Odyssey Health, Inc. (ODYY) Planning Phase 2 Trials of PRV-002 for Unmet Medical Needs in Concussion Therapies

  • Medical costs for concussions total $20 billion in the United States, a need for which there is no FDA-approved treatment
  • The CDC estimates that more than 50% of people suffering a traumatic brain injury become moderately or severely disabled and have shorter life spans
  • Odyssey provides a portfolio of diverse technologies and related medical products to meet the unmet medical needs of concussion and TBI patients

Each year, medical costs in the United States for concussions total $20 billion ($400 billion worldwide). There is a significant unmet medical need for treatments for concussions in the medical landscape, with most diagnosed patients sent home with a standard of care involving rest, analgesics for headaches, and anti-depressants. Repeat concussions can lead to early dementia and Chronic Traumatic Encephalopathy (“CTE”), with the likelihood of athlete head injury recurrence totaling 75% (https://ibn.fm/z6bKU).

Currently, there is no FDA-approved drug treatment for concussions, with the CDC noting that about 50% of people with traumatic brain injury (“TBI”) will experience decline in their daily lives or die within five years of their injury, while 57% will become moderately or severely disabled (https://ibn.fm/f5dvW).

Odyssey Health (OTC: ODYY), a medical technology company focused on lifesaving medical products that offer technological and clinical advantages over current standards of care, is moving forward in its quest to meet the unmet needs of concussion patients. Recently, the company announced that its investigational agent PRV-002, a fully synthetic, nonnaturally occurring neurosteroid intended to treat concussion, was reported to be safe and well tolerated in a small cohort of volunteers. The company is currently in the process of selecting clinical sites and developing the Investigator’s Brochure for a Phase 2 trial (https://ibn.fm/e0DMX).

Odyssey provides a portfolio of diverse technologies, featuring four unique medical products currently in development. The company aims to deliver superior products with enhanced clinical utility and market potential. Beyond concussion treatment, Odyssey plans to develop treatments of related brain injury and neuropsychiatric disorders with other novel neurosteroids within its portfolio. These indications include major depressive disorder, post-traumatic stress disorder (“PTSD”), dementia, generalized anxiety, addiction, amyotrophic lateral sclerosis (ALS – Lou Gehrig’s Disease), and CTE.

The company’s advisory boards play a vital role in developing novel treatments for unmet medical needs. The Scientific Advisory Board consists of James P. Kelly, MA, MD, FAAN, the Executive Director of the Marcus Institute for Brain Health (“MIBH”), and Professor of Neurology at the University of Colorado Anschutz Medical Campus. In addition to Dr. Kelly, the board includes Dallas C. Hack, MD, MPH, FACMPH, COL, US Army. Dr. Hack is also a Brain Health Consultant working with the NCAA, DoD, and Cohen Veterans Bioscience.

In March 2022, Odyssey announced the formation of its Military Advisory Board, which supports Odyssey’s outreach efforts to the U.S. Military regarding funding and clinical sites for the treatment of TBIs. The board consists of current and veteran members of the armed forces, including James “Jim” Linder, Francis “Fran” Beaudette, Paul Toolan, and Tim Szymanski.

The Sports Advisory Board was formed in March 2021 to support the company’s outreach efforts to enhance public awareness of TBIs and concussions, as well as the need for an FDA-approved therapy. The board consists of Steve “Mooch” Mariucci, Kurt Warner, Brett Favre, Abby Wambach, Mark Rypien, and David Ross.

Through its Advisory Boards and Board of Directors, Odyssey is backed by decades of combined experience to further its objectives to meet the needs of patients who are currently without FDA-approved therapies in indications like concussion and TBIs.

As demonstrated in its most recent trial, Odyssey’s device and treatment for concussions, Dr. Hack noted, “The overall low levels of PRV-002 in the blood support the hypothesis that more drug is getting to the brain itself when administered with the intranasal device. If this turns out to be the case, not only can the targeted effects of the drug be more efficacious, but the drug will also likely have fewer potential side effects.” Through this evidentiary analysis, the company is working to commence Phase 2 in the future.

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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