Oragenics Inc. (NYSE American: OGEN) announced that all three sites in its Australian Phase IIa clinical trial of ONP-002 for mild traumatic brain injury (concussion) are now active and enrolling participants following the activation of Royal Adelaide Hospital. The company said no serious adverse events have been reported in dosed participants to date and it continues to target a Phase IIa data readout in the fourth quarter of 2026.
Oragenics also announced it submitted a Type B meeting request to the U.S. Food and Drug Administration on June 26 to obtain guidance on its planned U.S. clinical development program for ONP-002. The company said the meeting supports its goal of submitting an Investigational New Drug application in the fourth quarter of 2026.
ONP-002 is a potential first-in-class treatment for concussion and mild traumatic brain injury, delivered via Oragenics' proprietary intranasal delivery technology. The company believes this platform has potential applications across multiple neurological conditions, including Parkinson's disease, Alzheimer's disease, PTSD, and anxiety disorders.
For more details, see the full press release at https://ibn.fm/Yye2E and visit Oragenics' newsroom at https://ibn.fm/OGEN.
