Pharma Focus Europe

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

Thursday, September 29, 2022

Odyssey Health, Inc., formerly known as Odyssey Group International, Inc., a company dedicated to developing innovative medical products that improve lives, is pleased to announce the successful completion of all cohorts in its Phase I clinical trial for the drug PRV-002, designed to treat concussions. The trial involved the administration of PRV-002 to healthy human subjects and demonstrated that the drug was safe and well tolerated.

The Phase I trial was conducted at leading clinical research organizations, Avance Clinical and Nucleus Network. A total of forty (40) healthy volunteers participated in the trial, which was double-blinded, randomized, and placebo-controlled. In the Single Ascending Dosing (SAD) component, twenty-four (24) subjects were divided into three (3) groups and received different doses of PRV-002 or a placebo. For the Multiple Ascending Dosing (MAD) portion, sixteen (16) subjects were divided into two groups and received low or high doses of PRV-002 for five (5) consecutive days. Throughout the trial, a Safety Review Committee (SRC) closely monitored the subjects, and no severe adverse events were observed. Vital signs, EKG readings, sleep patterns, and breathing function remained normal, and blood labs showed no abnormalities associated with PRV-002 treatment. Pharmacokinetic analysis revealed a direct linear relationship between drug concentration and blood plasma levels across all cohorts. Notably, intranasal administration of PRV-002 resulted in significantly lower blood levels compared to other routes, suggesting enhanced delivery to the brain.

Dr. Dallas Hack, a member of the Safety Review Committee, expressed confidence in the data and stated that it is safe to proceed to the next phase of the clinical trial, where PRV-002 will be administered for ten consecutive days to patients following a concussion. Dr. Philip Ryan, the Principal Investigator for Nucleus Network, emphasized the well-tolerated nature of PRV-002 throughout the Phase I trial and expressed confidence in the safety of intranasal delivery. The development of PRV-002 will now progress to Phase II/III, where its efficacy in treating concussed patients will be assessed.

Recognizing the significance of concussions, especially in the armed forces, Odyssey is collaborating with the United States military to identify sites for the Phase II trials. Retired Commanding General of the U.S. Army Special Operations Command, Francis Beaudette, expressed enthusiasm about the safety of Odyssey's drug and emphasized the need for effective treatments to prevent the long-term consequences of concussions in military personnel.

Odyssey is currently in communication with the Food and Drug Administration (FDA) to present the findings from the Phase I Trial. Phase II trial sites are being identified, and study design is being developed in collaboration with medical leadership at these sites and Odyssey's Medical Advisors. Concussions represent an unmet medical need with a significant global market valued at $6.9 billion in 2020 and projected to reach $8.9 billion by 2027, according to Grandview Research. Concussions commonly occur in contact sports, military training, motor vehicle accidents, childhood play, and elderly care facilities due to falls.

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