• Odyssey is a medical company developing PRV-002, a novel compound for the treatment of concussion
• Between 75-83% of all the cases of traumatic brain injury (“TBI”) among U.S. service members have been classified as mild (“mTBI”), commonly termed “concussion”
• Although concussion greatly impacts the military, there are significant gaps in the understanding of the optimal diagnostic, treatment, and management criteria
• Odyssey is looking to bridge this informational gap with its clinical trial and intends to start its U.S. Phase II trials at military training sites, subject to the FDA’s approval of the results of its Phase I study

The Center for Disease Control (“CDC”) notes that more than 430,000 U.S. service members were diagnosed with a traumatic brain injury (“TBI”) between 2000 and 2020 (https://ibn.fm/6Yycd), with 75-83% of all these cases being mild (“mTBI”), according to different studies (https://ibn.fm/0MQas). These statistics make mTBI, also known as concussion, the most common TBI affecting military personnel. But despite its prevalence, mTBI is the least understood and most difficult to diagnose of the different forms of TBI and has been a largely unexplored area of medical intervention until very recently.

In military settings, head injuries caused by shock waves from explosives, violent impact, or ballistic penetration are cited as the main causes of TBI, with most concussions resulting from blunt trauma. While symptoms from a concussion are “usually self-limited and resolve spontaneously over a period of a few weeks, 10-15% of individuals develop prolonged symptoms or postconcussive syndrome (‘PCS’)… Neuropsychological testing in PCS may reveal persistent, yet subtle cognitive deficits, often in the executive domain” (https://ibn.fm/kRQxc).

“Despite the impact that concussion has on military service members, significant gaps remain in our understanding of the optimal diagnostic, management, and return to activity/duty criteria to mitigate the consequences of concussion. Specifically, there is insufficient evidence supporting the objectivity (i.e., sensitivity and specificity) of our assessment measures, the optimal treatment strategies to mitigate the impact of concussion, and our ability to predict longer-term outcomes following injury,” writes a 2020 journal article (https://ibn.fm/bjkKe).

This is despite the enactment of the Traumatic Brain Injury Act of 2008, which, among other things, mandated state traumatic brain injury surveillance systems, including the CDC and the Department of Defense (“DoD”), to link individuals with TBI to services and supports (https://ibn.fm/z3jnu). Even more concerning, there is currently no FDA-approved treatment for concussion.

In understanding the severity of concussion among service members and the existing gaps in concussion treatment, Odyssey Health (OTC: ODYY) is working to develop treatments for concussion and other neurological disorders. Odyssey is developing the PRV-002, a novel, fully synthetic, non-naturally occurring neurosteroid for the treatment of concussion that is the subject of ongoing Phase I clinical trials.

PRV-002 has undergone preclinical studies, which suggest that the drug has “equivalent, and potentially superior, neuroprotective effects compared to related neurosteroids. In animal models of concussion, PRV-002 reduced the behavioral pathology associated with brain injury symptoms such as short-term memory loss, depression/anxiety-like behavior, motor-sensory impairment” (https://ibn.fm/XYRCk).

Last fall, Odyssey received international approval to start Phase I human clinical trials (https://ibn.fm/y0nAN) designed to test for drug safety, tolerability, and concentration in both the urine and blood as dosing increases. The Phase I trials comprise 40 healthy subjects segmented into five cohorts, each with eight participants. Odyssey and its research partners will report and approve trial data for continuation after each cohort is completed, with the next group receiving an increased dose if no abnormalities are observed in the preceding cohort. 

Data from a recently completed safety evaluation of cohort I revealed that PRV-002 is well-tolerated, meaning no severe adverse events were noted. Encouraged by the positive results from the preclinical and the ongoing Phase I study, Odyssey has set sights on Phase II clinical trials in the U.S., which will initially focus on the military.

“Based on our animal data and after reviewing our initial Phase I trial safety reports, we are optimistic that PRV-002 will be a safe option for the treatment of concussion. We look forward to completing the Phase I trial and presenting our findings to the FDA. Following FDA review, we intend to initiate a Phase II clinical trial in the U.S., starting with our military. We have created a military advisory board to assist with this effort,” commented Odyssey CEO Michael Redmond in a May 5 news release announcing positive results from a section of cohort I participants (https://ibn.fm/156KR).

Odyssey’s decision to focus the initial attention of its Phase II clinical trial on the military appears to be a timely intervention aimed at filling gaps in the treatment of concussions among service members. This aligns with its commitment to providing unique, life-saving medical products that deliver clinical advantages to unmet needs.

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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