Oragenics prepares ONP-002 for clinical trials to treat concussion

Oragenics announced it is preparing to undertake the final steps of GMP manufacturing and formulation of its drug candidate for its expected Phase IIA clinical trial. The drug candidate is expected to be combined with its novel intranasal device, for the treatment of mild Traumatic Brain Injury, aka concussion. Oragenics’ lead drug candidate, ONP-002, is a new chemical entity, or NCE, designed to target the brain through self-propelled powdered delivery into the nasal cavity and onward to the brain. A 40-patient Phase I human study showed ONP-002 to be safe and well-tolerated. Oragenics is currently manufacturing the Active Pharmaceutical Ingredient (API) that will then be formulated and spray dried as a nanoparticle powder. Once formulated the powder is loaded into an intranasal device, believed to be novel, that is breath-propelled, which Oragenics believes will improve intranasal binding to the olfactory nerve beds for delivery directly to the brain. This application, believed to be novel, is designed as an acute field deliverable, intended to allow for concussed patients to get treatment in the early stages when the pathological cascade is most intense. Phase II patients will be recruited between the ages of 18-55 in the acute phase following concussion. Intranasal delivery of ONP-002 as a nanoparticle has been shown to enhance brain exposure and metabolism in animals. “Preclinical intranasal targeting of the brain has been shown to improve outcomes in animals and safety margin following concussion. We are excited to be finishing up ONP-002 manufacturing and formulation work needed for our Phase II study which is on the horizon,” commented Michael Redmond, president of Oragenics.