Compass points to strong psilocybin data in depression
Psychedelic drug developer Compass Pathways is preparing to talk to the FDA about filing its psilocybin therapy COMP360 for approval in treatment-resistant depression (TRD), after reporting positive results in a pair of phase 3 trials.
Shares in Nasdaq-listed Compass were up around a third following the announcement of the data, which the company said show "a level of clinical effect that has historically been extremely difficult to achieve in TRD."
The latest readout, from the COMP006 study, showed that two doses of the highest, 25mg dose of COMP360, given in a controlled environment with psychological support from a trained therapist, were significantly more effective at reducing symptoms of depression compared to a control based on a 1mg dose of the drug.
Two doses of COMP360 achieved a 3.8-point improvement in symptoms measured using the MADRS scale compared to control, which COMPASS said was a "highly statistically significant" difference.
In addition, 39% of patients treated with COMP360 saw a 25% or greater reduction in MADRS in COMP006, which was also significantly higher than in the control group.
The data reinforce the results of the CPM005 study, for which London, UK-headquartered Compass reported preliminary data last year, including a significant 3.6-point reduction in MADRS after a single dose of COMP360, with a quarter of patients reporting a reduction of 25% or more with durability extending to 26 weeks.
Compass said in 2024 that it had decided to wait until after the 26-week data endpoint for both trials – the COMP006 result is due in the third quarter – before seeking FDA approval, saying it was hoping to avoid FDFA concerns about "functional unblinding" – where patients will likely know if they received the active study drug rather than a control due the obvious psychedelic effect.
That emerged as an issue when the FDA turned down Lykos' MDMA-based drug midomafetamine for post-traumatic stress disorder (PTSD), and Compass is hoping that the longer follow-up period will assuage those concerns.
Now, with 26-week data for COMP005 in hand, the company said it hopes to discuss a rolling submission for COMP360 with the FDA, which could allow some of the dossier to be filed early and updated when the longer-term COMP006 follow-up results become available.
Compass chief executive Kabir Nath called the new data "a remarkable achievement for the field of psychiatry, especially in the TRD population, where proving benefit has historically been extraordinarily challenging."
He added that the results "strengthen our conviction in the highly differentiated profile for COMP360," and the company is now working towards a goal of filing the psychedelic for approval before the end of the year.
Approximately 100 million people in the world live with TRD, which means they have not responded to at least two antidepressant treatments for their major depressive disorder (MDD). There are around 5 million patients in the US who could potentially benefit from this form of treatment.
The results come shortly after researchers in the UK reported positive phase 2a results with Helus' synthetic dimethyltryptamine (DMT) psychedelic, SPL026, in moderate-to-severe MDD.
