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Finalized study design and protocol mark major milestone to investigate natural Psilocybin
Numinus Wellness Inc. ("Numinus" or the "Company") (TSXV: NUMI), 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 Psilocybin 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, PSYBINA ™ 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 RX TM 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 RX ™ 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 RX ™ to be stable and more bioavailable, which, coupled with 75% more efficient production of PSYBINA ™ 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."
About Numinus
Numinus Wellness (TSXV: NUMI) helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model - including psychedelic production, research and clinic care - is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.
Learn more at www.numinuswellness.com and follow us on LinkedIn , Facebook , Twitter , and Instagram .
Forward-looking statements
This press release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs regarding future performance are "forward-looking statements". Forward-looking statements can be identified by the use of words such as "expects", "does not expect", "is expected", , "intends", "anticipates", "does not anticipate", "believes" or variations of these words, expressions or statements, that certain actions, events or results "may", "could", "would", "might" or "will be" taken, will occur or will be realized. Such forward-looking statements involve risks, uncertainties and other known and unknown factors that could cause actual results, events or developments to differ materially from the results, events or developments expected and expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, dependence on obtaining and maintaining regulatory approvals, including the acquisition and renewal of federal, provincial, municipal, local or other licenses, and any inability to obtain all necessary government authorizations, licenses and permits to operate and expand the Company's facilities; regulatory or policy changes such as changes in applicable laws and regulations, including federal and provincial legalization, due to fluctuations in public opinion, industry perception of integrative mental health, including the use of psychedelic-assisted therapy, delays or inefficiencies or any other reason; any other factor or development likely to hamper the growth of the market; the Company's limited operating and profitability track record; dependence on management; the Company's need for additional financing and the effects of financial market conditions and other factors on the availability of capital; competition, including that of more established and better funded competitors; the continued impact of the COVID-19 pandemic; and the need to build and maintain alliances and partnerships, including with research and development companies, customers and suppliers. These factors should be carefully considered, and readers are cautioned not to place undue reliance on forward-looking statements. Despite the Company's efforts to identify the main risk factors that could cause actual measures, events or results to differ materially from those described in forward-looking statements, other risk factors may cause measures, events or developments to materially differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company does not undertake to revise forward-looking statements, even if new information becomes available as a result of future events, new facts or any other reason, except as required by applicable laws.
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SOURCE Numinus Wellness Inc.
