Odyssey Health said that a Phase 1 single ascending dose trial of PRV-002 nasal spray, which it describes as “a fully synthetic non-naturally occurring neurosteroid being developed for the treatment of mTBI (concussion),” has been completed. According to Odyssey, the trial found a linear dose response, and all dose levels were safe and well tolerated. In addition to moving ahead with a MAD trial, the company said that it is scheduling a meeting with the FDA to discuss the Phase 1 results and is making plans for a Phase 2 trial.
Prevacus, the original developer of PRV-002 had announced plans for a Phase 1 trial in 2017. In January 2021, following the company’s involvement in a Mississippi embezzlement scandal, Prevacus announced that it had sold the nasal spray to Odyssey Group International in January 2021.
Safety review committee member Dallas Hack said, “After reviewing the data from Cohort 3 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 1 clinical trial where subjects are treated once daily for five straight days. We have unanimously approved the start of MAD Cohort 1. I am especially excited to see the overall low levels of PRV-002 in the blood supporting 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 the drug will likely have less potential side effects.”
Read the Odyssey Health press release.
