Oragenics Inc. (NYSE American: OGEN) has announced the activation of all three sites in its Australian Phase IIa clinical trial of ONP-002 for mild traumatic brain injury (concussion), following the activation of Royal Adelaide Hospital. The company confirmed that 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.
In a separate development, Oragenics 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 stated that the meeting supports its goal of submitting an Investigational New Drug (IND) 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's platform has potential applications across multiple neurological conditions, including Parkinson's disease, Alzheimer's disease, PTSD, and anxiety disorders.
For the full press release, visit https://ibn.fm/Yye2E. More information about Oragenics is available at oragenics.com.
Oragenics is a clinical-stage biotechnology company developing brain-targeted therapeutics. The company is committed to addressing significant unmet medical needs in neurological care through innovative therapies.
