- $140.123M Market Capitalization
Numinus Wellness Inc. (NUMI.T) announced today that it has formally submitted its clinical trial application (CTA) to Health Canada for its Phase 1 study, HOPE, on a naturally derived psilocybe extract formulation, NBIO-01, and the Company’s patent-pending production process.
This represents a significant milestone for Numinus, reaffirming the Company’s work on developing safe and effective psychedelic products out of its Health Canada-licensed facility, Numinus Bioscience, the Company’s subsidiary.
“This application significantly advances our product development pipeline, which is aimed at broadening access to safe and effective products for psychedelic-assisted therapies. 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,” says Sharan Sidhu, Science Officer and General Manager, Numinus Bioscience.
Looks like Filament Health (FH.NE) isn’t the only psychedelic-centric company to file a CTA to Health Canada today. For context, a clinical trial application (CTA) is a submission to the competent National Regulatory Authority, in this case, Health Canada, for obtaining authorization to conduct a clinical trial. Who would have guessed?
The purpose of a CTA is to provide all of the important details related to a clinical trial to health authorities in order to obtain product approval. The application first undergoes a screening phase to ensure that all submission components have been provided. Once a thorough review is completed, applicants will either receive a No Objection Letter or a Not Satisfactory Notice, depending on if their application has been accepted or rejected, respectively.
Numinus’ HOPE Trial
The HOPE trial represents Numinus’ first fully-autonomous clinical trial. The two-phase study will take place at Numinus’ clinic in Vancouver and, upon approval, the Company will begin testing NBIO-01 for bioavailability and tolerability on 20 healthy volunteers. Subsequently, Numinus will test NBIO-01 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…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,” says Payton Nyquvest, Founder & CEO, Numinus.
NBIO-01 is Numinus Bioscience’s first proprietary formulation developed from extracts generated using patent-pending technology. The Company first submitted its provisional patent application with the United States Patent and Trademark Office (USPTO) on June 24, 2021, for a process that dramatically increases the production of therapeutics for use in psychedelic-assisted therapy.
As defined by Numinus, this process is reproducible, sustainable, and easily scalable. With this in mind, this process will be used to rapidly generate therapeutic products from psychoactive fungi species. The resulting products are intended to help treat mental health disorders that affect millions of people around the world, including depression, anxiety, trauma, pain, and substance abuse.
Numinus initially tested the production process to rapidly generate a psilocybe species extract as proof of concept. Results revealed that, in addition to being highly efficient, this process could also be applied to other species of psychoactive fungi.
Ultimately, NBIO-01 has been developed to stably deliver psilocybin and other synergistic compounds. Through the Company’s HOPE clinical trial, NBOI-01 will be studied for safety and bioavailability. Aside from Numinus’ NBIO-01, it may be worth keeping an eye on the patent status of the Company’s aforementioned processing technology.
It is worth noting that the Psychedelics Drug Market is projected to reach USD$10.75 billion by 2027, expanding at a compound annual growth rate (CAGR) of 12.36% during the forecast period. This market is expected to grow relative to a growing acceptance of psychedelic drugs for treating mental disorders. Looking forward, Numinus announced on January 7, 2022, that it rescheduled its Q1 2022 financial results for January 20, 2022.
Numinus’ share price opened at $0.73, up from a previous close of $0.70. The Company’s shares are down -1.43% and were trading at $0.69 as of 1:17 PM EST.
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