Oragenics, Inc. is making strides in the development of ONP-002, a novel neurosteroid aimed at treating moderate to severe concussions. With successful completion of key pre-clinical studies and recent financial backing, the company is gearing up to initiate Phase II clinical trials, marking a significant step forward in addressing the unmet medical need for effective concussion treatments.
ONP-002 leverages an innovative intranasal delivery system designed for rapid and targeted brain delivery, potentially minimizing systemic side effects. This approach is particularly relevant given that up to 50% of the estimated 69 million annual concussion cases globally go unreported, highlighting the urgent need for accessible and effective therapies.
Advancing Through Pre-Clinical Milestones
In July 2024, ONP-002 demonstrated a strong cardiac safety margin, clearing FDA-required cardiotoxicity tests. Furthermore, genotoxicity studies completed in August 2024 confirmed that the drug does not cause DNA damage, reinforcing its safety profile. These milestones are crucial as they de-risk the program moving into Phase II clinical trials.
An FDA-recognized study using an anatomical model for intranasal drug delivery showed that ONP-002 successfully targets areas inside the nose that are directly linked to the brain. According to Michael Redmond, President of Oragenics, this increases the likelihood of the drug being effective in treating concussion and reduces the likelihood of it being swallowed.
Preparing for Phase II Clinical Trials
Oragenics is collaborating with Avance Clinical and major neurotrauma centers in Australia to finalize Phase II clinical protocols. The trials will evaluate the safety and efficacy of ONP-002 in reducing concussion symptoms and improving functional recovery. A key feature of the Phase II trial is the development of emergency department protocols for patient inclusion, with the goal of administering the first dose within 8 hours of the injury. Efficacy evaluations during this 10-day trial include testing of visual-motor and neurocognitive functional performance while also assessing patient symptoms relative to drug treatment.
The company plans to submit the Australian Regulatory Submission Brochure during the fourth quarter of 2024, a critical step for regulatory approval of the trial in Australia. This submission outlines the clinical trial safety and efficacy protocols, informed consent protocols, and data collection methods.
Financial Support and Future Outlook
Oragenics has secured approximately $6 million in funding through recent financing efforts, including a $4.45 million public offering in September 2024. These funds will support the continued development of ONP-002 and its advancement through Phase II clinical trials.
Oragenics anticipates initiating Phase II clinical trials later this year, starting in Australia and followed by trials in the U.S. These trials will evaluate the effects of ONP-002 on concussion patient symptom reduction and functional recovery.
