Clinical studies continue to support the use of psilocybin for mental health. For example, a study from JAMA Psychiatry found that psilocybin “worked better than the usual antidepressant medications,” as noted by NPR. New York University. found “Psilocybin produced immediate, substantial, and sustained improvements in anxiety and depression and led to decreased in cancer-related demoralization and hopelessness, improved spiritual well-being.” In addition, The Beckley Foundation said, “Psilocybin was well-tolerated and induced rapid and lasting reduction in the severity of depressive symptoms.” Helping, the US FDA says psilocybin is a “breakthrough therapy” for clinical depression. With more studies likely, it’s creating momentum for companies such as Numinus Wellness Inc. (TSXV:NUMI)(OTC:LKYSF), Cybin Inc. (NEO:CYBN)(OTC:CLXPF), Mind Medicine Inc. (NEO:MMED)(OTC:MMEDF), Compass Pathways (NASDAQ:CMPS), and Tryp Therapeutics Inc. (CSE:TRYP).
Numinus Wellness Inc. (TSXV:NUMI)(OTC:LKYSF) BREAKING NEWS: Numinus Wellness Inc.,
a company creating an ecosystem of health solutions centered around developing and supporting the safe, evidence-based, accessible use of psychedelic-assisted psychotherapies (PAP), is excited to announce it has acquired theOrbitrap Exploris 120 mass spectrometer with Vanquish Flex Binary instrument for its continued research and development of Psilocybe mushroom related projects at Numinus Bioscience, the Company's 7,000 square foot analytics and research laboratory.
Implementation of the Orbitrap, a state-of-the-art high resolution mass spectrometry instrument, will continue the accelerated trajectory of Numinus Bioscience’s research strategy to optimize cultivation, harvest, and extraction of Psilocybe mushrooms. This follows Numinus’ successful completion of the first legal extraction in Canada by a public company for research and development purposes in December.
“Numinus continues to break ground in the research and development of psychedelic-assisted psychotherapies, and the implementation of the Orbitrap Exploris 120 mass spectrometer with Vanquish Flex Binary cements our role as the centre of excellence for psychedelic research and development,” said Sharan Sidhu, Science Officer and General Manager, Numinus. “As an early psychedelic substances license holder, this announcement demonstrates our commitment to staying at the forefront of psychedelic initiatives. Acquiring the Orbitrap is a fundamental step forward in developing Numinus Bioscience’s first patent, significantly advancing Psilocybe Mushroom related psychedelic discovery research and accelerating our third-party psychedelic standardized testing capabilities.”
Numinus Bioscience is focused on developing analytical methods and formulations for the evolving psychedelics space by establishing itself at the forefront of analytical testing for psychedelics. Use of the Orbitrap Exploris 120 will allow Numinus to accelerate psychedelic standardized testing, research and development activities for third-party clients and strategic partners, as well as high throughput testing for amenable compounds.
As well, the Orbitrap will be instrumental in ensuring that dried Psilocybe Mushrooms provided for special access are safe and that the therapeutic compounds consistently meet all required specifications. This follows Health Canada’s groundbreaking announcement of its intention to revise the Special Access Programme (SAP) to permit access to MDMA and psilocybin-assisted psychotherapy in the same way other investigational medications are accessed in Canada.
Health Canada’s Notice of Intent regarding the SAP will be open for public consultation and comments for the next 60 days, and Numinus strongly encourages the community to weigh in on the benefits of the revision. View the notice here:http://www.gazette.gc.ca/rp-pr/p1/2020/2020-12-12/html/notice-avis-eng.html#nb2.
To share comments and thoughts related to the SAP, please email [email protected]a.
Other related developments from around the markets include:
Cybin Inc. (NEO:CYBN)(OTC:CLXPF), a life sciences company focused on psychedelic therapeutics, is pleased to announce that Adelia Therapeutics Inc., a wholly-controlled subsidiary of Cybin, has achieved the earn-out milestones for the period commencing November 15, 2020, as contemplated by the terms of a contribution agreement dated December 4, 2020 among Cybin, Cybin Corp., Cybin US Holdings Inc., a wholly-controlled subsidiary of Cybin, and all of the previous shareholders of Adelia. The achievement includes the successful synthesis of multiple tryptamine derivatives in sufficient quantities to initiate in vitro “Proof of Principle”; establish a ADME/PK has been completed; and to demonstrate “In Vitro” ADME “Proof of Principle” that specific synthesis modifies the metabolism of a psychedelic tryptamine.
Mind Medicine Inc. (NEO:MMED)(OTC:MMEDF), a leading psychedelic medicine biotech company announced an innovative randomized placebo-controlled study evaluating the effects of daytime and evening administration of low doses of LSD on cognitive performance, sleep quality, mood, neuroplasticity markers, emotion regulation, quality of life, and immune system response. The study will provide an additional research pathway for MindMed’s psychedelic Microdosing Division and will immediately integrate with MindMed’s plans in digital therapeutics through its newly formed Albert unit for digital medicine. The new study will be conducted in collaboration with Dr. Kim Kuypers of Maastricht University in the Netherlands, a global, leading authority on the microdosing of psychedelics.
Compass Pathways (NASDAQ:CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, is establishing its first Centre of Excellence in collaboration with The Sheppard Pratt Institute for Advanced Diagnostics and Therapeutics in Baltimore, Maryland, United States. The Centre of Excellence will model the “clinic of the future”, showcasing the best thinking in science, therapy, technology, and design. Working as a research facility and innovation lab, it will generate evidence to shape therapy models in mental health care, train and certify therapists, conduct clinical trials including proof-of-concept studies, and prototype digital solutions to improve patient experience. The first wave of research will focus on COMPASS’s investigational COMP360 psilocybin therapy, which comprises administration of COMP360 psilocybin with psychological support from specially trained therapists.
Tryp Therapeutics Inc. (CSE:TRYP) a clinical-stage pharmaceutical company developing therapeutics targeting diseases with high unmet medical needs, announced it has entered into an agreement with Albany Molecular Research Inc., a leading global contract research, development and manufacturing organization, to provide research, development and cGMP manufacturing of a proprietary psilocybin active pharmaceutical ingredient to support the clinical development of TRP-8802, TRP-8803 and TRP-8804 programs. “Working with AMRI as our U.S.-based active pharmaceutical ingredient supplier is a critical component of our rapid clinical development strategy and we very pleased to have engaged them to support our neuropsychiatric programs. By working with AMRI, we are able to create additional intellectual property around the manufacture and use of our proprietary psilocybin API.” said Larry Norder, Vice President of Manufacturing of Tryp. Mr. Norder further commented, “AMRI’s excellent industry reputation, size, and wealth of experience with manufacturing API under cGMP brings very high credibility to our efforts to develop psilocybin as a therapeutic for indications with high unmet medical needs.”
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