Odyssey Health announced that it has completed its Phase 1 study of PRV-002, a novel intranasal synthetic neurosteroid powder formulation that the company is developing for the treatment of concussion, and said that the results support advancing PRV-002 into Phase 2 trials. Odyssey acquired PRV-002 from Prevacus in January 2021. The company recently announced that the nasal powder was found to be safe and well-tolerated in the SAD portion of the Phase 1 trial.
PK data from the Phase 1 trial, which enrolled 40 healthy volunteers, demonstrated a linear dose response and plasma levels “significantly lower with intranasal administration to what would be expected with other routes, suggesting a greater delivery to the brain,” the company said. No serious adverse events were observed.
Principal Investigator Philip Ryan of Nucleus Network said, “PRV-002 was well-tolerated throughout the Phase 1 trial. The SRC has confidence about the safety of the intranasal delivery of PRV-002. We look forward to following the development process of Odyssey’s drug, PRV-002, during Clinical Phase 2/3 as they determine the efficacy of PRV-002 for concussed patients.”
Read the Odyssey Health press release.
