Positive Long-Term Follow-Up Data from Sunstone Therapies’ Investigator-Initiated Phase 2 Study Assessing the Compass Pathway CMPS Synthetic psilocybin COMP360 paired with psychological support in cancer patients with major depressive disorder (MDD) is out.
Relief from depression was achieved in 57% of patients at 18 months following administration of a single dose of 25mg psilocybin paired with psychological support, and 64% had a robust clinical response.
The original Phase 2 trial was completed in 2021 (see Results). Now, this 18-month follow-up data is believed to be the longest follow-up study of psilocybin therapy with cancer patients to date.
See also: Link between cancer and psilocybin: research on this palliative promise
The study assessed a single, fixed dose (25mg) of COMP360 in 30 patients with both curable and incurable cancer. Cohorts of 3 to 4 patients were given the psychedelic in a one-on-one therapist/patient ratio, as well as a prior group preparation session and two group integration sessions complemented by individual therapy. Participants were assessed 8 weeks after dosing.
A total of 28 of the 30 study groups enrolled in the study assessed the effects at 18 months. Of those, 18 patients (64%) demonstrated a sustained clinical response for a period of one and a half years, while 16 patients (57%) showed a reduction in depression.
These results, as measured by MADRS scale values, demonstrated a single dose of psilocybin therapy with psychological support to dominantly induce either strong beneficial effects or direct remission from depression in patients with cancer and MDD.
“This pioneering study is the first of its kind conducted within a community hospital cancer center,” said Dr. Manish Agarwal, CEO of Sunstone and PI of the trial. “The results show long-term improvement in these patients’ depression symptoms and, if replicated in larger studies, could open the door to wider and faster adoption of psilocybin therapy in the future.”
CMO Dr. Paul Thambi echoed that view, adding that the long-term data reinforces the potential of the psilocybin therapeutic approach.
On behalf of Compass, CMO Dr. Guy Goodwin says the study is “extremely encouraging” and “demonstrates the potential sustainability of COMP360 psilocybin therapy,” which the company is pursuing in its Phase I study focusing on treatment-resistant depression (TRD). 3 is doing the evaluation in the program.
Photo: Edit Benzinga with photos by Pexels.