- 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…
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