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

Rhea-AI Summary

Odyssey Health, Inc. (OTC Pink: ODYY) announced positive safety results from Cohort I of their Phase I clinical trial for PRV-002, a novel drug aimed at treating concussions. Conducted at Nucleus Network, the trial involved eight healthy subjects who reported no severe adverse effects, indicating that PRV-002 was well-tolerated. Vital signs and lab results remained normal. With a global concussion treatment market valued at $6.9 billion in 2020, Odyssey is optimistic about the drug's potential efficacy in future trials, as stated by executives.

Positive

• PRV-002 demonstrated a good safety profile in a Phase I clinical trial with no severe adverse events reported.
• The global market for concussion treatment is projected to grow from $6.9 billion in 2020 to $8.9 billion by 2027, presenting a significant commercial opportunity.

Negative

• None.

Irvine, CA, June 01, 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 I 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. For Cohort I, the drug was safe and well tolerated. Concussions represent an ‘unmet’ medical need.

The trial is being conducted at Nucleus Network, a leading clinical research organization. Cohort I was unblinded and evaluated by the Safety Review Committee. Cohort I included eight healthy human volunteers that 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 this cohort, 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 increased. I look forward to completing the Phase I trial and assisting Odyssey in presenting these safety findings to the FDA,” commented Dallas Hack, MD, member of the Safety Review Committee.

Jacob VanLandingham, Ph.D., VP of Drug Development for Odyssey Health, commented, “PRV-002 appears to be well-tolerated when given intranasally. If PRV-002 is found to be efficacious for concussed patients in the Phase 2/3 trials, I believe that intranasal brain-targeting will be the key to its success. So far, the intranasal drug/device combination is holding up well in the clinical setting.”

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.

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 assistive-living facilities due to falls.

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

We encourage our shareholders to visit: http://www.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:
Odyssey Health, Inc. f/k/a Odyssey Group International, Inc.
info@odysseygi.com

FAQ

What are the safety findings of PRV-002 from Odyssey Health's clinical trial?

Odyssey Health's Phase I clinical trial for PRV-002 showed no severe adverse events, indicating the drug was well-tolerated by participants.

What is the significance of the Phase I clinical trial for ODYY?

The Phase I trial is crucial for ODYY as it assesses the drug's safety profile before advancing to later trial phases.

Who conducted the clinical trial for PRV-002?

The clinical trial for PRV-002 was conducted at Nucleus Network, a leading clinical research organization.

What is the market forecast for concussion treatment?

The global concussion treatment market is expected to grow from $6.9 billion in 2020 to $8.9 billion by 2027.

When were the results of the Phase I clinical trial for PRV-002 announced?

The results from Cohort I of the Phase I clinical trial for PRV-002 were announced on June 1, 2022.