COMPASS Pathways: Positive Psilocybin Trial, High-Dose Group Improves Beyond Depression Reduction

As COMPASS Pathways CMPS crunches more data from a recent trial investigating psilocybin therapy for treatment-resistant depression (TRD), findings show that a higher dose of 25mg (compared to 1mg and 10mg) occasioned an increase in positive feelings of interest in life and a decrease in negative feelings of distress and fear.

COMPASS’ phase IIb clinical trial results are a product of the company’s focus since 2018 when it received FDA “breakthrough therapy” designation for its COMP360 psilocybin treatments for TRD. The distinction of breakthrough therapy is meant to expedite the development and review of new drug formulations for serious or life-threatening conditions.

Globally, an estimated 100 million people suffer with TRD and do not respond to existing therapies.

The objective of the Phase IIb trial by COMPASS was to find the appropriate dose of psilocybin for a larger, pivotal phase III program. The trial was the largest randomized, controlled, double-blind psilocybin therapy study ever conducted, including 233 patients from 10 countries in North America and Europe. Of the trial participants, 94 percent had no prior experience with psilocybin.

The study showed that at least twice the number of patients in the 25mg group showed response and remission at week 3 and week 12, compared with the 1mg group. It also showed steady improvement in quality of life, daily functioning and cognition.

“Our additional analyses underline the robustness of our findings that a single high dose of COMP360 psilocybin, given in conjunction with psychological support, led to a rapid and sustained response for many patients,” said Prof. Guy Goodwin, chief medical officer for COMPASS Pathways. “Additionally, we observed consistent improvement in measures of anxiety, positive and negative affect, quality of life, daily functioning, cognition, and self-reported depression.”

Using the Positive and Negative Affect Schedule (PANAS), a scale that measures positive/negative affect and the propensity to experience positive emotions and interact with others positively, even through life’s challenges, patients exhibited meaningful changes. In the 25mg group, in surveys taken on the day after COMP360 administration and at the questionnaire’s final administration at week 3, patients had a higher increase in positive affect (feeling interested, excited and strong) and a greater decrease in negative affect (feeling distressed, upset and afraid).

Goodwin said the results could make a tremendous difference to patients suffering from treatment-resistant depression, who have few options available to them. He highlighted the fact that one-quarter of the 25mg group maintained a consistent response 12 weeks after a single administration with no other antidepressant medication. “This finding in itself is unprecedented,” he said.

The company noted that durability – or the longevity of lasting effects – is being looked at in a one-year follow-up study which is currently underway.  

COMPASS expects to begin its phase III trial of COMP360 for TRD in 2022.

Price Action:

Shares of COMPASS were trading 2.00% higher at $33.86 per share at the time of this writing early Wednesday afternoon.