Phase I Trial Advance for Concussion Drug Leads Odyssey Health, Inc. (ODYY) to Prepare to Launch the Efficacy Analysis Stage for its Product

  • Brain concussion injuries have commanded a new level of respect in recent years as military personnel, athletes and care center administrations seek remedies rather than simply encouraging people to “shake off” a hard hit to the head
  • Odyssey Health is advancing clinical trials for its novel PRV-002 drug / device solution for treating concussion patients
  • The company reported completion of four cohorts of testing for safety in human subjects in August, and is preparing to launch Phase II testing that will evaluate the product’s efficacy
  • PRV-002 is administered intranasally where it can be taken up across the blood-brain barrier by the body, helping it to target the area where it is needed most with minimal expression in the blood’s circulation system

Medical solutions innovator Odyssey Health (OTC: ODYY) is preparing to launch Phase II clinical trial testing of its novel brain concussion therapy following successful outcomes in examining its drug’s safety.

Odyssey’s PRV-002 combines a synthetic neurosteroid with an intranasal applicator device to deliver the drug in such a way that it will be taken up into the brain with minimal circulation through the blood system. The drug is lipophilic, which helps it to cross the blood-brain barrier where it needs to go to rapidly eliminate swelling and oxidative stress in the brain in order to maintain proper blood flow to critical parts of the organ.

Odyssey Health has completed a series of lab animal tests involving the company’s proprietary solution and announced this month the successful completion of the first cohort of the multiple ascending dose portion of its Phase I clinical trial analyzing safety of the drug in human volunteers.

The company is finishing up the final stage of its Phase I trial that involves administering high doses of the drug to human patients. Phase II will take a hard look at the efficacy of the drug product by looking at specific outcome measures. (https://ibn.fm/x4TP7).

Concussions, also known medically as mild traumatic brain injury, or mTBI, have come to be taken more seriously in the general public in recent years, particularly as professional athletes have acknowledged a need to prioritize their recovery from significant head impacts over a desire to remain competitive.

NASCAR driver Kurt Busch became one of the latest to acknowledge head injury concerns when he chose to sit out multiple races until he could be assured he was mentally as well as physically recovered from a qualifying round crash in late July.

“Brain injury recovery doesn’t always take a linear path. I’ve been feeling well in my recovery, but this week I pushed to get my heart rate and body in a race simulation type environment, and it’s clear I’m not ready to be back in the race car,” Busch said when he announced he’d miss a fourth race (https://ibn.fm/2YLuF). “This was by far the hardest week emotionally because I do feel the progression of recovery, but racing requires an extreme physical and mental effort, and my body is not 100% able to sustain the intense race conditions.”

Odyssey’s PRV-002 solution aims to eventually be approved for on-site administration at incidents where head injuries occur, such as at athletic competitions. Patients would be treated within the first minutes after the injury happens, allowing them to avoid swelling that might lead to long-term consequences.

Currently there is no U.S. Food and Drug Administration (“FDA”)-approved medication for treating concussions, allowing Odyssey Health to state they are pursuing a novel solution to fulfill an unmet need for millions of people worldwide.

The Phase II trial is expected to include military sites that sustain a high rate of concussion.

“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,” Major General (Ret.) Jim Linder, the former chief of staff for the U.S. Special Operations Command, stated last month in addressing Odyssey’s testing program (https://ibn.fm/q3uBK).”

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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