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Oragenics and Avance Clinical to lead Phase II trial in concussion



Oragenics has announced a partnership with Avance Clinical to conduct a new clinical trial on its lead drug candidate in the treatment of mild Traumatic Brain Injury (mTBI).

The Phase II trial aims to evaluate Oragenics’ lead drug candidate, ONP-002, for mTBI, commonly known as concussion.

ONP-002, a novel chemical entity (NCE), is delivered through a unique intranasal device and designed to maximise drug delivery directly to the brain.

There are an estimated 69 million concussions annually reported worldwide. Common causes of concussion include falls, motor vehicle accidents, 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 syndrome is linked to long-term disability and occurs in as high as 20 per cent of concussed patients.

Avance Clinical, renowned for its clinical trial management capabilities and quality of service in Australia, New Zealand, and North America, brings over two decades of expertise in navigating the Therapeutic Goods Administration, Food and Drug Administration, and European Medicines Agency regulatory landscapes.

An Oragenics Phase I clinical trial, recently completed in Australia under the management of Avance Clinical, demonstrated that ONP-002 is safe and well-tolerated.

“Concussion remains a significant unmet medical need,” said Dr. Jorgen Mould, Senior Director of Scientific and Regulatory Services at Avance Clinical.

“Oragenics is poised to address this challenge, and we are delighted to be part of the team, especially given Australia’s high incidence of sports-related concussions.”

Michael Redmond, President of Oragenics, added: “Our collaboration with Avance Clinical during the Phase I trial was instrumental, and we are confident in their ability to execute an effective Phase II trial that will pave the way for future treatment protocols for concussion.”

Dr James Kelly, Neurologist and Chief Medical Officer at Oragenics, emphasised the critical role of the Australian medical community, commenting: “Australia has been at the forefront of diagnosing and treating head injuries. We are fortunate to work with such skilled medical professionals in conducting this pivotal research.”