Odyssey Health, Inc. (ODYY) Completes Successful Phase I Clinical Trial Showing PRV-002 Concussion Drug Candidate was Safe and Well Tolerated

October 6, 2022 08:05:00
  • Odyssey Health is a medical company focused on unique, life-saving medical products that offer clinical advantages to unmet clinical needs
  • With concussion representing a high unmet need as there is currently no FDA-approved drug, Odyssey is developing a drug formulation, PRV-002, to be administered to concussed patients; the drug candidate is currently undergoing clinical evaluation
  • In a recent announcement, the company reported the successful completion of its Phase I clinical trial, which showed that the drug was safe and well tolerated
  • Odyssey is looking to present the findings of the Phase I study to the FDA and is also preparing for the planned Phase II trial

A soft and squishy organ that can be deformed with a simple touch, the human brain is extremely sensitive. And although it is encased in a sturdy skull and surrounded by a cushioning fluid that collectively work to protect it from the external environment and forces that could easily wreak havoc, it is still vulnerable to extremities. In fact, blows, jolts, violent shaking, or rapid decelerations as a result of an accident, for example, can and do override these protections, leading to a mild form of brain injury called mTBI or concussion or mTBI, an area of interest for medical company Odyssey Health (OTC: ODYY).

Concussion Effects

After a concussion, and depending on the concussed individual, the brain undergoes changes triggered by, among others, mechanical damage to neuronal connections, chemical imbalance, and activation of inflammation-inducing immune cells (https://ibn.fm/L7YoI), which cause such harmful responses as swelling, inflammation, and oxidative stress. mTBI also decreases blood flow to the brain, restricting glucose from traveling to the cells. To the concussed patient, these changes manifest in the form of symptoms such as dizziness, blurry vision, nausea and vomiting, headache, confusion, and, in some cases, loss of consciousness (https://ibn.fm/b1RKt).

While most of these symptoms resolve over the course of several weeks to a few months, concussions can cause long-term consequences. For one, a single concussion raises the risk of having another concussion, with the second being more severe (https://ibn.fm/XFZaE). Relatedly, repetitive concussions are associated with the increased likelihood of developing neurodegenerative conditions such as Parkinson’s and Alzheimer’s disease, as well as chronic traumatic encephalopathy (“CTE”) (https://ibn.fm/Zhf00).

PRV-002 Drug-Device Combination

With the concussion space representing a high unmet medical need, given there is currently no FDA-approved drug for the condition, Odyssey Health took the initiative to develop one, guided by the need to nip the harmful responses in the bud before they can trigger severe symptoms. The outcome was PRV-002, a fully synthetic, non-naturally occurring neurosteroid.

The drug formulation is designed to be administered into the upper nasal cavity a few minutes after a concussion, using the company’s patent-pending intranasal delivery device for onward travel to the brain along the cranial nerve. This route of administration, coupled with the drug’s lipophilic characteristics, enables PRV-002 to cross the blood-brain barrier within five minutes and spread throughout the brain within 30 minutes, reversing the harmful responses.

PRV-002 has been the subject of ongoing clinical trials as part of a drug development program that, so far, has included preclinical animal studies and a clinical study. Animal studies evidenced that PRV-002 rapidly eliminates swelling, oxidative stress, and inflammation (https://ibn.fm/7ewOr). Motivated and having fulfilled FDA requirements, Odyssey embarked on the clinical human trial stage, announcing early last Fall that it had begun enrolling subjects for a Phase I trial to treat concussion (https://ibn.fm/p7BjD).

Successful Phase I Clinical Trial

In a recent news release published September 28, Odyssey reported the successful completion of this Phase I clinical trial, noting that the drug was safe and well tolerated throughout the study period (https://ibn.fm/CnRYO). The trial, a double-blinded, randomized, and placebo-controlled study that comprised a total of 40 healthy human volunteers, was segmented into two stages: Single Ascending Dosing (“SAD”) and Multiple Ascending Dosing (“MAD”).

The SAD stage consisted of 24 participants who were separated into three different groups, known as cohorts, and received varying doses of the drug at a ratio of 3:1 with placebo. (The treatment groups were given a low, medium, or high-single dose of PRV-002.) The MAD portion of the trial was made up of 16 subjects, separated into two cohorts, each with eight members. Each subject received a single low or high dose for five consecutive days.

The Safety Review Committee (“SRC”) then monitored the subjects after the dosing of each cohort was complete. No adverse events were noted as the drug was well-tolerated for all the cohorts. Vital signs, EKG readings, sleep patterns, and breathing functions were all normal throughout the study, while blood samples showed no alterations associated with the PRV-002 treatment. Moreover, pharmacokinetic analysis, which revealed significantly lower levels of PRV-002 in the blood than what would be expected with other routes of administration, suggested a greater delivery of the drug formulation to the brain.

“After reviewing the data from each of the cohorts, I have strong confidence that it is safe to proceed to the next clinical trial phase where PRV-002 will be administered for ten consecutive days to subjects following concussion,” commented Dallas Hack, MD, member of the SRC. “Of particular note, the overall low levels of PRV-002 in the blood supports the hypothesis that more drug is getting to the brain itself when administered with the intranasal device. Less systemic exposure with this targeted approach promotes patient safety.”

Odyssey is currently communicating with the FDA to present the findings from the Phase I trial while simultaneously preparing for the planned Phase II trial. More specifically, the company is identifying the Phase II trial sites and is working with its medical advisors to create a study design.

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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