Odyssey Health, Inc. Announces Positive Results from Its Phase I Multi-Day Ascending Dosing for the Treatment of Concussion

Rhea-AI Summary

Odyssey Health (OTC: ODYY) announced positive safety results from Cohort I of its Phase I clinical trial for PRV-002, a drug addressing concussion treatment. Administered to eight healthy volunteers over five consecutive days, PRV-002 was found to be safe and well tolerated, with no severe adverse events reported. Conducted by Avance Clinical Pty Ltd, the trial aims to evaluate PRV-002's efficacy as a potential solution to a significant medical need in concussion management. The ongoing Phase I trial will include a total of 16 healthy subjects, with additional results to be reported.

Positive

• PRV-002 demonstrated safety and tolerability in Cohort I trials.
• No severe adverse events were reported during the dosing period.
• The trial is being conducted by a reputable clinical research organization.

Negative

• None.

Las Vegas, NV, Aug. 10, 2022 (GLOBE NEWSWIRE) -- Odyssey Health, Inc. (OTC: ODYY), f/k/a Odyssey Group International, Inc., a company focused on developing unique, life-improving medical products, today announces the completion and safety findings from Cohort I of its Multi-Day Ascending Dosing (MAD) arm for its Phase I Clinical Trial. Odyssey’s trial is administering PRV-002, its novel drug to treat concussion, to healthy human subjects. MAD Cohort I subjects were dosed for five consecutive days. The drug, PRV-002 was safe and well tolerated in this cohort.

The trial is being conducted by a leading clinical research organization, Avance Clinical Pty Ltd, through Nucleus Network, a Phase 1 clinical trial provider with multiple sites throughout Australia. Cohort I of MAD included eight healthy human volunteers that received one low dose of intranasal PRV-002 for five consecutive days followed by evaluations for abnormal responses. No severe adverse events were noted as PRV-002 appeared to be well-tolerated.

Dr. Jacob VanLandingham of Odyssey Health, Inc. commented, “As the head of drug development for the PRV-002 concussion treatment, I was very happy to see these positive safety results when dosing for multiple days. 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 has functioned nicely and has been well-tolerated in the clinical setting.”

Concussions represent an ‘unmet’ medical need. Common settings for concussion include contact sporting events, military training and operations, motor vehicle accidents and elderly assistive-living facilities due to falls.

The Phase I MAD clinical trial is ongoing and consists of a total of 16 healthy subjects. The Phase I Single Ascending Dosing (SAD) arm has successfully been completed and was well-tolerated. Odyssey will report additional MAD results as they become available.

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

We encourage our shareholders to visit: http://www.odysseyhealthinc.com or Twitter: @OdysseyHealth1.

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 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.

Inquiries:
Odyssey Health
info@odysseyhealthinc.com

FAQ

What were the findings of Odyssey Health's Phase I clinical trial for PRV-002?

Cohort I reported positive safety results, with PRV-002 being safe and well tolerated.

How many subjects were involved in Cohort I of the PRV-002 trial?

Cohort I included eight healthy human volunteers.

What is the purpose of PRV-002?

PRV-002 is being developed for the treatment of concussions.

Who conducted the clinical trial for PRV-002?

The trial was conducted by Avance Clinical Pty Ltd through Nucleus Network.

What are the next steps for the PRV-002 trial?

The Phase I trial is ongoing, and additional results will be reported as they become available.