Odyssey Group International Announces Successful Toxicology Studies for its Concussion Drug

Rhea-AI Summary

Odyssey Group International (OTCQB: ODYY) announced a significant milestone in developing its concussion drug, PRV-002. The completion of FDA-required toxicology studies has set the stage for a Phase 1 clinical trial, contracted with Nucleus Network in Australia. Preclinical studies suggest PRV-002 has a safety margin over 100-fold the intended dosing, preparing the company for clinical trials this summer. The data will support their Investigational New Drug Application (IND) with the FDA, paving the way for future Phase 2 trials in the US.

Positive

• Completion of FDA-required toxicology studies supports the progression to clinical trials.
• PRV-002 shows a safety margin over 100-fold the intended dosing.
• Contract with Nucleus Network enhances credibility and operational efficiency for Phase 1 trials.
• Data collected in Australia will strengthen the IND application with the FDA.

Negative

• None.

Enters Agreement with Contract Research Organization for Phase 1 Trial

IRVINE, CA, May 26, 2021 (GLOBE NEWSWIRE) -- Odyssey Group International, Inc. (OTCQB:ODYY) (the "Company" or "Odyssey"), a technology and asset acquisition company focused on developing unique, life-saving medical products, today announced the completion of the Food and Drug Administration (FDA) required toxicology studies designed to support clinical trials with PRV-002, its lead drug candidate to treat concussion (mild traumatic brain injury). Odyssey has also contracted with a Contract Research Organization (CRO) for its planned Phase 1 human trial.

PRV-002 was tested in two species of laboratory animals, dosed three times per day at three escalating doses by intranasal administration for 14 days. Standard safety assessments included laboratory blood tests, urinalysis, EKG, clinical observations and detailed microscopic evaluation of all major organs. These preclinical studies demonstrated that the safety margin of PRV-002 was over 100-fold that of intended safety and efficacious dosing in clinical trials. This key data positions Odyssey to initiate human clinical testing this summer.

Odyssey’s Phase 1 clinical trials will be performed in Australia with the assistance of Nucleus Network. Inc., a leading CRO. Phase 1 clinical trial data collected in Australia is accepted by the FDA and provides Odyssey a 43% rebate on trial costs from the Australian government. These data will strengthen the Company’s Investigational New Drug Application (IND) with the FDA prior to starting Phase 2 trials back in the US. Additional preclinical studies required by the FDA have either been completed, are currently ongoing or will be completed prior to the IND submission to the FDA for phase 2.

“This is an important step in the development of our concussion drug and prepares us for clinical trials,” commented Michael Redmond, President and Chief Executive Officer of Odyssey Group International. “The toxicology results suggest tremendous safety related to our drug and we are excited to partner with an esteemed CRO such as Nucleus Network to move forward with the Phase 1 trials.”

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.

For more information, visit: http://www.odysseygi.com

About PRV-002
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.

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.

FAQ

What is the significance of the FDA-required toxicology studies for ODYY?

The completion of FDA-required toxicology studies is crucial as it allows ODYY to advance to Phase 1 clinical trials for PRV-002, its lead drug candidate.

When will the Phase 1 clinical trials for PRV-002 begin?

The Phase 1 clinical trials for PRV-002 are planned to commence this summer.

Who is conducting the Phase 1 trials for ODYY?

The Phase 1 trials will be conducted by Nucleus Network, a leading Contract Research Organization in Australia.

What financial benefits does ODYY receive from conducting trials in Australia?

ODYY benefits from a 43% rebate on trial costs from the Australian government due to the acceptance of trial data by the FDA.

How does PRV-002 compare to other treatments for concussions?

PRV-002 has demonstrated superior neuroprotective effects in preclinical studies compared to related neurosteroids, indicating its potential effectiveness in treating concussions.