New data from a Phase 3 trial will further support a rolling submission for Compass Pathways’ psilocybin treatment COMP360. Patients who saw a clinically meaningful benefit on depression severity maintained response through week 26.
Compass Pathway’s psilocybin treatment worked quickly and durably in patients with treatment-resistant depression during a second late-stage trial, bolstering the psychedelic biotech’s run for an FDA approval.
The new readout “paints a consistent picture” of COMP360’s durability, according to Stifel. The company will submit the data to the FDA to support an ongoing rolling submission for COMP360 in treatment-resistant depression (TRD).
In the Phase 3 COMP006 trial, 39% of patients with TRD who received two fixed doses of COMP360 achieved a clinically meaningful reduction in depression severity by week six, according to Compass’ Tuesday release. The patients who saw relief maintained a durable response through week 26. At entry to the trial, these patients had depressive episodes lasting over three years on average.
Of the patients who achieved the initial meaningful response at week six, 30% later went into remission, Compass said.
The company had already revealed week six data in February showing clinically meaningful results. Today’s update provides a long-term look at how patients fared after their initial doses.
A quarter of patients who received one dose achieved a clinically meaningful response. Compass said that the readout confirms the value of adding a second dose for some patients.
The results appear to be “incrementally better” than what was seen in the earlier COMP005 study, according to Stifel.
Safety was comparable to previous studies, with treatment-emergent adverse events that were transient and typically occurred on the day of dosing. However, the readout did disclose a suicide in a patient who had received Compass’ treatment. This was deemed by the investigator to be unrelated to the therapy, as the death took place 80 days after dosing, Stifel noted. The firm said that there were at least three suicides during clinical testing for Johnson & Johnson’s ketamine treatment Spravato.
“While obviously very unfortunate, we don’t view this as concerning for ‘360 and deaths do happen in TRD programs as TRD can be a fatal condition,” Stifel wrote.
The data collected to date supports the potential for COMP360 to usher in “a profound shift in mental health care,” Compass CEO Kabir Nath said in a statement. COMP360 could allow patients to receive just a few doses per year, rather than staying on chronic, daily treatment, he explained.
Compass expects to complete the rolling submission in the fourth quarter, with a launch anticipated in the first half of 2027 if approved.
Analysts have been bullish on COMP360’s success, with Jefferies “75-85%+ confident” in an FDA approval, according to a June 22 note. The firm anticipates peak sales of $1.5 billion for the therapy.
The drug will face some stiff competition, as Big Pharma in recent years has reengaged with the neuropsych space, but Jefferies is confident that psychedelics players like Compass and rival Definium Therapeutics can carve out a piece of the market.
“We believe the large depression market has historically proven it can support multiple new $1B+ blockbusters (e.g. Caplyta, Auvelity, Spravato, Vraylar), leaving ample room for both COMP360 and [Definium’s] DT120 as well as other psychedelic players,” Jefferies wrote. “Net-net, we do not necessarily foresee psychedelics competing against one another (albeit the availability of rooms may be a gating factor), but rather against existing drugs like SSRIs and antipsychotics (chronic dosing), which offer modest efficacy yet have safety liabilities.”
