Oragenics, Inc. announced it has developed a new formulation for its novel neurosteroid. Oragenics' lead drug candidate for concussion, ONP-002, is a new chemical entity (NCE) designed to target the brain through delivery into the nasal cavity and toward to the brain. A Phase II study in concussed patients is being planned to assess safety and feasibility while analyzing the drug's effectiveness based on patient blood biomarker profiles and functional outcomes.

Oragenics believes the nasal cavity provides access for Oragenics' novel neurosteroid formulation to enter the brain in minutes. Given the difficulty of getting neurosteroids into solution, unique formulations must be developed to achieve therapeutic levels. Oragenics believes that its recent work has increased the final dose levels significantly while also providing for improved intranasal drug adhesion and, thus, longer absorption times.

Oragenics believes it has successfully completed an improved formulation of ONP-002 that should significantly increase the bioavailability of the intranasal drug formulation. The enhanced drug percentages in this novel formulation have been developed by Oragenics as part of its platform for acute-field delivery of the drug. Oragenics' newly developed intranasal drug formulation is intended to reduce the duration of initial concussion symptoms and prevent long-lasting symptoms that can be debilitating after a concussion.

Other neurological disorders, including Alzheimer's Disease, Parkinson's Disease, and Chronic Traumatic Encephalopathy (CTE), have been linked to concussion. Post-concussion symptomology is linked to long-term disability and occurs in as high as 20% of concussed patients.