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Psychedelics Briefs: Numinus, Pacific Neuroscience Institute, Delix
Numinus Wellness announced that it has formally submitted a clinical trial application to Health Canada for a Phase I study on a naturally derived Psilocybe extract formulation, NBIO-01. It is the company’s first proprietary formulation developed from extracts generated using patent-pending technology.
“The trial will assess safety and bioavailability and be a stepping stone to the next stage for our IP development,” Sharan Sidhu, Numinus Bioscience science officer and general manager, said in a news release. “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.”
The two-phase study, known as HOPE, will take place at a Numinus clinic in Vancouver, British Columbia, Canada. Upon approval, testing will begin on 20 healthy volunteers, followed by testing against a psilocybin comparator on 28 additional healthy volunteers.
Pacific Neuroscience Institute Enrolling Participants for Psilocybin Trial
Pacific Neuroscience Institute, located at Providence Saint John’s Health Center in Santa Monica, California, has launched a psilocybin clinical trial and is now enrolling participants. Sponsored by Usona Institute, the PSIL201 study is investigating the safety and efficacy of a one-time dose of psilocybin to treat major depressive disorder.
The Phase 2 multi-site study will include 100 otherwise health participants with major depressive disorder. The participants will be divided into 2 groups: those given a single dose of psilocybin and those who receive a placebo. The primary outcome measurement will be change in a standardized depression rating scale 43 days after receiving the psilocybin or placebo.
“Given the huge demand for more effective and durable depression therapies, we are thrilled to be joining Usona Institute for this ongoing trial and are hopeful the final results will justify a larger Phase 3 Efficacy trial,” Daniel Kelly, MD, PNI director and founder, and site co-investigator of the study, said in a news release.
Delix Announces New Funding
Delix Therapeutics announced it has closed over $30 million in a convertible note financing. Funding was primarily led by existing investors, but also included “select new long-term partners,” the company said in a release. Delix has also secured a $10 million strategic credit facility in partnership with Comerica Bank’s Technology & Life Sciences practice, which will be used to enhance Delix’s ability to grow its drug development program, pipeline, and platform of novel neuroplasticity-promoting therapeutics to treat mental health disorders. The company will also look to expand its staff.
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