Compass Pathways recently announced positive topline results for COMP360 (psilocybin), from the largest clinical trial to date, in conjunction with psychological support from specially trained therapists, for treatment-resistant depression (TRD). GlobalData, a leading data and analytics company, believes that this clinical trial demonstrates the potential of psilocybin to become a breakthrough therapy for TRD if safety concerns are resolved in later stage clinical trials.

Philippa Salter, Neurology Analyst at GlobalData, comments: “Approximately a third of patients with depression fail to respond to available antidepressant therapies and are referred to as having TRD. The positive efficacy results from Compass’ trial indicate that psilocybin has the potential to address the significant unmet need for therapies targeting this group of patients. Furthermore, COMP360 was able to demonstrate significant effect only a day after administration. The drug demonstrated a rapid onset of action, which is of particular benefit for patients with severe depression, as other antidepressants normally take several weeks of treatment before an effect is seen.”

Even before the results of this trial were announced, key opinion leaders interviewed by GlobalData said they were excited by the potential impact psychedelics, such as psilocybin, could have on the treatment of depression. In particular, they felt this novel way of treating the disorder could lead to shorter term treatment with lasting benefits, which would be hugely beneficial for patients who currently rely on maintenance treatments with a high pill burden.

Despite the positive results, the trial results raised important concerns surrounding the safety of psilocybin, with reports of suicidal behavior/ideation in a few of the trial participants.

Salter continues: “Suicide is particularly prevalent in patients with more severe depression such as those with TRD. Therefore, any therapy that has the potential to increase suicidal ideation/behavior, particularly in a vulnerable population, carries significant concern.

“However, it should be noted that since suicidal behavior is common in patients with TRD, further investigation will be required to determine whether the adverse effects seen were due to the psilocybin or the disease itself. The outcome of a larger Phase III trial will be vital in determining the safety of psilocybin and whether the benefits will outweigh the risks in such a hard-to-treat patient population.”