- Odyssey successfully completed the second Cohort of its Phase I MAD clinical trial, proving the safety profile of its concussion pharmaceutical treatment, PRV-002
- This study built on the success of Cohort I, where the drug was well tolerated and proved safe, with no severe adverse events reported
- The company’s Phase I Single Ascending Dose (“SAD”) cohorts of the clinical trial closed on July 12, 2022, proving the drug was safe and well tolerated. Results from this study were well received by the SRC, who also expressed their optimism for Odyssey’s completion of the MAD portion of its Phase I trial and subsequent Phase II and III studies
- Odyssey looks to offer a viable solution for treating concussions, regarded as a significant “unmet” medical need. It also looks to capitalize on a growing market projected to be valued at $8.9 billion by 2027
Odyssey Health (OTC: ODYY), an enterprise committed to developing unique, life-enhancing medical products, marked a successful close of the second Cohort of its Phase I Multi-Day Ascending Dosing (“MAD”) clinical trial (https://ibn.fm/pnUwS).
While making the announcement, Odyssey’s Chief Executive Officer (“CEO”), Michael Redmond, expressed how pleased he was with the safety profile of the company’s concussion pharmaceutical treatment, PRV-002.
“As we come close to completing the Phase I trial, I am very pleased with the safety profile of our concussion pharmaceutical treatment, PRV-002,” he noted.
“I’m equally pleased that the intranasal drug/device combination has functioned nicely and has been easy to operate in the clinical setting,” he added.
Odyssey’s trial involved administering its novel drug to treat concussions, PRV-002, to healthy human subjects to determine drug safety. A total of 40 healthy subjects took part in the study. In Cohort I, eight patients received a low dose of the drug, and in Cohort II, patients received a high dose of the drug. The second Cohort reflected the success of the first, where the drug was well tolerated and proved safe with no severe adverse events reported.
On July 12, 2022, Odyssey announced the successful completion of its Phase I Single Ascending Dosing (“SAD”) clinical trial, which also involved administering PRV-002. This study proved that the drug was safe and well tolerated and would lay the foundation for the currently-ongoing MAD clinical study (https://ibn.fm/vSh7h).
At the time, Dallas Hack, the Managing Director (“MD”) and member of the Safety Review Committee (“SRC”), reckoned:
“After reviewing the data from Cohort III and completing the SAD analysis, I have strong confidence that PRV-002 will continue to show safety during the Multiple Ascending Dosing (‘MAD’) portion of the Phase I clinical trial where subjects are treated once daily for five straight days.”
Philip Ryan, the MD and Principle Investor for Nucleus Network, noted:
“PRV-002 was well-tolerated throughout the SAD portion of the Phase I trial. The SRC has confidence about the safety of the intranasal delivery of PRV-002.”
“We look forward to completing MAD portion of the Phase I trial and assisting Odyssey with their Phase II/III design to determine the efficacy of PRV-002 for concussed patients,” he added.
Odyssey, so far, has lived up to its expectations and those of the SRC, proving the overall safety of its novel drug. With concussions representing a significant “unmet” medical need affecting millions worldwide, the company is inching closer to offering a viable solution that will benefit patients. In addition, it is positioning itself to take advantage of an industry projected to be valued at $8.9 billion by 2027, up from $6.9 billion in 2020 (https://ibn.fm/LNyM3).
Odyssey is currently in the process of selecting clinical sites and developing the Investigator’s Brochure for the Phase II trial. As of July 2022, the company was still in discussions with military training sites for Phase II and III clinical trials, which it hopes to kick off later this year.
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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