Oragenics, Inc. is advancing its lead drug candidate, ONP-002, for the treatment of mild traumatic brain injury (mTBI), commonly known as concussion. The company is gearing up for Phase II clinical trials in Australia, with the first patient expected to be dosed by the end of Q1 2025 or early Q2 2025. These trials aim to evaluate the efficacy and safety of ONP-002, delivered via an improved intranasal device, in patients with concussions.
ONP-002 Formulation and Clinical Trial Preparations
Following a capital raise in September 2024, Oragenics has focused on enhancing the formulation of ONP-002 and its intranasal delivery system. The company has completed a spray-dry campaign to ensure an adequate supply of drug-device units for the upcoming trials. These units have been validated and are ready for shipment to clinical trial sites in Australia. Agreements with clinical research organizations (CROs) and hospital partners in Australia are nearing finalization.
Intranasal Delivery Device for Altered Consciousness
Oragenics has also completed prototyping for an automated intranasal device designed for patients with altered states of consciousness, potentially improving drug delivery in acute concussion scenarios. The company is also focused on protecting its intellectual property related to these advancements.
Regulatory and Clinical Milestones
Oragenics reports that regulatory milestones, including the closure of Phase I clinical trials and the submission of data for investigational new drug (IND) and investigator's brochure (IB) approvals, are on track. The company anticipates submitting the IB package for the Australian Phase II clinical trials by Q1 2025 and the IND package for Phase IIb clinical trials in the United States by Q3 2025.
Leadership Transition
Janet Huffman has been appointed as interim CEO of Oragenics, bringing extensive experience in capital raising, mergers and acquisitions, and financial planning. Prior to joining Oragenics, Huffman served as CFO for TRxADE HEALTH, Inc. The Oragenics Board of Directors has expressed confidence in Huffman's ability to lead the company through its next phase of growth.
"I am honored to take on this role, and am deeply committed to Oragenics' mission of addressing unmet medical needs through innovation," said Ms. Huffman. "As we work to advance ONP-002 and prepare for the next phase of clinical development, I look forward to collaborating with our dedicated team and stakeholders to build on the momentum we've created."
Financial Strategy and Future Outlook
Oragenics has strategically allocated resources from its recent capital raise towards drug and device formulation improvements, device prototyping, and Phase II clinical trial preparations. The company is also investing in the protection and acquisition of patents related to these advancements.
Looking ahead, Oragenics is focused on formalizing strategic partnerships in Australia and dosing the first patient in the Phase II clinical trial by early Q2 2025. Huffman expressed optimism about the company's direction and the potential impact of ONP-002 on patient outcomes and shareholder value.
