Psirenity Announces Exclusive Licence Agreement for Psilocybin

TORONTO, Dec. 6, 2021 /PRNewswire/ - Psirenity Chief Executive Officer Mark Thompson today announced the completion of an exclusive licence agreement with New Leaf Canada Inc. ("New Leaf") for New Leaf's licence pursuant to the provisions of the Controlled Drugs and Substances Act and its Regulations for Psilocybin and Psilocin.

"The execution of this exclusive licence agreement is a critical next step in the development of Psirenity's mental health solutions" said Mark Thompson, Psirenity's Chief Executive Officer. "Through its relationship with New Leaf, Psirenity can begin research in Canada into the use of psilocybin for diseases of the central nervous system ("CNS") which we believe do not have adequate therapies". The terms of the licence agreement were not immediately disclosed.

Psirenity today also announced the division of its business into two separate operating units: Psirenity Health and Psirenity Discovery. 

Psirenity Health, through its virtual clinic, will provide its members seamless access and delivery of proactive healthcare solutions. This platform will provide its members with the ability to access healthcare professionals to assist them in understanding their healthcare needs and start them on their journey to wellness. The clinic will be integrated with a patient's smartphone and smartscale which will provide immediate access to healthcare and wellness data. Through the virtual clinic, a member will be able to speak with a healthcare professional, receive their personal assessment and obtain their therapeutics directly to their home.

Psirenity Health is developing proprietary product offerings and protocols that will provide members with a best-in-class proactive treatment experience. These product offerings will provide members with the fundamental therapeutics that a person needs to achieve their best quality of life.  While most medicine is reactive, Psirenity Health's protocols and proprietary therapeutics are designed to enhance health and provide a stronger physical foundation to combat disease and aging.

Psirenity Discovery will continue to explore the use of psilocybin for the treatment of CNS disorders. Psirenity Discovery intends on commencing a Phase I trial in the first quarter of 2022. This trial will include 36 participants who will receive 4mg, 8mg and 12mg of oral sustained release capsules of psilocybin as single doses over one week. Participants will be assigned to one of two dosing regimens using either the Fadiman regime or the Stamets regime. Pharmacokinetics will be assessed on day 1 and day 4 and safety measures will be completed on each visit and via telephone monitoring on day 7 and day 14. The trial will study the pharmacokinetic profile of psilocybin, the optimal tolerated dose and dose-limiting toxicity. 

Psirenity Discovery will also begin work on Psilocybin in Canada in the first quarter of 2022.  In 2021, Psirenity Discovery reviewed hundreds of potential disease candidates for which psilocybin may provide a clinical benefit. As a result of this work, Psirenity Discovery intends on commencing clinical work in cluster headache, a rare disease suffered by thousands of people worldwide.  Cluster headache is recognized by the National Association of Rare Disorders ("NARD") and is categorized as a form of primary neurovascular headache. According to the NARD, Cluster headaches are the most painful form of headaches, with the pain occurring most commonly on one side of the head and behind or above the eye or at the temple. The pain has been described as searing, burning and stabbing. The age of onset is most often between 20 and 40, and they are more common in men than women with a ratio of 2:1. Cluster headache is divided into episodic and chronic. Episodic cluster headache patients usually suffer from 1 to 4 short headaches a day that can individually last between 15-120 minutes when they are having a series of attacks. Cluster headaches affect approximately 300,000 patients in the United States.

Psirenity believes that traditional pharmaceutical treatments are in many cases ineffective and that people will benefit from a new proactive healthcare paradigm developed by Psirenity. The guiding principle of Psirenity is its desire to help people to reach their personal goals and find effective therapies that allow them to lead their best lives.

This is the Science of Peace of Mind™.

SOURCE Psirenity