“Magic mushrooms may be the biggest advance in treating depression since Prozac,” says Newsweek. Not only has the US FDA granted “breakthrough status” to psilocybin, dozens of medical studies are seeing positive study results, including Johns Hopkins Medicine and New York University. In addition, a study from JAMA Psychiatry found that psilocybin “worked better than the usual antidepressant medications,” as noted by NPR. Even The Beckley Foundation has said, “Psilocybin was well-tolerated and induced rapid and lasting reduction in the severity of depressive symptoms.” Better. with plenty of clinical trials supporting psilocybin treatments, it’s only a matter of time before big pharmaceutical companies begin to invest heavily, and incorporate the drug into their own drug pipelines. All could be substantial catalysts for companies, such as Numinus Wellness Inc. (TSXV:NUMI)(OTC:LKYSF), Mind Medicine (NASDAQ:MNMD) (NEO:MMED), Cybin Inc. (NEO:CYBN)(NYSE:CYBN), Field Trip Health Ltd. (NASDAQ:FTRP)(TSX:FTRP), and COMPASS Pathways (NASDAQ:CMPS).
Look at Numinus Wellness Inc. (TSXV:NUMI)(OTC:LKYSF), For Example
Numinus Wellness, a leader in psychedelics-focused mental healthcare, is pleased to have finalized the study design and protocol for a Phase 1 clinical trial on a naturally derived Psylocibin extract, previously announced on April 26, 2021. This major milestone advances Numinus’ investigation of its first proprietary psychedelic product, which was developed using a patent-pending technology submitted to the US Patent and Trade Office.
Numinus Bioscience has successfully developed a natural extract, PSYBINATM from Psilocybe species using IP technology related to the production of extracts and downstream derivatives and formulations from Psychoactive Species Cultured Mycelium. The Phase I clinical trial, “A Healthy Adult Investigation Observing Endpoint Measures of Safety and Relative Bioavailability of Psilocybin in comparison to a Psilocybe extract: a fasting, blinded, crossover study” (HOPE), will ascertain the safety and bioavailability of the subsequent formulation PSYBINA RXTM developed to stably deliver Psilocybin and other synergistic compounds. The trial design compares the innovative formulation, designed to be more bioavailable, with synthetic Psilocybin as a baseline comparator and exploratory brain scans will visualize the potential differences in neuroactivity.
With its licensed capabilities, Numinus’ lab will produce, package and label both PSYBINA RXTM and the Psilocybin comparator for the clinical trial which will be conducted at Numinus’ clinical site in Vancouver, British Columbia on 14 healthy volunteers.
"This is a benchmark trial for Numinus Bioscience as it not only tests our theory of synergies of natural complex matrices but also our product design and patent-pending technology,” says Sharan Sidhu, Science Officer and General Manager at Numinus Bioscience. “Our research team has developed PSYBINA RXTM to be stable and more bioavailable, which, coupled with 75% more efficient production of PSYBINATM using our technological advancements, aims to reduce our production costs of therapeutic products, further advancing our mission of increasing accessibility in psychedelic medicine.”
“The Phase 1 launch leverages multiple Numinus assets, including our Clinical Research team and Numinus Bioscience team working together to successfully develop and run this clinical trial,” says Payton Nyquvest, Founder & CEO, Numinus. “The majority of the work from discovery, research and development, production, clinical trial application and trial conduct are all happening in house, demonstrating our leadership and capabilities in psychedelic therapeutics.”
Other related developments from around the markets include:
Mind Medicine, a leading biotech company developing psychedelic-inspired therapies, has joined the Clinical Trials Transformation Initiative (CTTI) to contribute in developing and driving adoption of practices that increase the quality and efficiency of clinical trials. MindMed joins CTTI as one of approximately 80 member organizations interested in advancing higher quality clinical trials and accelerating the path to new therapeutics and other medical products. CTTI convenes its members – along with nearly 500+ multi-stakeholder organizations and individuals from across the clinical trials ecosystem – to discuss issues, exchange ideas, and come to a consensus on solutions to the greatest challenges in clinical research. As a member of the Steering Committee, MindMed will contribute to setting project priorities within CTTI’s agenda, as well as serving on the teams that create recommendations and resources to transform clinical trials globally.
Cybin Inc., a biotechnology company focused on progressing psychedelic therapeutics, announced the completion of its 74thpre-clinical study as it continues to progress its proprietary psychedelic molecules into Investigational New Drug-enabling studies. Cybin’s Research and Development team has completed 74 in-vitro and in-vivo evaluations of Cybin’s expanding portfolio of psychedelic compounds being designed for potential therapeutic applications for several mental health conditions. To date, more than 50 novel compounds have been evaluated through collaborations with experienced contract research organizations for pharmacokinetic/pharmacodynamic profile, metabolic stability, receptor binding, and safety in order to identify preferred candidates for further development.
Field Trip Health Ltd., a global leader in the development and delivery of psychedelic therapies, announced the opening of their Seattle clinic, their sixth in the United States, along with the recent opening of a location in Fredericton, NB, and the imminent opening of a location in Vancouver, BC. As the largest provider of psychedelic-assisted therapies globally, Field Trip continues to distinguish itself as a leader in the emerging psychedelic industry with continued expansion and growing demand.
COMPASS Pathways, a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, says it has been granted its fourth patent by the US Patent and Trademark Office (USPTO). This is COMPASS’s first patent with claims covering its Form A hydrate psilocybin. The Form A hydrate is distinct from the anhydrate psilocybin for which the company has already been granted eight patents in the US, UK, Germany and Hong Kong, and which is used in COMP360, COMPASS’s synthesised psilocybin formulation being developed for psilocybin therapy in treatment-resistant depression.
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