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 stated 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 addition to the trial progress, 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 noted that the meeting supports its goal of submitting an Investigational New Drug application in the fourth quarter of 2026. This regulatory step is crucial for advancing the drug candidate toward potential approval in the United States.
ONP-002 is being developed as a potential first-in-class treatment for concussion and mild traumatic brain injury, leveraging 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. The activation of all Australian trial sites marks a significant milestone in the clinical development of ONP-002.
The full press release is available at https://ibn.fm/Yye2E. For more information about Oragenics, visit oragenics.com.
