintained a positive response during the entire 18-month period, while 16 patients (57%) experienced remission of depression.
In cancer patients with major depressive disorder, a single dose of psilocybin therapy with psychological support showed mostly strong beneficial effects or complete remission from depression based on MADRS scores.
According to Guy Goodwin, Chief Medical Officer of COMPASS Pathways, this study conducted by Sunstone Therapies is extremely encouraging and demonstrates the potential longevity of COMP360 psilocybin therapy. COMPASS Pathways is examining the long-term effects of COMP360 in our Phase 3 program in treatment-resistant depression.
What makes this study promising is that it shows that COMP360 psilocybin therapy can have long-lasting effects. The use of psilocybin for major depressive disorder, treatment-resistant depression, and other mental health disorders has been an area of growing interest among researchers, and this study could be a major breakthrough in the field of psychedelics. It can also be used to support evidence of the benefits of psilocybin therapy in decriminalization efforts in the United States and around the world.
COMP360 is currently being studied in Compass’ Phase 3 clinical trials for its potential to treat treatment-resistant depression (TRD). Anticipation grips us all as we await the results that, if positive, may be able to propel psychedelic-assisted therapy into a new era of possibility. The two Phase 3 studies have a total of 946 participants, which is a significant milestone in psychedelic medicine research. If these trials are successful, Compass will work with the FDA to potentially approve psilocybin for the treatment of TRD by 2025, fanning the flame of transformation in the mental health and psychedelics fields.
Yes, we all know that Compass Pathways has been the subject of scandals regarding the patenting of a synthetic version of psilocybin. This has certainly caused a certain polarization between the scientific community and that of psychonauts. However, we shouldn’t ignore that the company is one of the most advanced in the industry and as its largest study provides positive data supporting what we already know about magic mushrooms’ potential to cure debilitating diseases, this highly scrutinized company will be one one of the first companies that advanced the psychedelic industry and the public opinion surrounding these substances.
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