COMPASS Pathways is recruiting participants for its trial investigating the safety and tolerability of its psilocybin formula – COMP360 – for post-traumatic stress disorder (PTSD).
PTSD affects around 3.9% of the world’s population. Treatment for the condition often consists of therapy and antidepressants, however, there is a strong need for innovative care for PTSD as many who receive treatment do not go into remission.
In November 2022, COMPASS published the results of its phase 2b trial of COMP360 psilocybin therapy for treatment-resistant depression (TRD) – the largest study of its kind – in The New England Journal of Medicine (NEJM).
The study investigated the efficacy and safety of a single dose of investigational COMP360 psilocybin (25mg or 10mg), compared to 1mg, in patients with TRD.
COMPASS has stated the results demonstrated that 29.1% of participants with TRD were in remission by week three, following a single 25mg dose of COMP360 psilocybin, in combination with psychological support. Additionally, double the number of patients who received a 25mg dose had a sustained response at week 12, compared to those who received 1mg.
The company has emphasised that this is higher than the response rates seen for equivalent lines of treatment in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study*, a large prospective clinical trial of major depressive disorder conducted to determine the effectiveness of different treatments for depression.
Speaking at the time of the publication of the results, Dr Guy Goodwin, Chief Medical Officer, COMPASS Pathways, stated: “We saw positive results in a particularly difficult-to-treat group of patients, and the highest dose of COMP360 psilocybin had the greatest impact on people’s depression.
“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.”
COMPASS is currently recruiting participants for its Phase 2, open-label study looking at COMP360 for the treatment of PTSD, which is being carried out with King’s College London as part of a multi-centre trial.
Speaking to Psychedelic Health, Goodwin commented: “After seeing positive Phase 2b results for investigational COMP360 psilocybin therapy in treatment-resistant depression, we launched our Phase 2 study in people with PTSD, which is currently ongoing.
“There is a huge need to develop innovations as over 300 million people experience PTSD at some point in their lives, yet only 20 to 30% of patients make a full remission.”
The study is taking place at the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) and participants will receive a single 25mg dose of COMP360 psilocybin. This will be administered in conjunction with specialist psychological support amounting to at least six sessions of talking therapy.
Participants will be followed up for a total of 12 weeks following dosing, during which researchers will be assessing safety along with changes in PTSD symptoms and quality of life. Participants will also have the option to take part in a neuroimaging through the trial.
