Psilocybin, a psychedelic derived from mushrooms, has been proven effective as a therapy for treatment-resistant depression (TRD) in the largest study of its kind.
The results of COMPASS Pathways’ Phase IIb trial have been published in The New England Journal of Medicine (NEJM).
The data show that after a single 25mg dose of COMP360 psilocybin, combined with psychological support, 29.1% of participants were in remission by week three.
Dr Guy Goodwin, Chief Medical Officer, COMPASS Pathways, said: “This suggests that COMP360 psilocybin has a true pharmacological effect, a finding that is critical for it to be recognised as a new treatment option in the future.
“We look forward to starting our Phase III programme later this year, moving us closer to providing COMP360 psilocybin with psychological support for patients who desperately need it.”
The trial data
In the Phase IIb trial, 233 patients with TRD received either 1mg, 10mg or 25mg COMP360 psilocybin, in conjunction with psychological support from specially trained therapists.
Patients who received a single 25mg dose of COMP360 psilocybin, in combination with psychological support, experienced a highly statistically significant, rapid reduction in symptoms of depression after three weeks.
Double the number of patients who received a 25mg dose had a sustained response at week 12, compared to those who received 1mg.
Scott Aaronson, Chief Science Officer of the Institute for Advanced Diagnostics and Therapeutics, Sheppard Pratt Health System, and a Principal Investigator on the trial, said: “Over 100 million people around the world suffer with treatment-resistant depression, and haven’t found relief from existing therapies.
“Yet in this study, a substantial number of patients in the 25mg group experienced improvement in their symptoms of depression, with the effects lasting for up to three months.”