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Odyssey Health, Inc. (ODYY) Marks New Milestone in Pursuit of Concussion Treatment with Positive Safety Findings from Cohort I of Phase 1 Clinical Trial for PRV-002

  • Odyssey Health is a medical company focused on unique, life-saving medical products that offer clinical advantages to conditions with unmet needs
  • The subject of an ongoing Phase I clinical trial, Odyssey’s PRV-002 is a novel compound for treating concussion, which currently has no FDA-approved drug
  • Data from Cohort I of the Phase I study showed that PRV-002 is well-tolerated, with no adverse events being observed
  • The company believes that, if PRV-002 is found to be efficacious for concussed patients in the Phase 2/3 trials, the intranasal brain-targeting will be the key to its success
  • Phase 1 and 2 drugs represent valuable assets, with large companies entering into multimillion and even multibillion-dollar agreements to license drug candidates while they are still undergoing clinical trials

Between 3 and 5 million concussions happen every year in the US alone, though only 1 in 2 cases are reported or detected (https://nnw.fm/9SZNB). Also known as mild traumatic brain injury (“mTBI”), a concussion is caused by a jolt, blow or bump to the head, or a hit to the body that causes the head to shift positions quickly causing the brain to stretch. 

In describing concussion as a complicated injury, a recent Washington Post article notes: “Every concussion is unique, so symptoms and recovery times vary between individuals, even if they were hit with the same force on the same part of their head, experts say” (https://nnw.fm/iFDKn). Moreover, mild concussions can cause long-term health issues eight years after they initially happened, new research conducted in New Zealand has established (https://nnw.fm/dW1lz).

The study, which followed 150 adults after they suffered a concussion, found that “ongoing mental health conditions – including depression – persisted long after injury.” Other reported issues included anxiety and post-traumatic stress disorder (“PTSD”). The research further noted that multiple concussions happening at close intervals could exacerbate the situation as the brain does not get enough time to recover; it concluded that “the lack of intervention or treatment for prior injuries may have meant that another injury was sustained before full recovery, leading to a greater symptom burden.”

Despite the acknowledgment of the need for medical intervention, there is currently no FDA-approved treatment for concussions, representing an unmet medical need. Odyssey Health (OTC: ODYY), f/k/a. Odyssey Group International, Inc., is looking to fill this void. Building on milestones accomplished throughout the second half of 2021, Odyssey recently reported the completion of a safety evaluation of Cohort I of its Phase I clinical trial administering PRV-002, the company’s novel drug treatment for concussion (https://nnw.fm/7rRU1).

Findings from the cohort, which included eight healthy human volunteers that received a single dose of PRV-002 or placebo followed by evaluations for abnormal responses, showed that the participants did not exhibit any severe adverse events as PRV-002 was well tolerated. Vital signs, breathing function, EKG heart readings, and sleep patterns were all normal. Additionally, blood labwork showed no alterations linked to the PRV-002 treatment. Pharmacokinetic analysis was done to ensure that increasing the dose would be safe.

“PRV-002 appears to be well-tolerated when given intranasally. If PRV-002 is found to be efficacious for concussed patients in the Phase 2/3 trials, I believe that intranasal brain-targeting will be the key to its success. So far, the intranasal drug/device combination is holding up well in the clinical setting,” commented Odyssey’s CEO, Michael Redmond. 

The completion of the safety evaluation is the latest milestone as the company journeys toward providing concussion treatment. In late August last year, Odyssey announced it had completed the novel drug-device combination product. The drug formulation, a spray-dried powder formulation, is designed to reduce the harmful response to concussion, which includes oxidative stress, inflammation, and brain swelling. It is administered through breath propulsion into the nose via the company’s nasal drug delivery device, which disperses the active drug throughout the upper portion of the nasal cavity without being inhaled or swallowed, allowing for the drug to travel upward along the cranial nerves, used for smell, for delivery directly into the traumatized brain (https://nnw.fm/hniXw). 

On September 1, Odyssey received approval from the Alfred Ethics Committee to begin a Phase I human clinical trial, following which it began organizing the trial work and enrolling subjects (https://nnw.fm/5VyOt), culminating in the recent announcement. With the Phase I clinical trial, which consists of 48 healthy subjects, ongoing, Odyssey expects to report additional results as they become available. And while the PRV-002 drug candidate may still be undergoing trials, it is a valuable asset for the company, especially considering recent high-value licensing trends. 

For instance, biopharmaceutical company AbbVie Inc. (NYSE: ABBV) and clinical-stage biotechnology Cugene Inc. recently entered into an exclusive worldwide license option agreement for Cugene’s CUG252, a phase 1 drug candidate for the potential treatment of autoimmune and inflammatory diseases. Under the terms of the agreement, AbbVie will part with an upfront payment of $48.5 million, with additional payments due later should it exercise the license option (https://nnw.fm/3K2cn).

In addition, for another phase 1 drug candidate, AbbVie recently ‘back-loaded the acquisition of privately held Syndesi Therapeutics, paying $130 million initially, with the opportunity for shareholders of the Belgium-based company to collect another $870 million if predetermined milestones are achieved” (https://nnw.fm/PS864). 

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://nnw.fm/ODYY

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