Psychedelic Business News Spotlight: April 30, 2021

This week in psychedelic business news: Cybin’s experimental psychedelic takes aim at alcohol use disorder, Numinus seeks volunteers for its natural psilocybin extract, and another psychedelic company trades on Nasdaq. 

Toronto-based biotech company Cybin Inc., announced it will focus its proprietary deuterated psychedelic tryptamine CYB003 for the treatment of alcohol use disorder (AUD), a condition that affects approximately 14.4 million adults in the United States. The company hopes to file an investigational new drug (IND) application by the end of 2021.

“The evidence of increased alcohol use during this ongoing pandemic is startling. For so many individuals and families, alcohol use disorder can be disruptive, even devastating. We are optimistic that CYB003 could have the potential to improve the lives of AUD sufferers and their loved ones by providing a durable respite from alcohol dependence and the potential to overcome this often-crippling disease,” said Doug Drysdale, Cybin’s chief executive officer.

Mental health care company Numinus Wellness Inc, is partnering with KGK Science, a contract research organization with expertise in natural products, to conduct a Phase I clinical trial on 14 human volunteers to assess the safety and psychoactive properties of psilocybin extracted and formulated at the Numinus Bioscience lab in British Columbia, Canada. The trial results could determine whether the company’s natural psilocybin product can be used in future research. 

Numinus is also partnering with Syreon Corporation, a global contract research organization, to conduct a single-arm, open-label compassionate trial to assess the efficacy and safety of psilocybin-assisted motivational enhancement therapy using a synthetic psilocybin product. The study aims to enroll 30 participants with opioid, stimulant and/or alcohol use disorders. 

Revive Therapeutics Ltd., a life sciences company that researches and develops therapeutics for medical needs and rare disorders, has filed an application with the U.S. Food and Drug Administration (FDA) for Orphan Drug Designation (ODD) for psilocybin to treat moderate to severe traumatic brain injury (TBI).

There are currently no FDA-approved treatments for TBI-related cognitive impairment. However, the company believes that based on preclinical studies conducted at the National Health Research Institutes, psilocybin’s neuro-reparative effect may hold the potential to improve loss of cognitive function after TBI and lessen disability. The company aims to evaluate psilocybin in a clinical trial for moderate to severe TBI using its proprietary oral thin film psilocybin product.

Health Canada has granted New Leaf Canada’s subsidiary Psirenity approval to construct a psilocybin research facility in Norfolk County. The new research center will be approximately 185 square meters within the larger New Leaf facility, and will focus its research and development into the following key areas:

• Formulation of investigational products for future clinical trials
• Supply of investigational products for Psirenity’s clinical trials
• Psilocybin and psilocin production
• Psilocybin-containing mushroom strain development
• Supply of prescription-controlled drugs for Psirenity’s Health and Wellness Therapy Clinics
• Extraction and isolation of psilocybin and psilocin method development

“What we’re working on is a microdosing platform. Something that doesn’t have the psychotropic effects where you can take your microdose and be able to go about your day. You can go to work, you can drive your car, and so forth,” said Psirenity CEO Chris McCullough. 

Psilocybin remains illegal in Canada. However, Health Canada has granted compassionate use exceptions granted on a case-by-case basis. 

Psychedelic biotech company MindMed began trading on the Nasdaq this week under the symbol MNMD, becoming the second psychedelic company to go public in the United States since U.K.-based Compass Pathways last September. Share prices tumbled 29 percent on the first day of trading after experiencing increases on the OTC QB market of 65 percent Friday and 33 percent Monday leading into the up-listing. 

“These are still very early innings for us,” MindMed’s co-founder and CEO JR Rahn told Yahoo Finance Live. “We’re not going to be dictated by the day-to-day fluctuations or hour-by-hour fluctuations of our stock. We have 180,000 shareholders. A lot of them are very mission driven.”

New York-based MindMed is also trading on the Canadian NEO Exchange under the MMED symbol and in Germany’s Frankfurt Stock Exchange under the symbol MMQ.