Positive long-term follow-up data from Sunstone Therapies’ investigator-initiated Phase 2 study assessing COMPASS Pathways’ (NASDAQ:CMPS) synthetic psilocybin COMP360 paired with psychological support in cancer patients with Major Depressive Disorder (MDD) is out.
57% of patients sustained remission of depression, and 64% a robust clinical response, at 18 months following administration of a single 25mg psilocybin dose paired with psychological support
The original Phase 2 trial was completed in 2021 (see results). Now, this 18-month follow-up data is believed to be the longest-term follow-up study of psilocybin therapy with cancer patients ever completed.
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 curable and incurable cancer. Cohorts of 3 to 4 patients were administered the psychedelic in a one-on-one therapist/patient ratio, plus one prior group preparation session and two group integration sessions supplemented by individual therapy. Participants were evaluated at 8 weeks post-dose.
28 out of the total 30 study cohort enrolled in the study assessing effects at 18 months. Of those, 18 patients (64%) demonstrated sustained clinical response for the year and a half period, while 16 patients (57%) showed remission of depression.
Measured by the MADRS scale values, these results showed a single dose of psilocybin therapy together with psychological support majoritarily induced either strong beneficial effects or straight out 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,” Sunstone’s CEO and the trial’s PI Dr. Manish Agrawal stated. “The results show significant improvement in these patients’ depression symptoms long-term and, if replicated in larger studies, could open the door to a wider and faster adoption of psilocybin therapy in the future.”
CMO Dr. Paul Thambi echoed that vision, 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 durability of COMP360 psilocybin therapy,” which the company is assessing in its Phase 3 program focusing on Treatment-Resistant Depression (TRD.)
Photo: Benzinga edit with photo by Pexels.