Loading ...

A single dose of a synthetic form of psilocybin known as COMP360 (Compass Pathways) is both statistically significant and clinically meaningful in reducing treatment-resistant depression (TRD) in a new phase 3 trial, its manufacturer announced in a press release.

Topline results from the ongoing COMP005 trial showed that a single 25-mg dose of the investigational drug was associated with a greater reduction in symptom severity on the Montgomery-Åsberg Depression Rating Scale (MADRS) at 6 weeks than matching placebo, meeting the study’s primary endpoint.

Additionally, there were “no unexpected safety findings and no clinically meaningful imbalance in suicidal ideation between treatment and placebo arms,” the company added.

This is “the first study of an investigational, synthetic psilocybin, and the first classic psychedelic, to report phase 3 efficacy data,” the company said. 

The results are important for patients with TRD who do not respond to currently approved and available treatment options, Guy Goodwin, MD, chief medical officer at Compass, said in the release.

“This achievement provides hope that they can finally receive appropriate care and live the life they deserve,” Goodwin added.

Ongoing Research

COMP360 is a synthetic and proprietary formulation of psilocybin. 

As reported by Medscape Medical News, results presented at the 2023 European Psychiatric Association Congress from a phase 2 study assessing a single 25-mg dose of the drug were associated with improvements of core symptoms in patients with TRD. It has also appeared to be effective for bipolar depression and for anorexia nervosa in two separate small studies.

COMP005 is the first of two ongoing and parallel-running phase 3 trials assessing the investigational drug. In it, 258 patients with TRD were enrolled across 32 US sites and randomly assigned to receive one administration of either the active drug at a dose of 25 mg or matching placebo. The newly released results are from the first part of the trial, which included blinding through 6 weeks. 

From baseline to 6 weeks, the participants who received the active treatment had a significantly greater reduction in symptom severity on the MADRS compared to those who received placebo (P < .001). In addition, there was a mean score treatment difference of -3.6 (95% CI, -5.7 to -1.5), demonstrating a clinically meaningful reduction, the company noted.

The trial’s data, which were reviewed by an independent Data Safety Monitoring Board, showed no new or unexpected safety findings and were consistent with those from previous COMP360 studies.

Part 2 of the ongoing trial will be evaluating results blinded through week 26, and part 3 will contain open-label treatment from week 26 to week 52.

“We eagerly anticipate further insights once we have the full dataset,” Kabir Nath, Compass’ chief executive officer, said in the release.

For now, the company reported that it is planning to discuss these preliminary results with the US Food and Drug Administration.

In addition, the ongoing phase 3 COMP006 trial is aiming to enroll 568 participants from North America and Europe and will assess two fixed doses of the active treatment. Compass is expecting to receive 26-week data during the second half of 2026. 

All mentioned studies were funded by Compass Pathways.