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Largest Phase 3 Clinical Trial on Psilocybin Gets Underway

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Researchers from Compass Pathways PLC (NASDAQ: CMPS) have commenced the largest-ever phase 3 clinical trial investigating the effectiveness of psilocybin against depression. The mental health company first announced the phase 3 program in late 2022 during an online Capital Markets Day.

Compass Pathways’ phase 2b study on the therapeutic potential of psilocybin against depression provided encouraging results and allowed the company to move forward with the next phase of research. Like the recently commenced phase 3 trial, the phase 2b study made history as the largest double-blind, controlled and randomized study of psilocybin therapies.

It showed that patients with depression could experience a “significant reduction” in the symptoms of depression within three weeks of taking a single COMP360 psilocybin dose. This phase of research was designed to grant scientists a deeper understanding of the safety and efficiency of a single 25 or 10 mg COMP360 psilocybin dose compared to a 1 mg dose of a conventional depression treatment.

A few months after the completion of this phase, Compass Pathways announced that it was scheduled to begin the third phase of clinical trials. The ongoing phase 3 clinical trial is now looking into the efficiency, tolerability and safety of using psilocybin as a therapy for treatment-resistant depression.

Psilocybin is part of a group of compounds called hallucinogenics that have recently captured the scientific community’s attention due to their therapeutic potential. After being outlawed for decades, psychedelics have exhibited the potential to treat numerous mental disorders in initial studies.

The research being carried out by companies such as Compass Pathways will potentially pave the way to adopting psychedelic therapies into current mental health treatment protocols. Compass Pathways began recruiting participants for its COMP 005 trial in late 2022 and began tests in January 2023 with 378 participants.

The study is looking to compare the effects of taking a 25 mg dose of synthetic psilocybin alongside psychological support with taking a placebo and is expected to wind down in October 2024. The mental health care company then began enrolling participants for its second COMP 006 study this February.

This study will involve 568 participants taking either 1 mg, 10 mg or 25mg of COMP360 at random with the aim of determining if a second dose of psilocybin can expand the pool of people who reported positive responses in comparison to the phase 2b study.

It is also designed to determine if repeated 10 mg doses of COMP350 can deliver a “meaningful treatment response” and is expected to end by May 2025.

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