Compass Pathways' psilocybin drug shows 39% response rate in Phase 3 trial

Key Takeaways:

39% of patients on COMP360 achieved clinically meaningful depression reduction by week 6
Response was durable through week 26, supporting a rolling FDA submission
Compass targets a US launch in the first half of 2027, pending approval

Compass Pathways Plc said 39% of patients with treatment-resistant depression who received two fixed doses of its synthetic psilocybin therapy COMP360 achieved a clinically meaningful reduction in symptoms by week six, with benefits lasting through week 26 in a second Phase 3 trial.

"The data confirm that COMP360 can be both a very rapid acting and a durable treatment for individuals who suffer from depression," Chief Executive Officer Kabir Nath said during an investor update. The company expects to complete its rolling submission to the US Food and Drug Administration in the fourth quarter.

The COMP006 trial tested 1 mg, 10 mg and 25 mg doses of COMP360 administered three weeks apart in patients whose current depressive episodes had lasted more than three years on average. Of the patients who achieved a meaningful response at week six, 30% later went into remission. The results compare favorably with the earlier COMP005 study, where 25% of patients responded after a single dose, suggesting a second dose may benefit some patients.

Compass is pursuing a potential US launch in the first half of 2027, subject to FDA approval and Drug Enforcement Administration rescheduling. Jefferies analysts said they are 75% to 85% confident in approval, with peak sales estimated at $1.5 billion. Evercore ISI upgraded the stock to Outperform from In Line with a $21 price target, implying 50% upside from current levels. The stock has surged 304% over the past year.

Safety data showed COMP360 was generally well tolerated, with adverse events including headache, nausea and hallucination that were transient and occurred on the day of dosing. One suspected suicide in the 25 mg arm was deemed by the investigator unrelated to treatment, occurring 80 days after dosing. Chief Medical Officer Dr. Guy Goodwin said suicidality events were low and evenly distributed across treatment arms.

Chief Commercial Officer Lori Englebert said Compass sees a US population of about 4 million patients with treatment-resistant depression. She contrasted COMP360's potential dosing profile with Johnson & Johnson's Spravato, which requires 20 to 28 doses over six months under its label. Compass expects real-world use could average roughly two to four doses per patient per year.

The positive data strengthens Compass' position in the neuropsychiatry market, where Big Pharma has recently reengaged. If approved, COMP360 would be the first classical psychedelic therapy cleared by the FDA. Investors will watch for completion of the rolling submission in the fourth quarter and the DEA rescheduling process, which are the next key catalysts for the stock.

This article is for informational purposes only and does not constitute investment advice.