Compass Pathways’ stock has crashed by nearly 50% despite the company announcing its Phase III trial of psilocybin had met its primary endpoint in a Phase III trial.
While the British company is hailing the readout as a success, investors seem unconvinced by the impact of the therapy in the study. After a 20 June market close of $4.63, Compass’ stock dropped by 49.24% on 23 June to $2.35 a share after the company reported the data.
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The COMP005 study (NCT05624268) evaluated a placebo against COMP360, a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression. It had a primary endpoint of change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) scores after six weeks.
After a single dose of COMP360 25mg, investigators reported a statistically significant reduction in symptom severity, with a mean treatment difference of -3.6 on the MADRS scale, meeting the primary endpoint.
Safety findings remain consistent with previous studies of COMP360, and there are no new or unexpected safety findings.
The randomised, double-blind study enrolled 258 patients with treatment-resistant depression across the US. Each patient received a single dose of COMP360.
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By GlobalDataA second Phase III study, COMP006, (NCT05711940), of Compass’ psilocybin is expected to read out in H2 2026. This study will evaluate two doses of the therapy.
Compass Pathways CMO Dr Guy Goodwin said: “This progress marks an important milestone for patients living with treatment-resistant depression and highlights the groundbreaking work Compass Pathways is doing to bring innovative treatments to those who have been failed by multiple currently approved available treatment options. This achievement provides hope that they can finally receive appropriate care and live the life they deserve.”
It has been difficult for companies to succeed in the psychedelic space, with no drugs yet approved. Last year, Lykos Therapeutics’ MDMA-based therapy was rejected by the US Food and Drug Administration (FDA), with the agency requesting further studies.
Some of the difficulties in researching these therapies stem from the fact that none are currently approved. Experts have spoken about the complexities of designing a trial for these drugs as they are difficult to placebo control due to functional unblinding.
As a result, sponsors in the space are trying to redesign their studies by using active controls of the investigative drug itself at lower doses.
