Oragenics Teams with Avance Clinical for Phase II Concussion Study in Australia

Oragenics, Inc., a trailblazer in the development of novel intranasal pharmaceuticals for neurological conditions, has partnered with Avance Clinical to conduct a Phase II clinical trial in Australia. The focus of this trial is Oragenics' lead drug candidate, ONP-002, which is designed for the treatment of mild Traumatic Brain Injury (TBI), commonly referred to as concussion. This innovative drug is delivered through a specialized intranasal device, optimizing direct delivery to the brain.

Avance Clinical, a prominent Contract Research Organization (CRO) with extensive experience managing clinical trials in Australia, New Zealand, and North America, will oversee the trial. The organization's deep expertise in navigating regulatory requirements from bodies like the Therapeutic Goods Administration, Food and Drug Administration, and European Medicines Agency adds significant value to the trial process.

Recently, Oragenics completed a Phase I clinical trial in Australia with the assistance of Avance Clinical. The results confirmed that ONP-002 is both safe and well-tolerated by participants. Dr. Jorgen Mould, Senior Director of Scientific and Regulatory Services at Avance Clinical, noted the significance of addressing concussion as an unmet medical need. He expressed enthusiasm about collaborating with Oragenics, particularly in a country with a high occurrence of sports-related concussions like Australia.

Michael Redmond, President of Oragenics, emphasized that the success of the Phase I trial was largely due to their collaboration with Avance Clinical. He expressed confidence in Avance Clinical's ability to effectively manage the Phase II trial, which aims to establish new treatment protocols for concussion.

Dr. James Kelly, Neurologist and Chief Medical Officer at Oragenics, highlighted the pivotal role of the Australian medical community in the trial. He praised the country's expertise in diagnosing and treating head injuries, stating that Oragenics is fortunate to conduct this critical research with such skilled professionals.

Concussion remains a prominent unmet medical need globally, with approximately 69 million cases reported annually. Causes include falls, motor vehicle accidents, and contact sports. Concussions are also linked to other neurological disorders such as Alzheimer’s Disease, Parkinson’s Disease, and Chronic Traumatic Encephalopathy (CTE). Post-concussion syndrome, which can result in long-term disability, affects up to 20% of those who suffer concussions.

Oragenics is a biotechnology company focused on developing intranasal delivery systems for treating neurological disorders and infectious diseases. Their pipeline includes treatments for mild Traumatic Brain Injury (TBI) and Niemann Pick Disease Type C (NPC). The company's innovative approach involves proprietary powder formulations and specialized intranasal devices designed to improve drug delivery to the brain.

In summary, Oragenics’ partnership with Avance Clinical to conduct a Phase II clinical trial for ONP-002 in Australia marks a significant step forward in addressing the global issue of concussions. With promising results from the Phase I trial and the expertise of Avance Clinical, this collaboration holds the potential to pave the way for effective new treatments for concussion and related neurological disorders.