Pre-clinical data for PRV-002, a nasally delivered drug in development for treating concussion, highlight rapid brain bioavailability

IRVINE, CA / ACCESSWIRE / February 17, 2021 / Odyssey Group International, Inc. (OTCQB:ODYY) ("Odyssey"), a technology and asset acquisition company focused on developing unique, life-saving medical products, and Prevacus Inc., are pleased to report the results of pre-clinical studies related to brain biodistribution of PRV-002 (Prevasol), a novel compound in development for the treatment of concussion.

In this study, PRV-002, a neurosteroid, was formulated in its native form and as a nanoparticle. Pre-clinical animal studies of PRV-002 have shown rapid absorption in the brain with biodistribution across the entire brain when administered nasally.

"We are pleased to see such a significant level of the compound reach the brain over the 8-hour period of nasal administration. These data confirm our hypothesis that the administration of nasal nanoparticles improves brain bioavailability. PRV-002 was most concentrated in the frontal lobe, which makes perfect sense given its direct connection with the olfactory nerves. Nasal application is ideal for quick, on-the-field administration and conditions of acute brain inflammation where immediate treatment is critical." said Dr. Jake VanLandingham, Chief Executive Officer of Prevacus.

In this study, conducted by Inotiv for Prevacus, both forms of PRV-002 were nasally administered to subjects three times: one initial dose and two subsequent doses given in 4-hour intervals. Brain tissue was analyzed at 8-hours post-initial nasal application. When formulated as a nanoparticle, approximately 40% more PRV-002 was found in all brain cortices, including the cerebellum, at 8-hours. These results were almost identical when measured in cerebrospinal fluid. When allometrically scaled, the dosing concentrations in this study represent the lowest dose intended for use in the planned Phase 1 human trials.

Michael Redmond, CEO of Odyssey added, "concussion is a serious health issue in sports, the military and in elderly populations which currently has no FDA approved drug treatment. These animal data support PRV-002's brain bioavailability following brain trauma. We are eager to close our transaction and contribute to the drug development program."

Odyssey previously entered into a definitive agreement with Prevacus to acquire the Active Pharmaceutical Ingredient PRV-002 (Prevasol) to treat traumatic brain injury on January 11, 2021. The definitive agreement has been signed, and the transaction is expected to close by the end of February 2021. The transaction is conditional on Prevacus shareholder approval and other customary closing conditions.

About Odyssey Group International, Inc.
Odyssey Group International, Inc. (OTCQB:ODYY) is a technology and asset acquisition company with a focus in the area of life saving medical solutions. Odyssey's corporate mission is to create, acquire and accumulate distinct assets, intellectual properties, and exceptional technologies that provide meaningful medical solutions. The Company is focused on building and acquiring assets in areas that have an identified technological advantage, provide superior clinical utility, have a substantial market opportunity and provide solid returns to its valued shareholders and partners.

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About Prevacus, Inc.
Prevacus, Inc. is a biopharmaceutical company developing drug candidates with the potential to advance treatment in the fields of traumatic brain injury and other neurological disorders. The Company's first two development candidates (PRV-002 and PreVPro) represent breakthrough strategy for treating concussion working at the molecular level to simultaneously reduce inflammation, swelling, impaired cerebral blood flow and oxidative stress.

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Forward-Looking Statements
This news release may contain forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including our ability to close on the agreement in a timely manner, successfully complete a Phase 1 clinical trial, the economic slowdown affecting companies, our ability to successfully develop products, rapid changes in our markets, changes in demand for our future products, and legislative, regulatory, competitive developments and general economic conditions.

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SOURCE: Odyssey Group International, Inc

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