- Medical company Odyssey Health has received approval from the Safety Review Committee to start Cohort II of its Phase I trial’s Multiday Ascending Dosing (“MAD”) stage
- The approval follows evidence that Odyssey’s PRV-002 concussion drug candidate was safe and well-tolerated, as seen in Cohort I of the MAD stage
- The pharmacokinetic analysis also supports the hypothesis that more drug is getting to the brain itself, backing the company’s use of its patent-pending breath-propelled intranasal drug administration device
- The company believes that the intranasal drug/delivery combination will be instrumental in the success of the PRV-002 drug candidate in planned Phase II/III trials
Odyssey Health (OTC: ODYY), a medical company focused on unique, life-saving medical products that offer clinical advantages to unmet clinical needs, has received approval from the Safety Review Committee to proceed with dosing and evaluation of Cohort II volunteers of the Multiday Ascending Dosing (“MAD”) stage of its ongoing Phase I clinical trial. Aimed at evaluating the safety and tolerability of the company’s novel drug candidate to treat concussion, PRV-002, the Phase I study involves healthy human volunteers who receive a dose of the drug.
“After reviewing the data from MAD Cohort I, I have strong confidence that PRV-002 will continue to show safety during the final, high-dose MAD portion of the Phase I clinical trial. We have unanimously approved the start of MAD Cohort II,” Dallas Hack, MD, a member of the Safety Review Committee, told Neurology Live (https://nnw.fm/I0qPA).
In an August 10 news release, Odyssey announced the completion and safety findings from Cohort I, showing that PRV-002 was safe and well tolerated. The Cohort 1 of the MAD stage included eight healthy human subjects who received a low dose of intranasal PRV-002 for five consecutive days, followed by evaluations for abnormal responses. No severe adverse events were observed (https://nnw.fm/7S7ru).
Additionally, pharmacokinetic (“PK”) analysis of the data from the first Cohort provided new information that, Hack underlined, support the hypothesis that more drug is getting to the brain itself rather than the circulation. The PK analysis evidenced a direct linear relationship between drug dosing concentration and blood plasma levels. This means that the drug dosing concentration (amount of drug in the body) increased with a rise in blood plasma levels (concentration of the drug in the plasma).
The PK analysis further showed that the blood levels of the intranasally administered active drug were substantially lower on average than what would ordinarily be expected with other routes of administration. Moreover, the evaluations did not reveal any appreciable accumulation of PRV-002 with consecutive day treatments, and the MAD did not alter blood samples.
“The overall low levels of PRV-002 in the blood support the hypothesis that more drug is getting to the brain itself when administered with the intranasal device. If this turns out to be the case, not only can the targeted effects of the drug be more efficacious, but the drug will also likely have fewer potential side effects,” Hack continued.
Hacks’ observation is consistent with separate comments by Odyssey Health CEO Michael Redmond and the company’s Head of Drug Development, Dr. Jacob VanLandingham. In an interview with the RedChip Companies published on YouTube (https://nnw.fm/yO6wb), Redmond said the breath-propelled intranasal device, which delivers a powderized drug through the upper chambers of the nasal cavity, enables the drug to cross the blood-brain barrier within five minutes, following which it “spreads out throughout the brain within 30 minutes and reverses the effects of a concussion.”
On his part, Dr. VanLandingham believes intranasal brain-targeting will be instrumental in the success of PRV-002 should it be efficacious for concussed patients in the planned Phase II/III trials. The Phase II study is intended to evaluate the efficacy of PRV-002 in concussed patients. “So far, the intranasal drug/device combination has functioned nicely and has been well-tolerated in the clinical setting,” concluded Dr. VanLandingham.
Odyssey is now looking to commence its Phase II clinical trial subject to the submission of the Phase I trial results and approval by, among other relevant regulatory bodies, the U.S. Food and Drug Administration (“FDA”). To that end, the company is currently scouting for clinical sites in collaboration with the U.S. military and developing the Phase II Investigator’s Brochure for the Phase II trial.
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://nnw.fm/ODYY
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