Oragenics announced that a GLP human Ether-à-go-go-Related Gene study conducted by Charles River Laboratories found that ONP-002, an intranasal neurosteroid, would likely not cause heart arrhythmias. ONP-002 is a new chemical entity formulated as a dry powder and delivered via a breath-activated nasal delivery device. The nasal powder is in development for the treatment of mild traumatic brain injury.
Oragenics acquired ONP-002 (previously PRV-002) in October 2023 when it acquired nasal delivery technology from Odyssey Health, which had acquired PRV-002 from Prevacus in 2021. In September 2022, Odyssey announced results from a Phase 1 trial of PRV-002 that it said supported advancing the product into Phase 2 development.
Oragenics President Michael Redmond commented, “We are pleased that ONP-002 has demonstrated a strong safety margin for the heart, enabling us to continue planning the Phase 2 trials. Safety remains our top priority, and we will continuously monitor all safety parameters throughout the trials. Furthermore, a Phase 2 study is being planned to further evaluate the drug in concussed patients.”
Read the Oragenics press release.
