Shroom Shmooz

The clinical trial landscape in psychedelics has evolved significantly over the past five years and has seen significant developments and milestones achieved in the last year. There are currently more than 50 active clinical trials investigating the therapeutic value of psychedelic-based compounds as part of a treatment regimen, which includes the more traditional psychotherapy intervention. About 60% of these clinical investigations have advanced to Phase II and Phase III stage trials. There is also a robust backlog of Phase I candidates and pre-clinical stage studies. With the progression of three studies to the latest stage of the clinical trial process, we now appear to be closing in on an inflection point for the psychedelic medicine industry. Following outstanding Phase III results for its MDMA-assisted therapy candidate for the treatment of post-traumatic stress disorder (PTSD), MAPS is expected to submit its new drug application (NDA) for marketing approval of the treatment in the next quarter. Compass Pathways' (CMPS) psilocybin-assisted treatment for treatment-resistant depression (TRD) began its Phase III trial, while Awakn Life Science's (AWKN) ketamine-assisted therapy for severe alcohol use disorder, supported by positive Phase II results and UK government funding, is on schedule to commence its Phase III studies in the second half of 2023. We present a review of each of these drug development programs. The funding environment has become far less friendly in the past year. This threatens to stymie progress, particularly for some of the early-stage development programs underway. Positive results will be the key differentiator in attracting funds in the more hostile funding environment.