- Medical technology innovator Odyssey Health Inc. is using clinical tests to establish the safety of a therapy designed to treat concussion injuries in its earliest moments
- The company is enthused by results from the early-stage testing and is preparing to design a Phase II/III trial that will target efficacy results in volunteer subjects, focusing particularly on members of the military
- Odyssey’s technology combines a synthetic medication with a specially designed application device that helps the medication cross the blood-brain barrier for immediate responsiveness following a mild traumatic brain injury (“mTBI”)
- Medication for concussion treatment remains an unmet need and Odyssey is aiming to be a first-mover in the healthcare sector
The National Council on Aging sponsors its Falls Prevention Week timed, not ironically, during the fall of each year, using its national health campaign to combat the leading cause of fatal and non-fatal injuries among older adults.
One message of the council’s awareness campaign is the importance of recognizing that after an old person is helped back up, the fall victim may be able to resume walking, but there is still a significant risk of worsening effects from a concussion-related head injury (https://ibn.fm/rRsst).
While the potential harm of concussion injuries in youth sports and among professional athletes is gaining an increasing measure of attention, concussions in elderly fall patients is also a prominent concern, and active military personnel also continue evaluating potential new treatments for concussion injuries sustained on duty.
Medical device innovator and biopharmaceutical product developer Odyssey Health (OTC: ODYY) is working to address unmet needs in concussion therapy, to help patients beyond the standard of care for pain management, rest, and monitoring.
A proprietary device and synthetic medication combination developed by Odyssey Health is being tested for safety related to treating concussion patients in the initial moments after a mild injury, successfully completing all three cohorts in the company’s Phase I Single Ascending Dosing (“SAD”) clinical trial recently and advancing to a Multiple Ascending Dosing (“MAD”) stage in which volunteers will be treated once daily for five straight days.
“We have a very unique new chemical entity intended to treat mild traumatic brain injury — the acute phase of a concussion,” CEO Michael Redmond said during an interview with The RedChip Money Report(R) last month. “It’s a small device. It essentially goes and delivers a powderized drug through the upper chambers of the nasal cavity. The drug crosses the blood-brain barrier within five minutes. It spreads out throughout the brain within 30 minutes and reverses the effects of a concussion” (https://ibn.fm/sdVcJ).
The SAD and MAD clinical trials work with healthy human volunteers to establish the safety of Odyssey Health’s technology, which previously completed preclinical lab animal testing successfully and is expected to advance to a Phase II/III design that will determine the efficacy of the company’s PRV-002 technology for concussed patients.
Phase II trial sites are already being identified and the study’s design is being created, working with military board advisers while company officials report their early efforts to the FDA.
“We are actively identifying and assisting with Phase II military trial site setup,” Major General (Ret.) Jim Linder, the former chief of staff for the U.S. Special Operations Command, stated in a July 12 news release about Odyssey’s progress (https://ibn.fm/VLE3Q). “We need a treatment to prevent the long-term consequences of concussion as far too many of our Service Members are retiring with TBI disorders that lessen their quality of life.”
A significant target of the therapy involves getting the drug across the blood-brain barrier to directly deal with the central nervous system consequences of a head injury.
“I am especially excited to see the overall low levels of PRV-002 in the blood supporting the hypothesis that more drug is getting to the brain itself when administered with the intranasal device”, Safety Review Committee member Dallas Hack, MD, stated after analyzing the SAD trial. “If this turns out to be the case, not only can the targeted effects of the drug be more efficacious, the drug will likely have less potential side effects.”
For more information, visit the company’s website at www.OdysseyHealthInc.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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