Oragenics announced that it has submitted an Investigator’s Brochure application to Australian authorities seeking the go-ahead for a Phase 2 trial of ONP-002, a dry powder intranasal neurosteroid, for the treatment of mild traumatic brain injury. In 2023, Oragenics acquired ONP-002 from Odyssey Health, which had announced Phase 1 results the previous year. In August 2024, the company said that a pre-clinical study indicated a low potential to cause heart arrhythmias.
According to Oragenics, the Phase 2 study is expected to enroll 40 patients with mild traumatic brain injury who will receive an initial dose of either ONP-002 or placebo within 12 hours of being injured. The patients will then receive another 8 doses over a 5-day period.
Oragenics Interim CEO Janet Huffman commented, “The submission of our Investigator’s Brochure application marks a critical step forward in advancing our clinical program for ONP-002. This submission brings us closer to initiating our clinical trial, and we remain committed to delivering a much-needed therapeutic option for patients suffering from mTBI. We anticipate receiving final regulatory approvals that should allow us to initiate our clinical trial in the coming weeks, and are focused on ensuring a smooth trial launch and look forward to sharing updates as we progress.”
Read the Oragenics press release
