Arya News - Compass has already submitted for approval of its psilocybin-based therapy to the FDA following previous Phase III success.
Compass Pathways’ psilocybin-based therapy has continued to show benefit after six months in a Phase III trial in treatment-resistant depression (TRD).
Following on from six-week data previously announced in February 2026, COMP360, a synthetic, proprietary formulation of psilocybin, demonstrated rapid onset and durable response to at least six months, with a generally well-tolerated and safe profile in people living with TRD.
The COMP006 trial (NCT05711940) enrolled patients with current depressive episodes lasting, on average, over three years and an average of more than six lifetime depressive episodes.
Within the context of this severe population, 39% of patients in the 25 mg arm achieved a clinically meaningful reduction in Montgomery-Åsberg Depression Rating Scale (MADRS) (≥ 25%) by week six, following two fixed doses of COMP360. Patients also maintained a durable response at least through week 26. Of those, nearly 30% later went into remission following the 26-week treatment period.
This compares favourably to the 25% in COMP005 – the first Phase III trial – following a single dose, supporting the potential value of a second dose in enhancing clinical benefit for some patients.
COMP360 continues to demonstrate a generally well-tolerated and safe profile, with the vast majority of treatment-emergent adverse events (TEAEs) being transient and predominantly occurring on the day of dosing.
Compass has already submitted a New Drug Application (NDA), and an initial review with the US Food and Drug Administration (FDA) is underway, with the final submission on track to be completed in Q4 2026.
Compass anticipates the launch of COMP360 in the first half of 2027, subject to FDA approval and following Drug Enforcement Administration (DEA) rescheduling.
Dr Tobias Marton, CMO of Mindful Health Solutions, a US outpatient psychiatry group, said: “The latest results from Compass’ COMP006 Part B mark an important step towards bringing a novel class of therapeutics to the many patients in need. The patients enrolled in Compass’ trial had a high degree of treatment resistance reflected by a current episode length of more than three years on average and a history of over six lifetime episodes. These results are exciting. For us, this represents a significant advancement for psychiatry that will strengthen our ability to reduce the suffering and improve the lives of some of our sickest patients.”
The data from February 2026 led to a 31% jump in Compass’s stock . The latest data has not been met quite as favourably, with the company’s stock dropping 8.3% at market open on 7 July at $11.77 from a 6 July close of $12.84.
In April this year, US President Donald Trump signed an executive order (EO) to expedite regulatory timelines of psychedelics that have already received breakthrough therapy designation or have completed a Phase III trial.
Trump’s directive also places a key focus on psychedelic research, meaning the FDA will work in tandem with the Department of Health & Human Services (HHS) to boost psychedelic clinical trial participation, while allocating $50m to fund further research into the drug class.
Dr Hans Eriksson, CMO of HMNC Brain Health, previously told that psychedelic medicines show great promise in the realm of psychiatry – potentially offering patients treatment durability not previously observed with traditional therapies on the market.
"Compass’ psilocybin shows six-month durability in Phase III trial" was originally created and published by Clinical Trials Arena , a GlobalData owned brand.
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