Odyssey Health, Inc. Announces Successful Completion of Phase I Clinical Trial for Concussion Drug

Las Vegas, NV, Sept. 28, 2022 — McapMediaWire — Odyssey Health, Inc. (OTC: ODYY), f/k/a Odyssey Group International, Inc., a company focused on developing unique, life-enhancing medical products, today announces the completion of all cohorts for its Phase I Single Ascending Dosing (SAD) and Multiple Ascending Dosing (MAD) clinical trial. Odyssey’s trial involved administering PRV-002, the Company’s novel drug to treat concussion, to healthy human subjects. Throughout the trial, the drug was safe and well tolerated.

The Phase I trial was conducted at Avance Clinical and Nucleus Network, two leading clinical research organizations. The trial consisted of a total of forty (40) healthy human volunteers. The trial was double-blinded, randomized and placebo controlled. For the SAD component twenty-four (24) subjects were separated into three (3) different groups and received drug at a ratio of 3:1 with placebo. The treatment groups were given either a low, medium, or high-single dose of PRV-002. For the MAD portion there were sixteen (16) subjects separated into two groups of eight and each subject received a single low or high dose for five (5) consecutive days. Following each cohort, the subjects were monitored by the Safety Review Committee (SRC). No severe adverse events were noted as PRV-002 was well-tolerated for all cohorts. No delays were instituted between cohorts. Vital signs, EKG readings, sleep patterns and breathing function were all normal through the entirety of the study. Blood labs showed no alterations associated with the PRV-002 treatment. Pharmacokinetic analysis showed a direct linear relationship between drug dosing concentration and blood plasma levels across all cohorts. Blood levels of PRV-002 were significantly lower with intranasal administration to what would be expected with other routes, suggesting a greater delivery to the brain. Read More