- Odyssey Health is focused on developing life-saving medical products and pharmaceutical assets that offer a technological and clinical advantage
- The company is developing the CardioMap Heart Monitoring and Screening Device and the Save-a-Life choking rescue device
- Its drug-device combination is intended to get PRV-002, Odyssey’s novel treatment for concussion, to the brain rapidly after concussion
- In an interview with RedChip Companies CEO Dave Gentry, Odyssey CEO Michael Redmond outlined the timelines under which the company is operating as it eyes the commercialization of its novel drug candidate
Medical company Odyssey Health (OTC: ODYY) is working to provide life-saving medical solutions that offer clinical advantages to unmet medical needs. The company boasts a repertoire of several products that include the CardioMap Heart Monitoring and Screening Device and the Save-a-Life choking rescue device, both of which are in development and are, therefore, not yet commercially available, as well as a novel breath-propelled nasal delivery device designed to deliver the company’s novel treatment for concussion, PRV-002.
Nasal Delivery Device
The nasal delivery device, which was the subject of a patent application filed last fall (https://ibn.fm/9c2KZ), is part of a drug-device combination that is being used in Odyssey’s ongoing Phase I clinical trial investigating how well PRV-002 is tolerated by healthy human subjects. “It’s a small device that essentially delivers a powdered drug through the upper chambers of the nasal cavity. The drug crosses the blood-brain barrier within 5 minutes and spreads out throughout the brain within 30 minutes, reversing the effects of a concussion,” explained Odyssey CEO Michael Redmond in a recent interview with RedChip Companies CEO Dave Gentry (https://ibn.fm/Pz8SE).
The device provides Odyssey with the opportunity to get PRV-002 into the brain rapidly after a concussion, a factor that, coupled with the drug’s safety profile and lack of adverse side effects as indicated by extensive animal trials and initial results from a section of the participants in the Phase I clinical trial, will be instrumental to the company’s success in its clinical trials.
PRV-002 Novel Drug Candidate
Developed by two neuroscientists, one of whom has a background as a toxicologist, PRV-002 is a compound that Redmond described as a drug cocktail containing three new, proprietary elements that have three mechanisms of action. “Between the two of them, having both toxicology and neurological backgrounds, they created an extremely safe drug compound. We did animal studies that show even at 200 times what we believe to be the dosing, there’s still no toxicity. So, it’s an extremely safe drug, and the efficacy in the animal models is very strong. We have confidence that this will translate into humans,” Redmond continued.
The PRV-002 drug is designed to be administered as close to a concussion event as possible, with quicker administration leading to better results. Odyssey has established that there is a window of at least six hours within which the drug shows greater efficacy, if administered.
To boost the chances of greater efficacy from quick administration, the PRV-002 drug candidate is available as a dry powder with a long shelf life and does not require special handling or refrigeration. For this reason, it can sit on the sidelines of any football game or sporting event. In addition, soldiers, who are at great risk of suffering blunt trauma from explosives’ shockwaves, bullet penetration, and violent impact, can store it in their backpacks, while emergency response teams can keep it in their ambulances or emergency rooms (“ERs”).
When asked how quickly the company expects to begin Phase II clinical trials given the ongoing Phase I clinical trial, Redmond noted, “When we have the Phase I data, we can actually start a Phase II trial in Australia immediately. We have a site set to start a Phase II trial in Australia, likely in the October timeframe. We want to do some of the Phase II or most of it in the U.S., and that requires FDA approval. We have reached out to the FDA to set up that meeting, and hopefully, we’ll have a meeting with the FDA where we can provide our Phase I data in the summer timeframe.”
The company is in discussions with the military in the U.S. to undertake the Phase II study at some of the military sites that experience a large number of concussions and has, in fact, formed a Military Advisory Board to help it achieve this goal (https://ibn.fm/j4LAw). Odyssey expects to “be in the U.S. Phase II [clinical trial stage] this year, probably in the fourth quarter,” subject to FDA approval.
Odyssey has strategically planned its Phase II trial to ensure it collects data as soon as the study commences. According to Redmond, the ability to gather data is a function of the number of concussed patients, meaning the company has to set trials at sites that report a high number of concussions. For example, the military has at least two sites that experience over 100 concussions a month. And by setting up the trials at these sites, the company expects to start collecting data immediately upon the start of the trial.
Redmond also highlighted the subsequent phases of its drug development journey, noting that the drug could be available for commercialization to Special Populations – a group of people, in this case, the military, that experiences concurrent disease states (https://ibn.fm/O9jh7) – immediately after a successful Phase II trial. That’s because there is currently no FDA-approved treatment for concussion. To facilitate this milestone, Odyssey would be open to partnerships for commercialization, marketing, and distribution.
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
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