Sarasota, Fla. — February 3, 2026 — Leads & Copy — Oragenics, Inc. (NYSE American: OGEN), a clinical-stage biotechnology company, has engaged DUCK FLATS Pharma as its U.S. Investigational New Drug (IND) readiness and regulatory execution partner to support FDA preparation and clinical trial design for its novel intranasal concussion therapy.
The engagement aims to align Oragenics’ upcoming Phase 2a clinical trial in Australia with its U.S regulatory strategy. The company is focused on developing intranasal therapeutics for neurological disorders.
Oragenics’ CEO Janet Huffman said the company values the collaboration with DUCK FLATS Pharma as it advances its IND strategy for ONP-002 and prepares for future U.S. clinical development. Huffman added that by emphasizing regulatory rigor and early preparation, the company aims to ensure trial integrity and reduce risk across the U.S. development pathway.
DUCK FLATS Pharma’s leadership team has contributed to the development and approval of approximately 40 drug programs, including intranasal therapies such as Narcan® and neffy®, through regulatory submission strategies, nonclinical and clinical development, and FDA engagement. Oragenics believes their experience with market-leading drug programs will inform Oragenics’ regulatory and clinical development strategy as it advances its lead concussion therapy toward a U.S. Phase 2b trial and later-stage development.
DUCK FLATS Pharma supports companies through a senior leadership-led engagement model, integrating nonclinical, clinical, and regulatory strategies. The team has served as project lead on more than 60 FDA-approved New Drug Applications and managed over 400 regulatory documents across development programs. Team members have served as consultants on Advisory Committee initiatives for the FDA and other global regulatory authorities.
The firm’s Phase 1 and 2 clinical study services include protocol development, case processing, risk management, biomedical literature and medical monitoring. The company also has expertise in nonclinical development to support the clinical indication.
Luana R. C. Pesco Koplowitz, M.D., Ph.D., Founder, President and Chief Scientific Officer of DUCK FLATS Pharma said it is rewarding to engage with Oragenics on overall development strategy for its novel treatment for concussion and mild-traumatic brain injury, a category with no approved therapies for a vast and urgent unmet medical need.
Traumatic brain injuries affect more Americans each year than stroke, Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, and ALS combined, based on aggregated U.S. incidence estimates. Currently, there are no FDA-approved therapies to treat the underlying injury.
The global concussion market is projected to reach over $9 billion by 2027. As an investigational neuroprotective intranasal drug, ONP-002 if approved by the FDA would join a nasal drug delivery market expected to reach $125+ billion by 2030.
Oragenics is developing brain-targeted therapeutics through proprietary intranasal delivery technology. The Company’s lead candidate, ONP-002, is being advanced as a potential first-in-class treatment for concussion and mild traumatic brain injury. Oragenics is progressing ONP-002 through Phase 2a clinical trials in Australia, with U.S. Phase IIb trials planned to follow. The Company’s intranasal delivery platform has potential applications across multiple neurological conditions, including Parkinson’s disease, Alzheimer’s disease, PTSD, and anxiety disorders.
Oragenics is committed to developing innovative therapies that address significant unmet medical needs in neurological care.
Source: Oragenics, Inc.
