Cybin Corp.: A Diversified Play on Psychedelic Therapeutics
Ryan Allway
August 26th, 2020
Exclusive, Psychedelics, Top Story
More than 700 million people around the world suffer from a mental illness, addiction or eating disorder, according to the World Health Organization, which costs the global economy $2.5 trillion each year in direct and indirect costs. Despite these significant costs, large pharmaceutical companies have stopped searching for the next Prozac.
Psychedelics, including psilocybin, MDMA and other substances, have emerged as potential therapeutics for mental illnesses following decades of prohibition. Johns Hopkins launched a psychedelics research unit, MAPS raised $30 million for a Phase III clinical trial and the FDA granted ‘breakthrough therapy’ status to several psilocybin treatments.
Cybin Corp. aims to build upon these early successes by manufacturing its own proprietary API, conducting clinical trials targeting major depressive disorder and smoking addiction while developing innovative delivery mechanisms like its oral thin film and microdosing technology.
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Developing a Proprietary API
A key bottleneck in conducting clinical trials in psychedelics is securing psilocybin. It takes academics about a year to secure a supply for their studies since they require institutional review board approval, FDA approval and DEA approval. These delays are both costly and jeopardize the inroads that psychedelics have made in providing treatment options.
In the near-term, Cybin Corp. secured a GMP source for psilocybin for its oral thin film manufacturing and its initial clinical trial targeting moderate depressive disorder. The source can ship the substance to any academic or research facility with a drug establishment license and any other necessary approvals in place.
The company also signed an agreement with Smart Medicines GMP Inc. to manufacture psilocybin for future clinical trials. The goal is to expand production into other analogues found within magic mushrooms and scale production to meet the needs of academic and corporate institutions in need of a source of synthetic psychedelic substances.
Conducting Clinical Trials
Cybin Corp. plans to conduct a series of clinical trials designed to bring approved therapeutics to market. In choosing indications, the company’s management team has focused on large markets where early research has shown tremendous promise. The goal is to become the first approved product and capture maximum market share.
The company plans to conduct a Phase 2a and Phase 2b clinical trials in patients with major depressive disorder in partnership with the University of West Indies. By following strict ICH and GCP guidelines, the study will allow the use of data collected to enter other jurisdictions, including the United States, Canada and Europe.
In addition, the company is planning a Phase 2 clinical trial in patients with smoking addiction. Early research has shown that psilocybin could decrease smoking by 80% within six months, which exceeds rates for other behavioral or pharmacological therapies. The clinical trial will be conducted in the United States and Canada.
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Developing Delivery Mechanisms
Cybin Corp. has developed two delivery mechanisms that could transform psychedelic therapies by reducing the side effects of psilocybin and making it easier to deliver the benefits. By developing these in conjunction with running clinical trials, the company is taking a holistic approach to the market that could provide a competitive edge over the coming years.
The company’s oral thin film technology is designed to increase bioavailability and flexibility at a significantly lower cost than pill-based therapeutics. Patients can administer the therapy without water at any time during the day while direct access to the carotid artery provides a more effective delivery than going through the stomach and liver.
In addition to oral thin film, the company is testing microdosing technology that would provide roughly one-tenth of the ‘trip’ dose of a psychedelic drug to avoid triggering hallucinations but still provide cognitive benefits. Management is working with the Canadian Centre for Psychedelic Sciences to determine the safety and efficacy of microdosing techniques.
Looking Ahead
Cybin Corp. is one of the most diversified and expansive companies in the nascent psychedelics industry. With a focus on everything from API procurement to delivery mechanisms, the company provides exposure to nearly every corner of the therapeutic market. The company is also working on over-the-counter therapeutics using functional mushroom ingredients.
With plans to list on the Canadian Securities Exchange (CSE), investors may want to follow the company’s efforts over the coming months. Accredited investors interested in participating in earlier rounds of financing may also have opportunities ahead.
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About Ryan Allway
Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.
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