Oragenics Advances to Concussion Treatment Phase II Trial

Oragenics, Inc., a biotechnology firm listed on the NYSE American under the ticker OGEN, is gearing up for a Phase II clinical trial of its innovative drug-device combination therapy for treating mild Traumatic Brain Injury (mTBI), commonly known as concussion. The company's lead candidate, ONP-002, is a novel chemical entity engineered to reach the brain via a self-propelled powdered form administered through the nasal cavity. Encouraging results from a Phase I study involving 40 participants have demonstrated the safety and tolerability of ONP-002.

The company is in the final stages of drug synthesis and formulation for the upcoming Phase II trial, which will involve patients in the acute post-concussion phase. Upon diagnosis, these patients will promptly receive their initial intranasal dose of the treatment.

Dr. James "Jim" Kelly, a neurologist and Executive Director of the Marcus Institute of Brain Health, who is also an advisor for the Phase II trial, emphasized the importance of addressing concussion as a significant medical need. He highlighted the potential of an acute treatment to mitigate the pathological effects of concussions, expressing excitement for the commencement of the trial.

ONP-002 has demonstrated neuroprotective properties and has been shown to improve memory and motor performance in animal models of brain injury. The drug has a considerable safety margin, with dosages used in animal toxicology studies being significantly higher than those in the Phase I study and planned for Phase II. Intranasal administration of ONP-002 as a nanoparticle has been proven to enhance brain exposure in animals. Michael Redmond, President of Oragenics, underscored the company's commitment to improving brain health through intranasal delivery while maintaining a robust safety profile.

Concussions are a prevalent issue, with approximately 69 million cases reported globally each year. They are often caused by falls, motor vehicle accidents, and contact sports. There is a known link between concussions and other neurological disorders such as Alzheimer's Disease, Parkinson's Disease, and Chronic Traumatic Encephalopathy (CTE). Post-concussion syndrome can lead to long-term disability and affects up to 20% of patients who have suffered a concussion.

The company's focus on developing ONP-002 as a potential treatment for concussions underscores the urgent need for effective therapies in this area. With the Phase II clinical trial on the horizon, Oragenics is poised to contribute to the advancement of medical solutions for brain injury patients.