Numinus Submits Clinical Trial Application for Phase 1 Trial on Proprietary Psilocybin Product

The trial evaluates Numinus' first trademarked product and patent-pending production process

 Numinus Wellness Inc. ("Numinus") (TSX: NUMI), a leader in psychedelics-focused mental healthcare, is pleased to announce that it has formally submitted the clinical trial application ("CTA") to Health Canada for its Phase 1 study, HOPE, on a naturally derived Psilocybe extract formulation, NBIO-01. This milestone further progresses and solidifies Numinus' long-standing work on developing safe and effective psychedelic products out of its Health Canada-licensed research facility, Numinus Bioscience.

"This application significantly advances our product development pipeline, which is aimed at broadening access to safe and effective products for psychedelic-assisted therapies," says Sharan Sidhu , Science Officer and General Manager, Numinus Bioscience. "The trial will assess safety and bioavailability and be a stepping stone to the next stage for our IP development. This natural product has been developed to be shelf stable, minimally variable and consistently meet label claims. The trial will not only assess safety but also give us data on comparative bioavailability."

NBIO-01 is Numinus Bioscience's first proprietary formulation developed from extracts generated using patent-pending technology, for which a patent was earlier submitted to the US Patent and Trade Office and announced on June 24, 2021 . The formulation has been developed to stably deliver psilocybin and other synergistic compounds and will be studied for safety and bioavailability.

As Numinus' first fully autonomous clinical trial, HOPE is a two-phase study that will take place at a Numinus clinic in Vancouver . Upon approval, Numinus will begin testing the extract for bioavailability and tolerability on 20 healthy volunteers, followed by testing against a psilocybin comparator on a further 28 healthy volunteers.

"At Numinus, we are focused on developing products and services in-house to ensure that high-quality standards are maintained," says Payton Nyquvest , Founder & CEO, Numinus. "I am very proud of the Numinus team – from our Bioscience experts who developed the product, to our clinical research team who will administer the study. We look forward to achieving more milestones in our mission to make psychedelic-assisted therapies accessible to all who wish to safely use them."

About Numinus
Numinus Wellness (TSX: NUMI) helps people to heal and be well through the development and delivery of innovative mental healthcare 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.numinus.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.

View original content: https://www.newswire.ca/en/releases/archive/January2022/14/c3596.html