Psychedelic Business News Spotlight: March 26, 2021

This week in psychedelic business news: pharmaceutical and psychedelic companies join forces, companies increase access to substances for distribution, and research goes big.

Global Inc., doing business as Mycotopia Therapies, has formed PsyBioMed-Australia, a joint venture with Melbourne, Victoria-based psychedelic research and development company Natural MedTech, to conduct clinical trials in Australia using psychedelic medicine to treat mental illness. 

The new company is expected to build and develop an R&D laboratory and a manufacturing facility in Victoria using technology by Ehave Inc., to capture and analyze data. Ehave is provider of digital therapeutics for the psychedelics and mental health sectors. 

PsyBioMed-Australia will seek licenses and permits to legally possess, supply, sell, and manufacture Schedule 8 and 9 Drugs (Schedule 9 is equivalent to America’s Schedule 1) in order to produce psychedelics in Australia under current Good Manufacturing Practices. 

The announcement comes as the Australian government, through the Medical Research Future Fund, has set aside $15 million to fund clinical research to investigate the efficacy of psychedelic-assisted therapies for various mental health conditions. 

Vancouver-based bioscience company XPhyto Therapeutics Corp., with a range of R&D projects in both Canada and Germany, is jumping into the race to pioneer new blockbuster psychedelic medicines with the launch of XPhyto Laboratories. The new division will concentrate on developing new psychedelic compounds from psilocybin derived from psychoactive mushrooms and mescaline derived from peyote and other cactus species, into mood-improving therapeutic pharmaceutical drugs. 

The company will be relying on its expertise in sublingual and transdermal therapies to deliver precise dosing of these therapies in much the same fashion as other dose-specific medications like fentanyl. 

Creso Pharma Ltd.’s soon-to-be subsidiary Canadian psychedelic medicine company Halucenex Life Scienceshas secured additional pharmaceutical-grade psilocybin to use in its upcoming clinical trial program. 

With growing interest in synthetic psychedelics, more R&D companies are entering the market, raising concerns about supply. Halucenex’s acquisition of 700 additional milligrams of psilocybin enables the company to increase the number of trial participants in Phase II trials as well as ensures participants in Phase II and III trials are treated with the same batch of synthetic psilocybin for tracking and traceability. Halucenex is one of only 11 companies in Canada to secure supplies of pharmaceutica- grade psilocybin. 

“We are very excited to progress the upcoming clinical trial program and are confident that the initiative will add to the growing body of evidence for the use of psychedelic medicines as a much-needed alternative.” Halucenex founder and CEO Bill Fleming said: “This additional batch of synthetic psilocybin reduces risks to our clinical trial schedule.”

Psychedelic life sciences company Novamind has been tapped to work with pharmaceutical giant Merck & Co., on a clinical trial investigating Merck’s experimental compound as an add-on to stable antidepressant therapy in patients with treatment-resistant depression. 

Up to 140 participants will be recruited to assess the safety and efficacy of Merck’s MK-1942 compared to a placebo group on stable antidepressant therapy. Novamind subsidiary Cedar Clinical Research will act as a key research site for the phase II study. It is unclear at this point whether MK-1942 will deliver any psychedelic effects. 

“We’re proud to partner with Merck and support its innovative neuroscience work to develop a potential new drug for treatment-resistant depression,” said Dr Reid Robison, chief medical officer of Novamind and principal investigator at CCR. “CCR has unique expertise conducting clinical trials and research studies in neuropsychiatry, for a variety of sponsors. This exciting research opportunity with Merck exemplifies a growing pipeline of opportunities for us to provide contract research services to leading drug developers.”

Ehave Inc., digital therapeutics company for the psychedelic and mental health sectors, and psychedelic company Silo Wellness Inc., announced plans to collaborate on a clinical study to better understand the “neurobiological underpinnings of immersive states of consciousness.” The goal of the story is to help researchers identify better treatment options for a variety of conditions including chronic pain, depression, bipolar disorder, general anxiety, ADHD, and schizophrenia. Ehave’s proprietary dashboard will be used to collect and sort data from the brain mapping study. 

The study will use EEG devices to measure brain activity data of participants at Silo Wellness’ Jamaican psilocybin-facilitated wellness retreats. The brain activity will be recorded beginning 15-30 minutes prior to and following the administration of psilocybin and/or its derivatives.

“Silo Wellness is delighted to collaborate on discovering innovative methods to assist in delivering the most optimal experience of wellness retreat participants through the screening of psychoactivity, which may enable us to learn even more about therapeutic dosing of psilocybin products,” said Douglas K. Gordon, Chief Executive Officer of Silo Wellness. “Scientific approaches such as this align with our ongoing commitment to leverage technology, applications and formats, such as our patent-pending psilocybin nasal spray, to both destigmatize and transform the psychedelics landscape.”