The Phase 1 trial will enroll 14 human volunteers and assess the safety and psychoactive properties of a Psilocybe mushroom product extracted and formulated at the Numinus Bioscience lab in British Columbia, Canada . Successful completion of the landmark trial would result in safety and efficacy data for a natural Psilocybin product which could subsequently be used for further research and government-approved special access or compassionate access programs.
In addition, the trial would support Canada’s leadership in the safe production of a key psychedelic that has shown promise in treating mental health conditions including depression, end of life anxiety and substance use disorders, when used in conjunction with a standardized psychotherapy program under clinical supervision.
“This Phase 1 trial supports our mandate to improve access to safe, evidence-based psychedelic-assisted therapies in Canada and around the world,” said Payton Nyquvest , CEO, Numinus. “Through this trial, we expect to demonstrate that Numinus is well ahead in the development of natural Psilocybin therapeutics that are safe for humans and can be used to support our sector’s growth through sales to other research organizations, the creation of new intellectual property, and the ability to conduct our own Phase 2 and Phase 3 clinical trials, if we choose to do so.”
“We’re thrilled to help lead ground-breaking clinical work using Psilocybin,” said Najla Guthrie , President & CEO, KGK Science. “Our team’s expertise in the area of natural health products makes us uniquely positioned to contribute to the burgeoning psychedelics industry.”
Numinus is less than three years old, but already has a history of innovation in psychedelics. Numinus completed the first legal extraction of Psilocybe mushrooms in Canada by a public company for research and development purposes, and completed the cultivation and harvest of the first legal flush of Psilocybe mushrooms.
“We believe there are several likely advantages to naturally occurring Psilocybin therapeutics that will make them attractive for researchers and consumers alike,” said Sharan Sidhu , Science Officer and General Manager at Numinus Bioscience. “We are confident that this trial will document that natural Psilocybin extractions meet health regulator requirements for safety, efficacy and quality, and ultimately enable the establishment of better access to this medicine.”
“We are excited to see Health Canada grant legal exemptions for certain patients to use Psilocybin alongside psychotherapy in situations when other treatments have failed, and to consider revisions to its Special Access Programme that could allow Canadian patients access to psychedelic medications when other drugs have been unsuccessful,” added Dr. Evan Wood , Chief Medical Officer, Numinus. “As research interest and the potential for increased compassionate access to Psilocybin grows, it is imperative that patients have access to safe, pharmaceutical-grade supply that offers consistent psychoactive properties at scale. With this trial, we are taking the first steps towards that goal.”
Currently, Numinus is also partnering with Syreon Corporation , a global contract research organization, to undertake a single-arm, open-label compassionate access trial that will assess the efficacy and safety of Psilocybin-assisted motivational enhancement therapy using a synthetic Psilocybin product. The study will contribute to a growing body of research to inform larger randomized controlled trials for these indications. The study will take place in Vancouver and will enroll 30 individuals with opioid, stimulant and/or alcohol use disorders.
Numinus Wellness (TSX-V; NUMI) empowers 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 Wellness 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 abuse. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice, and building the foundation for a healthier society.
As a global Contract Research Organization (CRO), KGK Science performs a productive and pioneering role in the realm of scientific study. For over two decades, it has offered well-designed, customized solutions to each of its clients, consolidating its scientific, clinical, commercial, and regulatory abilities into one full-service package. Equipped with state-of-the-art technologies, novel research techniques, and a seasoned team of thought leaders, KGK remains at the forefront of its industry. And, by seamlessly matching its experience with its drive for innovation, this CRO is able to respond effectively to expanding trade and consumer demands.
Forward Looking Statements
This news 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 of future performance, are “forward-looking statements.” Forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward looking statements. Such risks and uncertainties include, among others, dependence on obtaining and maintaining regulatory approvals, including acquiring and renewing federal, provincial, municipal, local or other licences and any inability to obtain all necessary governmental approvals licences and permits to operate and expand the Company’s facilities; regulatory or political change such as changes in applicable laws and regulations, including federal and provincial legalization, due to inconsistent public opinion, perception of the medical-use of psychedelics, bureaucratic delays or inefficiencies or any other reasons; any other factors or developments which may hinder market growth; the Company’s limited operating history and lack of historical profits; reliance on management; the Company’s requirements for additional financing, and the effect of capital market conditions and other factors on capital availability; competition, including from more established or better financed competitors; and the need to secure and maintain corporate alliances and partnerships, including with research and development institutions, customers and suppliers; the development and implementation of medical protocols and treatment standard operating procedures for the use of psychedelic therapies; the Company’s goals to develop and implement partnerships with research organizations and other key players in the integrative mental health industry; the Company’s ability to successfully withstand the economic impact of COVID-19; the medical benefits, safety, efficacy, dosing and social acceptance of psychedelics; the approval and/or success of compassionate access clinical trials; the cultivation and harvest of Psilocybe mushrooms; and the availability of trained personnel and medical professionals. These factors should be considered carefully, and readers are cautioned not to place undue reliance on such forward-looking statements. Although the Company has attempted to identify important risk factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other risk factors that cause actions, events or results to 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 has no obligation to update any forward-looking statement, even if new information becomes available as a result of future events, new information or for any other reason except as required by law.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
SOURCE Numinus Wellness Inc.
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