Compass Pathways Completes FDA Application for Psilocybin Therapy, Prepares for Launch

Key Points

• Compass Pathways has completed its rolling FDA application for COMP360, its synthetic psilocybin treatment for treatment-resistant depression, supported by Phase 2 and two Phase 3 studies. The FDA has begun reviewing portions, but the timing and outcome of its decision remain uncertain.
• Compass reported that clinical trials showed efficacy as early as 24 hours after treatment and potential benefits lasting up to 52 weeks for some patients. The company says more than 1,000 patients with treatment-resistant depression have received COMP360.
• A commercial launch depends on FDA approval and federal and state rescheduling. Compass aims to be launch-ready by year-end, but expects a gradual rollout and does not anticipate meaningful revenue until late in the second quarter or the third quarter of next year.

Compass Pathways NASDAQ: CMPS has completed its application for U.S. approval of COMP360, its proprietary synthetic psilocybin formulation for treatment-resistant depression, and is preparing for a potential commercial launch, executives said at a company news event.

Chief Patient Officer Steve Levine said the company submitted the new drug application on a rolling basis and that the Food and Drug Administration had already begun reviewing portions of it. The application includes data from two Phase 3 studies supported by a Phase 2 study, he said.

Chief Commercial Officer Lori Englebert said Compass plans to be launch-ready by the end of the year, but cautioned that the timing of approval and subsequent steps remains uncertain. If COMP360 is approved, the company expects a gradual initial uptake as treatment sites complete training and address reimbursement.

FDA review and clinical data

Levine said the company’s studies showed a generally safe and well-tolerated profile and detected efficacy at the first measured time point, 24 hours after administration. Data extending as far as 52 weeks suggest that some patients may experience durable benefits with up to a few administrations over a year, he said.

Englebert said more than 1,000 patients with treatment-resistant depression have received COMP360 and described the efficacy findings across the company’s Phase 2b and Phase 3 trials as consistent. She said the average duration of a depressive episode among trial participants was approximately two to four years.

Compass is using a national priority review voucher, which Englebert said provides for more frequent communication with the FDA and requires the company to respond to information requests within 24 hours. Based on those requests, the company believes the agency has reviewed substantial portions of the application, although the FDA has not confirmed that those reviews are complete, she said.

Englebert said Compass does not know whether it will receive an application acceptance with a target decision date or an approval without one. She noted that other companies using such vouchers have received a target date and then had their applications reviewed earlier.

Launch preparations and reimbursement

Commercialization would require more than FDA approval. Englebert said the Drug Enforcement Administration and individual states would also need to reschedule the product before it could be prescribed. She said approximately 45 states, representing about 93% of the U.S. population, intend to reschedule within 30 days of federal action.

Englebert said she would not expect a meaningful start to revenue until late in the second quarter or the third quarter of next year, subject to the approval and scheduling process. Even with patient demand, she expects an initially slow ramp as providers gain experience and ensure they can be reimbursed for their time.

Compass is preparing a field reimbursement team to help sites with coding and payment, alongside patient assistance and affordability programs. Englebert said the company has not set a price for COMP360 and would consider the value it brings to the health care system and the price of the existing treatment-resistant depression product.

Levine said Category III billing codes for the monitoring period associated with in-office COMP360 administration are already in place. They have not yet become permanent Category I codes, he said. Compass plans to help sites understand which codes they can use and encourage submission of the Category III codes.

The company also expects significant costs associated with a risk evaluation and mitigation strategy, or REMS, and specialty distribution. Englebert said sites, patients and specialty pharmacies would need certification, with compliance tracked and subject to FDA audit.

Existing treatment sites and other programs

Englebert said there are approximately 8,500 sites administering multi-hour treatments such as SPRAVATO, and she expects that number to exceed 9,000 by the time Compass launches. Levine said rooms and staff at such sites could support COMP360, although workers would need training to prepare and support patients during a psychedelic experience.

Levine said most high-volume treatment sites have not participated in clinical trials, but Compass has worked through strategic collaborations representing more than 1,000 sites that currently deliver SPRAVATO.

Asked about a competing psilocybin application from the nonprofit Usona Institute, Englebert distinguished its major depressive disorder patient population from Compass’s treatment-resistant population. She said Compass remains confident in its commercial positioning.

Compass is also conducting a late-stage COMP360 trial in post-traumatic stress disorder involving approximately 300 participants, Levine said. He said the study is designed to potentially support registration based on a single trial, following what he described as encouraging Phase 2 efficacy and tolerability findings.

About Compass Pathways (NASDAQ:CMPS)

Compass Pathways plc is a biotechnology company developing treatments for mental health conditions. Founded in 2016 by George Goldsmith and Ekaterina Malievskaia, the company is focused on advancing psychedelic-based therapies through clinical research. Its lead investigational product, COMP360, is a synthetic formulation of psilocybin being studied alongside psychological support. Compass is evaluating COMP360 primarily as a potential treatment for treatment-resistant depression and has also explored its use for other mental health conditions, including post-traumatic stress disorder.

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