Oragenics Improves Intranasal Drug Formulation for Treating Concussed Patients

Oragenics, Inc. recently 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 onward to the brain. A Phase 2 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 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.

“We are thrilled about the recent modifications to our novel intranasal drug formulation. Anything that can be done to drive more chemical protection to the brain during the acute pathological cascade will help reduce negative outcomes in the concussed population,” said Dr. James Kelly, Chief Medical Officer at Oragenics.

Concussion is a serious unmet medical need. There are an estimated 69 million concussions annually reported worldwide. Common causes of concussion include falls, motor vehicle accidents, military incidents, and contact sports. 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.

Oragenics is a development-stage biotechnology company focused on nasal delivery of pharmaceutical medications in neurology and fighting infectious diseases, including drug candidates for treating mild traumatic brain injury (mTBI), also known as concussion, and for treating Niemann Pick Disease Type C (NPC), as well as proprietary intranasal formulations and intranasal devices for delivering the intranasal formulations. For more information, visit www.oragenics.com.