Odyssey Health, Inc. Completes Safety Evaluation of Cohort II for Concussion Drug

Rhea-AI Summary

Odyssey Health, Inc. (OTC Pink: ODYY) announced favorable safety results from Cohort II of its Phase I clinical trial for PRV-002, a novel drug to treat concussions. Conducted at Nucleus Network, this cohort included six healthy volunteers with no severe adverse events. All vital signs and blood tests remained normal, leading to unanimous approval for the next cohort with increased dosage. CEO Michael Redmond highlighted ongoing discussions for Phase II/III trials. The global concussion treatment market is projected to grow from $6.9 billion in 2020 to $8.9 billion by 2027.

Positive

• Phase I trial shows PRV-002 is safe and well-tolerated.
• Cohort II results indicate no severe adverse events or abnormalities in vital signs.
• Unanimous approval to double the treatment dose for the next cohort.
• CEO optimistic about the future efficacy of PRV-002 and potential Phase II/III trials.

Negative

• None.

Las Vegas, NV, June 29, 2022 (GLOBE NEWSWIRE) -- Odyssey Health, Inc. (OTC Pink: ODYY), f/k/a Odyssey Group International, Inc., a company focused on developing unique, life-saving medical products, today announced positive safety findings from Cohort II of their Phase I clinical trial. Odyssey’s trial involves administering PRV-002, the Company’s novel drug to treat concussion, to healthy human subjects. Data from Cohort II indicates that the drug was safe and well-tolerated.

The trial is being conducted at Nucleus Network, a leading clinical research organization. Cohort II was unblinded and evaluated by the Safety Review Committee. Cohort II included six healthy human volunteers who received one dose of PRV-002 or placebo followed by evaluations for abnormal responses. No severe adverse events were noted, as PRV-002 was well-tolerated. Vital signs, EKG readings, sleep patterns and breathing function were all normal.  Blood labs showed no alterations associated with the PRV-002 treatment. Pharmacokinetic analysis was done by comparing these results to the animal findings of max concentration (NOEL) prior to toxicity to determine the highest concentration (Cmax) of PRV-002 and the time course (AUC) of PRV-002 concentrations in the blood to ensure that elevating the dose would be safe.

“After reviewing the data from Cohort II, I have strong confidence that PRV-002 will continue to show safety for this Phase I clinical trial as an option for the treatment of concussion. No abnormalities were seen, and we have unanimously approved the next cohort where the treatment dose will be doubled.,” commented Dallas Hack, MD, member of the Safety Review Committee.

Michael Redmond, CEO of Odyssey Health, commented, “PRV-002 continues to be well-tolerated as we increase the intranasal dose levels. We look forward to completing Phase I Clinical Trials and moving into a Phase II/III to determine the efficacy of PRV-002 for concussed patients. I believe that intranasal brain-targeting will be the key to its success. We are currently in discussions with military training sites for our Phase II/III clinical trials.”

The Phase I clinical trial is ongoing and consists of 40 healthy subjects. The trial has a single ascending dose and a multi ascending dose component to it. Odyssey will report additional results as they become available. Odyssey is currently scheduling a meeting with the FDA to present the findings from this Phase I trial.

Concussions represent an ‘unmet’ medical need and affect millions worldwide. The global market for concussion treatment was valued at $6.9 billion in 2020 and is forecasted to reach $8.9 billion by 2027, according to Grandview Research. Common settings for concussion include contact sports, military training and operations, motor vehicle accidents, and elderly assisted-living facilities due to falls.

About Odyssey Health Inc. (formerly Odyssey Group International, Inc.)
Odyssey Health, Inc. (OTC Pink: 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.

We encourage our shareholders to visit: https://odysseygi.com/ or Twitter: @OdysseyGroupIn1.

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.

About Nucleus Network

Nucleus Network is the only multi-site Phase 1 clinical trials provider located in Australia and the USA. Nucleus Network provides high-quality, first-in-human and early-phase trials for biotechnology and pharmaceutical companies across the USA, Europe and Asia. Located within cutting-edge health precincts, their cost-effective, accelerated clinical development solutions are supported by advanced technology, clinical excellence, and research expertise.

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 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.

Contact:
info@odysseygi.com
Local: 702-780-6559 
Toll-free: 844-368-9663
Fax: 725-888-4715

FAQ

What are the Phase I clinical trial results for PRV-002 by Odyssey Health?

Cohort II of the Phase I trial showed PRV-002 to be safe and well-tolerated, with no severe adverse events.

What is the market potential for concussion treatment according to Odyssey Health's press release?

The global market for concussion treatment was valued at $6.9 billion in 2020 and is expected to reach $8.9 billion by 2027.

What are the next steps for Odyssey Health regarding PRV-002?

Odyssey plans to double the treatment dose in the next cohort and is discussing Phase II/III clinical trials.

Who conducted the clinical trial for PRV-002?

The clinical trial is being conducted at Nucleus Network, a leading clinical research organization.

What was the approval outcome for the next cohort in the PRV-002 trial?

The Safety Review Committee unanimously approved the next cohort where the treatment dose will be doubled.