Oragenics Completes Drug Manufacturing and Device Filling for Phase IIa Concussion Trial

Oragenics, Inc., a biotechnology firm specializing in intranasal pharmaceuticals for neurological disorders, has announced the completion of its spray-dried formulation for ONP-002, a drug candidate aimed at treating concussions. This development involves preparing the drug in a nasal delivery device, with ONP-002 designed specifically to target the brain through nasal administration.

The company has prepared both placebo and active drug formulations for an upcoming Phase IIa clinical trial to be conducted in Australia. The trial will include 40 patients who have suffered concussions, with participants receiving either the placebo or ONP-002 twice daily for five days following their injury. The study aims to start treatment within eight hours of the injury in the emergency department, with evaluations based on patient-reported outcomes and blood biomarkers.

Michael Redmond, President of Oragenics, highlighted the importance of formulating ONP-002 as a nanoparticle that can be delivered intranasally in powder form. This approach is intended to maximize brain exposure and leverage the anti-inflammatory properties of the drug to mitigate negative outcomes following a concussion. Redmond believes that the combination of the spray-dried powder and the nasal delivery device is ideal for early intervention, potentially halting the progression of concussion-related neuropathology.

Concussions represent a significant unmet medical need, with approximately 69 million cases reported globally each year. Common causes include falls, car accidents, and contact sports. Concussions have also been linked to other neurological conditions such as Alzheimer’s Disease, Parkinson’s Disease, and Chronic Traumatic Encephalopathy (CTE). Post-concussion symptoms can lead to long-term disability, affecting up to 20% of those who suffer from concussions.

Oragenics is a development-stage biotechnology company that focuses on nasal delivery systems for pharmaceuticals aimed at treating infectious diseases and neurological conditions. Their portfolio includes drug candidates for mild traumatic brain injury (mTBI), commonly known as a concussion, and Niemann Pick Disease Type C (NPC), along with proprietary powder formulations and an intranasal delivery device.

In summary, Oragenics is making significant strides in the development of ONP-002, a drug that could become the first pharmaceutical treatment for concussions. The upcoming Phase IIa trial in Australia is a critical step in assessing the efficacy and safety of this novel intranasal drug formulation. With an anticipated start within eight hours of injury and a focus on early intervention, the trial aims to provide new hope for patients suffering from concussions and potentially reduce the incidence of long-term neurological complications.

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