Psychedelics have long been heralded for their numerous benefits, with recent studies showing that these substances may be useful in the treatment of various mental health conditions.
These benefits have increased interest in these substances, with Compass Pathways PLC (NASDAQ: CMPS) recently announcing that the company plans to begin a phase 3 human trial, which will investigate the effectiveness psilocybin in treating depression this year. This will be the first human trial of this magnitude involving psychedelic therapy globally.
Compass Pathways is a mental healthcare company focused on transforming patient experiences in mental healthcare. The company has developed a psilocybin therapy known as COMP360 and is working to obtain approval from the Food and Drug Administration for the therapy by the end of 2025.
The trial comes after the company released successful results from its phase IIb trial, which was conducted in late 2021. The trial involved patients suffering from treatment-resistant depression who receive different doses of psilocybin. The trial was conducted over a 12-week period, with patients in different groups receiving 1 mg, 10 mg and 25 mg doses of psilocybin as part of their treatments.
The researchers observed significant improvements in measures on a depression scale after one 25 mg dose of psilocybin was administered, in comparison to the other dose groups. In their report, the researchers noted that 11 patients in the 10 mg and 25 mg groups experienced severe adverse reactions during the follow-up period. These reactions include suicidal behavior and suicidal ideation. In a statement, the company noted that it wasn’t clear whether these events were causally associated with the psilocybin therapy.
The phase III trial will be divided into two clinical trials and a long-term follow up. The first phase of this trial, which will enroll 378 participants, will compare the effectiveness of one 25 mg psilocybin dose to that of placebo. The company’s chief medical officer, Guy Goodwin, stated that using a placebo would shed light on the safety profile of the COMP360 therapy.
The objective of the second phase of the trial will be to explore the effectiveness of a second dose of psilocybin that is administered to participants three weeks after the administration of the first dose. This phase plans to enroll 568 participants. Participants will be required to undergo a psychotherapy session both before and after the psychedelic drug’s administration.
It should be noted that this phase III trial solely targets patients suffering from severe depression who haven’t benefited from current treatments such as antidepressants or psychotherapy.
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