- Players and military service members often retire with debilitating traumatic brain injuries (“TBIs”), including concussions, that lessen the quality of life and present neurological problems as they continue to age
- Odyssey has developed PRV-002, a novel compound for treating concussion, and a novel breath-propelled nasal delivery device for delivering the drug deep into the nasal cavity
- The PRV-002 drug is expected to offer reprieve to people suffering from concussion by potentially preventing long-term consequences of the condition
- The drug is currently undergoing evaluation as part of a Phase I study that has so far shown that it is well tolerated
- Planned Phase II/III studies will investigate PRV-002’s efficacy for concussed patients
In a recent interview with RedChip Companies, Pro Football Hall of Famer Brett Favre, who headlines the sports advisory board of medical company Odyssey Health (OTC: ODYY), expounded on an earlier statement in which he had described his career as “kind of a blessing and a curse” (https://ibn.fm/99y4P). Favre attributed the “curse” aspect to the injuries and concussions he suffered while playing football, which, he fears, could give rise to neurological problems as he grows older.
“You can get knees, ankles, or hips fixed or replaced [after an injury], and they’re nagging injuries, but we’re just scraping the tip of the iceberg of what concussions can do to anyone, not just football players. So, that’s the curse part of it – there’s no answer, there’s no solution to concussions other than [not suffering a concussion],” Favre told RedChip Companies’ Craig Brelsford (https://ibn.fm/2atrt).
Many share Favre’s concern about the lack of FDA-approved concussion treatment, including Odyssey Health, which is looking to change this narrative, offering relief to people who also hold a position similar to the Hall of Famer. As part of its focus on unique, life-saving medical products that offer clinical advantages to unmet clinical needs, Odyssey has developed, among other products, PRV-002, a novel compound for treating concussion, and a patent-pending novel breath-propelled nasal delivery device.
“Odyssey’s breath-powered nasal device is equipped with a novel dual wall drug dispensing system that creates a unique dual airflow for depositing concentrated drug deep into the nasal cavity and onto the olfactory region for direct diffusion into the brain for the treatment of nasal and/or central nervous system (‘CNS’) injury, disease or disorder, especially brain injury, such as traumatic brain injury (‘TBI’), namely, concussion,” the company explained in an October 2021 press release (https://ibn.fm/60CUI). Put simply, the nasal delivery device is designed to deliver PRV-002.
According to Odyssey CEO Michael Redmond, the device affords Odyssey the ability to get PRV-002 into the brain rapidly after a concussion. This, coupled with the drug’s minimal side effects, if any, he said, will be instrumental to the company’s success in its clinical trial. And having recently completed Phase I Single Ascending Dosing (“SAD”) clinical trial in which the company established that PRV-002 was safe and well tolerated, Odyssey is even more optimistic that the drug will continue to show safety during the Multiple Ascending Dosing (“MAD”) portion of the Phase I clinical trial (https://ibn.fm/4qPkQ).
The positive results set the stage for the planned Phase II clinical trials, which Odyssey expects to begin immediately upon receiving Phase I data and regulatory approval, according to Redmond’s earlier interview with RedChip Companies (https://ibn.fm/XUsu5). Odyssey is identifying Phase II trial sites while simultaneously creating a study design with the help of a team comprising the company’s medical leadership and advisors. The Phase II study aims to determine the efficacy of PRV-002 for concussed patients.
With the potential to be available and commercialized to Special Populations such as the military, which experience concurrent disease states (concussions), immediately after a successful Phase II trial, the drug is poised to potentially offer much relief to not only service members but also players and the general population. “We need a treatment to prevent long-term consequences of concussion as far too many of our Service Members are retiring with TBI disorders that lessen their quality of life,” commented Major General(R) Jim Linder, a member of Odyssey’s Military Advisory Board.
As the company’s drug development journey progresses toward the planned Phase II study, one cannot help but notice the value the drug potentially holds. This value is anchored not only in the fact that there’s currently no FDA-approved concussion treatment but also in the fact that companies are spending large sums of money to license novel drug candidates or partner with developers of novel drugs that are still in the early stages of testing and development.
For instance, this year, AbbVie Inc. (NYSE: ABBV) partnered with Plexium, Inc. to develop and commercialize a novel treatment for neurological conditions (https://ibn.fm/nNezj). This followed on the heels of an announcement in which AbbVie extended an earlier collaboration that saw it license Dragonfly Therapeutics, Inc.’s first drug candidate developed using the latter’s TriNKET(TM) technology (https://ibn.fm/77EJQ).
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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