- No adverse reactions were reported in any of the healthy subjects enrolled in the Cohort II Phase 1 clinical trial of PRV-002
- Company in talks with military training sites for Phase 2 and 3 clinical trials on concussed patients
- The CDC estimates that approximately 1.6 to 3.8 million sports and recreation-related concussions occur annually, for which there is no FDA-approved treatment
- The global concussion market size was valued at $6.8 billion in 2019. This value is expected to rise to $8.9 billion by 2027, growing at a CAGR of 3.6%
Odyssey Health (OTC: ODYY), a medical company focused on unique, life-saving medical products that offer clinical advantages to unmet clinical needs, has announced positive safety findings from Cohort II of their Phase 1 clinical trial. The company’s Phase 1 trial involves the administration of PRV-002, Odyssey’s novel treatment for concussions, to healthy human subjects. Findings from Cohort II have indicated that the drug is safe and well-tolerated amongst the subjects. Conducted at Nucleus Network, a leading clinical research organization, Cohort II was unblinded and evaluated by the Safety Review Committee.
Cohort II was conducted using six healthy human volunteers, each receiving either one dose of PRV-002 or a placebo. These were followed up by evaluations looking for abnormal responses, which concluded no adverse effects were reported, and the drug was well tolerated. Evaluations included vital sign monitoring, EKG readings, sleep pattern, and breathing function – which were all normal. Labs indicated there were no alterations associated with the PRV-002 treatment.
“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,” Odyssey Health CEO Michael Redmond said (https://ibn.fm/U8T8X). “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 1 trial is ongoing and has 40 healthy subjects administered a single ascending dose and a multi-ascending dose component. Odyssey is currently going through the process of scheduling a meeting with the FDA to present the findings from the Phase 1 trial. The company will report additional findings as they become available.
“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,” said Dallas Hack, MD, a member of the Safety Review Committee. “No abnormalities were seen, and we have unanimously approved the next cohort where the treatment dose will be doubled.”
Concussions are a mild form of traumatic brain injury. They are caused by a bump, blow, or jolt to the head or body that causes rapid brain movement inside the skull. Even the slightest concussion can change the brain’s normal functions. According to the CDC, an estimated 1.6 to 3.8 million sports and recreation-related concussions occur annually in the United States (https://ibn.fm/a0Ozl).
The global concussion market size was valued at $6.8 billion in 2019. Due to the rising number of accidents and sports injuries, this number is expected to grow at a CAGR of 3.6% from 2020 to 2027, resulting in a value of $8.9 billion by 2027. The leading causes of concussions in the United States include falls (52%), motor vehicle-related injury (20%), being hit by or colliding with an object (17%), and assaults (11%) (https://ibn.fm/II4pK).
Odyssey’s PRV-002 is a new chemical entity, Proprietary Neurosteroid, with proven in-vivo efficacy in animal concussion models through gene amplification of anti-inflammatories, anti-oxidants, and efflux fluid channels. The administration nasally allows for the drug to reach the brain in a matter of minutes. PRV-002 is Odyssey’s solution for a medical need that currently has no FDA-approved treatment.
For more information, visit the company’s website at https://odysseygi.com/.
NOTE TO INVESTORS: The latest news and updates relating to ODYY are available in the company’s newsroom at https://ibn.fm/ODYY