Oragenics, Inc. Announces Approval to Initiate Phase II Concussion Drug Trial in Australia
Oragenics (NYSE: OGEN) has received approval from Australia's Human Research Ethics Committee (HREC) to begin a Phase II clinical trial for ONP-002, its intranasal neuroprotective therapy for treating concussions (mild traumatic brain injury). Patient enrollment could start as early as Q2 2025, with trials conducted in level 1 trauma emergency departments across Australia and New Zealand.
ONP-002 is administered intranasally and has shown promising results in preclinical models, demonstrating ability to reduce inflammation, oxidative stress, and brain swelling associated with concussion. The drug has already completed Phase I trials, proving to be safe and well-tolerated.
Oragenics (NYSE: OGEN) ha ottenuto l'approvazione dal Comitato Etico per la Ricerca Umana australiano (HREC) per avviare una fase II di sperimentazione clinica per ONP-002, la sua terapia neuroprotettiva intranasale per il trattamento delle commozioni cerebrali (traumi cranici lievi). L'arruolamento dei pazienti potrebbe iniziare già nel secondo trimestre del 2025, con le sperimentazioni che si svolgeranno nei reparti di emergenza di trauma di livello 1 in Australia e Nuova Zelanda.
ONP-002 viene somministrato per via intranasale e ha mostrato risultati promettenti nei modelli preclinici, dimostrando la capacità di ridurre l'infiammazione, lo stress ossidativo e il gonfiore cerebrale associati alla commozione cerebrale. Il farmaco ha già completato la fase I della sperimentazione, risultando sicuro e ben tollerato.
Oragenics (NYSE: OGEN) ha recibido la aprobación del Comité de Ética en Investigación Humana de Australia (HREC) para iniciar un ensayo clínico de fase II para ONP-002, su terapia neuroprotectora intranasal para el tratamiento de conmociones cerebrales (lesiones cerebrales traumáticas leves). La inscripción de pacientes podría comenzar tan pronto como en el segundo trimestre de 2025, con ensayos realizados en departamentos de emergencia de trauma de nivel 1 en Australia y Nueva Zelanda.
ONP-002 se administra por vía intranasal y ha mostrado resultados prometedores en modelos preclínicos, demostrando su capacidad para reducir la inflamación, el estrés oxidativo y la hinchazón cerebral asociada con la conmoción. El medicamento ya completó los ensayos de fase I, demostrando ser seguro y bien tolerado.
Oragenics (NYSE: OGEN)는 호주 인체 연구 윤리 위원회(HREC)로부터 경증 외상성 뇌손상(뇌진탕) 치료를 위한 비강 내 신경 보호 치료제 ONP-002의 2상 임상시험 시작 승인을 받았습니다. 환자 등록은 2025년 2분기부터 시작될 수 있으며, 호주와 뉴질랜드의 1급 외상 응급실에서 시험이 진행될 예정입니다.
ONP-002는 비강 내 투여되며, 전임상 모델에서 염증, 산화 스트레스 및 뇌 부종을 감소시키는 유망한 효과를 보였습니다. 이 약물은 이미 1상 시험을 완료하여 안전하고 내약성이 우수함을 입증했습니다.
Oragenics (NYSE : OGEN) a obtenu l'approbation du Comité d'éthique de la recherche humaine d'Australie (HREC) pour lancer un essai clinique de phase II pour ONP-002, sa thérapie neuroprotectrice intranasale destinée au traitement des commotions cérébrales (lésions cérébrales traumatiques légères). Le recrutement des patients pourrait débuter dès le deuxième trimestre 2025, avec des essais menés dans les services d'urgence de traumatologie de niveau 1 en Australie et en Nouvelle-Zélande.
ONP-002 est administré par voie intranasale et a montré des résultats prometteurs dans des modèles précliniques, démontrant sa capacité à réduire l'inflammation, le stress oxydatif et l'œdème cérébral associés à la commotion. Le médicament a déjà achevé les essais de phase I, prouvant sa sécurité et sa bonne tolérance.
Oragenics (NYSE: OGEN) hat die Genehmigung des australischen Human Research Ethics Committee (HREC) erhalten, eine Phase-II-Studie für ONP-002 zu starten, eine intranasale neuroprotektive Therapie zur Behandlung von Gehirnerschütterungen (leichte traumatische Hirnverletzungen). Die Patientenaufnahme könnte bereits im zweiten Quartal 2025 beginnen, mit Studien, die in Level-1-Trauma-Notaufnahmen in Australien und Neuseeland durchgeführt werden.
ONP-002 wird intranasal verabreicht und hat in präklinischen Modellen vielversprechende Ergebnisse gezeigt, indem es Entzündungen, oxidativen Stress und Hirnschwellungen, die mit Gehirnerschütterungen einhergehen, reduziert. Das Medikament hat bereits Phase-I-Studien abgeschlossen und erwies sich als sicher und gut verträglich.
- HREC approval received to initiate Phase II clinical trial in Australia
- Phase I trial already completed successfully showing safety and tolerability
- Preclinical data demonstrated positive effects in reducing inflammation, oxidative stress, and brain swelling
- Geographic expansion of trial sites to include Australia and New Zealand
- Non-invasive intranasal administration method offering efficient drug delivery
- None.
Insights
Oragenics' Phase II trial approval in Australia marks significant advancement for their concussion drug ONP-002, showing positive clinical development momentum.
Oragenics has reached a critical regulatory milestone with the Human Research Ethics Committee (HREC) approval to commence Phase II trials for ONP-002 in Australia. This approval significantly expands their clinical development footprint internationally and accelerates their development timeline, with patient enrollment potentially beginning in Q2 2025.
The focus on mild traumatic brain injury (mTBI) addresses a substantial unmet medical need. Currently, concussion management is largely limited to observation and symptom management rather than targeted pharmacological intervention. ONP-002 could potentially fill this therapeutic gap through its intranasal delivery mechanism, which allows direct drug delivery to the brain while bypassing the blood-brain barrier - a significant advantage for CNS therapeutics.
The preclinical data showing ONP-002's ability to reduce inflammation, oxidative stress, and brain swelling targets the primary pathophysiological mechanisms of concussion. These mechanisms are responsible for both immediate symptoms and potential long-term neurological sequelae. The successful completion of Phase I trials demonstrating safety and tolerability removes a critical early hurdle in drug development.
The trial's planned implementation in level 1 trauma emergency departments is strategically sound, as this setting captures the acute phase of concussion when neuroprotective intervention would theoretically be most effective. This approach aligns with the therapeutic window concept in neurological injury, where earlier intervention typically yields better outcomes.
SARASOTA, Fla., May 13, 2025 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a biotechnology company focused on developing novel intranasal therapies for brain-related disorders, today announced that it has received approval from the Human Research Ethics Committee (HREC) in Australia to initiate its Phase II clinical trial evaluating ONP-002, the Company's proprietary neuroprotective therapy, for the treatment of mild traumatic brain injury (mTBI), aka concussion.
This approval marks a significant milestone in expanding Oragenics’ clinical development efforts internationally. With this clearance, Oragenics can initiate clinical trials in Australia and could begin patient enrollment as early as the second quarter of 2025. Once the Company is prepared to commence enrollment, patient enrollment and treatment administration is expected to occur in level 1 trauma emergency departments where concussed patients are often seen following motor vehicle accidents, falls, and contact sports
"Receiving HREC approval in Australia brings us one step closer to offering a much-needed therapeutic option for patients suffering from concussions," said Janet Huffman, Chief Executive Officer of Oragenics. "With enrollment sites considered in both Australia and New Zealand, we are significantly expanding the geographic footprint of our ONP-002 program as we move this critical drug trial forward.”
ONP-002 is designed for intranasal administration, offering a non-invasive and efficient route for drug delivery to the brain. In preclinical models, ONP-002 has demonstrated the ability to reduce inflammation, oxidative stress, and brain swelling associated with concussion. A Phase I clinical trial showed ONP-002 to be safe and well-tolerated. ONP-002 is being positioned as a promising potential acute therapy for this widespread condition.
Investor Contact
Rich Cockrell
866.889.1972
ogen@cg.capital
About Oragenics, Inc.
Oragenics is a biotechnology company focused on developing intranasal therapeutics for neurological disorders, including its lead candidate, ONP-002, for the treatment of mild traumatic brain injury (mTBI) or concussion. The Company is also advancing proprietary powder formulations and intranasal delivery technology to enhance drug administration. For more information, visit www.oragenics.com.
Forward-Looking Statements
This communication contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s beliefs and assumptions and information currently available. The words “believe,” “expect,” “anticipate,” “intend,” “estimate,” “project” and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to, those described in our Form 10-K and other filings with the U.S. Securities and Exchange Commission. All information set forth in this press release is as of the date hereof. You should consider these factors in evaluating the forward-looking statements included in this press release and not place undue reliance on such statements. We do not assume any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, circumstances should change, except as otherwise required by law.
FAQ
What is the status of Oragenics (OGEN) ONP-002 clinical trials for concussion treatment?
How is Oragenics' ONP-002 concussion drug administered to patients?
What results has Oragenics' ONP-002 shown in preclinical trials?
Where will Oragenics conduct its Phase II trials for ONP-002?
What conditions is Oragenics' ONP-002 designed to treat?
