Las Vegas, NV, October 6, 2022 — McapMediaWire — Odyssey Health, Inc. (OTC: ODYY), f/k/a Odyssey Group International, Inc., a company focused on developing unique, life-enhancing medical products, today presents a recap of their concussion drug development program. Concussions represent an ‘unmet’ medical need and affect millions worldwide. Repetitive concussions can increase the risk of developing Chronic Traumatic Encephalopathy (CTE) and other neuropsychiatric disorders.
Odyssey acquired the intellectual property and all rights to the drug on March 1, 2021. Since the acquisition Odyssey has made significant progress in the development program. Some key success points are:
- Successful completion of the pre-clinical toxicology program.
- Successfully completed IND enabling safety studies for a Phase I human trial.
- Created a Scientific Advisory Board of renowned medical doctors who evaluated our drug technology, pre-clinical studies and are overseeing the clinical trials.
- Successful development of a nanoparticle drug formulation.
- Successful development of a spray-dried formulation for intranasal delivery with our partner Upperton Ltd based in the UK.
- Successful development and GMP manufacture of a novel breath-propelled intranasal delivery device with our partner, Design Catapult, Inc.
- The novel breath-propelled intranasal delivery device proved successful in the Phase I trial.
- Filed a patent application on the unique breath-propelled intranasal delivery device.
- Contracted with world-class contract research organizations, Avance Clinical Pty, Ltd. and Nucleus Networks to conduct the Phase I human trial.
- Obtained Alfred Ethics Board approval of an Investigators Brochure to conduct the clinical trial.
- Successful submission of clinical trial protocols to clinicaltrials.gov.
- Ongoing drug stability of the drug in the intranasal device without degradation.
- Successfully completed the Phase I human clinical trial proving the drug is safe and well tolerated.
- Created a Military Advisory Board with distinguished military veterans to assist us in selecting military sites for Phase II clinical trial.
Odyssey is currently communicating with the FDA to present the findings from the Phase I trial. Phase II trial sites are being identified and study design is being created with the site’s medical leadership and the Odyssey Medical Advisors.
According to Grandview Research, the global market for concussion treatment was valued at $6.9 billion in 2020 and is forecasted to reach $8.9 billion by 2027. Common settings for concussion include contact sports, military training and operations, motor vehicle accidents, children at play and elderly assistive-living facilities due to falls.
About Odyssey Health Inc. (formerly Odyssey Group International, Inc.)
Odyssey Health Inc. (OTC: ODYY) is a medical company with a focus in the area of life-saving medical solutions. Odyssey’s corporate mission is to create, acquire and develop distinct assets, intellectual property, and exceptional technologies that provide meaningful medical solutions. The company is focused on areas that have an identified technological advantage, provide superior clinical utility, and have a substantial market opportunity. For more information, visit the company’s website at www.odysseyhealthinc.com
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About Our Drug Candidate
PRV-002 is a fully synthetic non-naturally occurring neurosteroid being developed for the treatment of mTBI (concussion). In preclinical studies, PRV-002 has demonstrated equivalent, if not superior, neuroprotective effects compared to related neurosteroids. Animal models of concussion demonstrated that PRV-002 reduces the behavioral pathology associated with brain injury symptoms such as memory impairment, anxiety, and motor/sensory performance. Additionally, PRV-002 is lipophilic and can easily cross the blood-brain barrier to rapidly eliminate swelling, oxidative stress and inflammation in the brain while restoring proper blood flow.
About Our Drug-Device Combination
The drug formulation is designed to be administered into the upper chamber of the nasal cavity immediately after the diagnosis of concussion, using the company’s proprietary intranasal delivery device for periaxonal flow to the brain along the olfactory nerve. This route of administration, coupled with the drug’s lipophilic characteristics, enables PRV-002 to cross the blood-brain barrier within minutes and spread throughout the brain quickly, and is intended to reverse the harmful effects of a concussion.
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 continue to raise needed funds, successfully complete the Phase I trial, 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.