Las Vegas, Nevada, Nov. 23, 2022 (GLOBE NEWSWIRE) — Odyssey Health, Inc. (OTC: ODYY), f/k/a Odyssey Group International, Inc., a company focused on the development of unique, life-enhancing medical products, today released a company update and summary of its concussion development program. Concussion represents an “unmet” medical need, affecting tens of millions of people worldwide.
Odyssey acquired the intellectual property and all rights to the concussion drug in March 2021. Since the acquisition, Odyssey has added key industry experts to management, made significant progress in its drug development program, and completed a Phase I human clinical trial. Major successes include:
- Adding two key people to the management team who have relevant pharmaceutical experience to move drugs through the clinical process and to market.
- Completion of FDA-required IND studies for a Phase I human trial. This work was carried out in collaboration with several GMP/GLP external suppliers.
- Development of a spray-dried nanoparticle formulation for intranasal delivery to enhance brain uptake. This work was carried out in collaboration with our UK partner under GMP regulations.
- Development and GMP manufacturing of our new breath-driven intranasal delivery device with our California-based technical partner.
- Patent pending for our new breath-driven intranasal delivery device.
- Contracted with world-class contract research organizations, Avance Clinical Pty, Ltd. and Nucleus Networks to conduct the Phase I clinical trial.
- Outstanding compliance of our breath-driven intranasal delivery device in the Phase I study.
- Completion of the Phase I clinical trial in humans, showing that the drug is safe and well tolerated.
- Phase I human clinical trial showed no drug accumulation during the patient’s 10-day follow-up visit.
- Persistent drug stability at elevated temperatures showing no degradation
- Raised more than $5 million to support the company and its development efforts and access to an equity line with Lincoln Park Capital for up to $10 million.
About Odyssey Health Inc. (formerly Odyssey Group International, Inc.)
Odyssey Health Inc. (OTC: ODYY) is a medical company with a focus on life-saving medical solutions. Odyssey’s corporate mission is to create, acquire and develop various assets, intellectual property and exceptional technologies that provide meaningful medical solutions. The company focuses on areas that have an identified technological advantage, offer superior clinical utility and significant market opportunities. For more information, visit the company’s website at www.odysseyhealthinc.com
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About our candidate drug
Our drug candidate is a fully synthetic, non-naturally occurring neurosteroid being developed for the treatment of moderate traumatic brain injury. In preclinical studies, the drug has shown equivalent, if not superior, neuroprotective effects compared to related neurosteroids. Animal models of concussion showed that the drug reduces the behavioral pathology associated with brain injury symptoms, such as memory impairment, anxiety, and motor/sensory performance. In addition, the drug is lipophilic and has been shown in preclinical studies to readily cross the blood-brain barrier to rapidly eliminate swelling, oxidative stress and inflammation in the brain while restoring proper blood flow. Our new breath propelled intranasal brain drug delivery device is designed with a new drug delivery system that creates an effective airflow for depositing concentrated drugs deep into the nasal cavity and on the olfactory area, this should provide a quick and direct diffusion in the brain.
This press 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 on our current expectations and speak only as of the date hereof. Our actual results could differ materially and unfavorably from those expressed in forward-looking statements due to various factors and uncertainties, including our ability to continue to raise needed funds, successfully complete additional clinical trials, our ability to development, rapid changes in our markets, changes in demand for our future products, and regulatory, competitive and general economic developments.