2024 is poised to be a pivotal year for the psychedelics sector.
Lykos Therapeutics (formerly MAPS Public Benefit Corporation) is on track to secure US Food and Drug Administration (FDA) approval for MDMA-assisted therapy for post-traumatic stress disorder, having announced earlier this month the FDA acceptance and priority review of its new drug application.
The application was assigned a Prescription Drug User Fee Act target action date of August 11, 2024, and, if approved, would mark the first MDMA-assisted therapy and psychedelic-assisted therapy in the US.
Meanwhile, other biotechnology firms are progressing their own innovative psychedelics-based treatments for a range of conditions with unmet needs including treatment-resistant depression and opioid use disorder into mid and late-stage clinical trials.
At this exciting time in the psychedelics space, Proactive has rounded up the top five trials to watch as the year unfolds.
Compass Pathways: synthetic psilocybin for treatment-resistant depression
London, UK-based Compass Pathways (NASDAQ:CMPS) is expected to report topline data from its global late-stage clinical program evaluating its synthetic psilocybin COM360 in conjunction with psychological support targeting treatment-resistant depression (TRD) in 2024.
The program is made up of two trials. The COMP 006 trial arm is examining the effects of three different doses of COMP360 whereas the US-based COMP 005 trial is examining the effect of a single 25mg dose compared to a placebo.
The Phase 3 program results are highly anticipated as they are expected to build on positive outcomes from Compass’ Phase 2b study of COMP360 in TRD, with Compass intending to apply for FDA approval upon completion of these clinical trials.
In the Phase 2b trial, a single, 25mg dose of COMP 360, designed as a breakthrough therapy by the FDA, resulted in a statistically significant reduction in depressive symptoms in TRD patients after three weeks.
Ahead of the trial results, Compass in January 2024 entered into a research collaboration with Greenbrook TMS to inform the delivery model design of COMP360 psilocybin treatment should it be FDA-approved.
Filament Health: botanical psilocybin for opioid-use disorder
Over in British Columbia, Canada, Filament Health Corp (NEO:FH, OTCQB:FLHLF) is advancing botanical psilocybin as a potential treatment for substance use disorders, including opioid use disorder.
A Phase 2 trial of Filament Health’s botanical psilocybin PEX010 for opioid use disorder is being conducted by researchers at the University of British Columbia.
Patients enrolled in the open-label trial are currently not undergoing any other substation therapy for opioid use.
The trial is expected to take six to eight months to complete with results expected in mid- to late-2024.
Cybin: deuterated psilocybin for major depressive disorder
Cybin Inc. (NYSE-A:CYBN, NEO:CYBN), like Compass, is investigating psilocybin for depression, specifically its proprietary deuterated psilocybin analog CYB003 as an adjunctive therapy in patients with moderate to severe major depressive disorder (MDD).
The Toronto-based biopharmaceutical firm expects to commence a multi-site Phase 3 study in early 2024 after having an end-of-Phase 2 meeting with the FDA to inform the late-stage trial.
Recruitment for the trial is expected to begin at around the end of the first quarter.
During the Phase 2 trial, CYB003 was shown to reduce depressive symptoms are a single dose and had a 79% remission rate from depressive symptoms at six after two doses (12mg).
GH Research: inhalable mebufotenin (5-MeO-DMT) for treatment-resistant depression
Dublin, Ireland-based GH Research is another psychedelic drug developer targeting MDD, including treatment-resistant forms of MDD with its proprietary inhalable mebufotenin (5-MeO-DMT) product candidate GH001.
GH001 is currently being examined in a multi-center, double-blind Phase 2b trial for patients with TRD.
In the Phase 2 part of an earlier Phase 1/2 trial, a single-day dosing regimen involving GH001 brought 87.5% of patients with TRD into ultra-rapid remission.
The double-blind phase of the Phase 2b trial is expected to be completed in the third quarter of 2024 with topline data expected in the third or fourth quarter.
Awakn Life Sciences: ketamine-assisted therapy for severe alcohol-use disorder
Awakn Life Sciences Corp (NEO:AWKN) is preparing to kick off patient enrollment for its Phase 3 trial evaluating its combination therapy of racemic ketamine delivered intravenously plus psycho-social support to treat severe alcohol use disorder.
The late-stage trial builds on an earlier Phase 2a/b trial of ketamine-assisted therapy for severe alcohol use disorder which saw patients achieve an abstinence rate of 86% six months after the treatment compared to 2% pre-trial and 25% with the current standard of care.
Enrollment in the Phase 3 trial is expected to begin in the first quarter of 2024.
Awakn expects a data readout from the trial in the second half of 2026 with a UK marketing authorization application to follow in 2027.