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 reported that no serious adverse events have occurred 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 disclosed that it submitted a Type B meeting request to the U.S. Food and Drug Administration (FDA) on June 26 to seek 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.
ONP-002 is a potential first-in-class treatment for concussion and mild traumatic brain injury, delivered via Oragenics' proprietary intranasal delivery technology. This platform has potential applications across multiple neurological conditions, including Parkinson's disease, Alzheimer's disease, PTSD, and anxiety disorders.
According to the press release, the company is committed to developing innovative therapies that address significant unmet medical needs in neurological care. For more information, visit oragenics.com.
The full press release can be accessed at https://ibn.fm/Yye2E.
