Oragenics, Inc. Announces Health and Disability Ethics Committee Submission for Phase IIa Concussion Trial
Oragenics (NYSE American: OGEN) has submitted a clinical trial protocol to New Zealand's Health and Disability Ethics Committee (HDEC) for its Phase IIa concussion trial. The study will evaluate ONP-002, the company's proprietary neurosteroid therapy for mild traumatic brain injury (mTBI).
The trial is set to be conducted at Christchurch Hospital, New Zealand's largest tertiary teaching and research hospital on the South Island, which treats over 83,000 emergency patients annually. Upon approval, Oragenics plans to expand patient enrollment across Australia and New Zealand.
ONP-002 is administered intranasally and has shown promising results in preclinical models, reducing inflammation, oxidative stress, and brain swelling associated with concussion. The therapy has already demonstrated safety and tolerability in Phase I trials with healthy volunteers. Notably, this represents the first novel chemical drug entity tested for efficacy in concussion treatment, addressing an unmet medical need with no current pharmaceutical options available.
Oragenics (NYSE American: OGEN) ha presentato un protocollo di sperimentazione clinica al Comitato Etico per la Salute e la Disabilità della Nuova Zelanda (HDEC) per il suo studio di fase IIa sui traumi cranici. Lo studio valuterà ONP-002, la terapia neurosteroidea proprietaria dell'azienda per lesioni cerebrali traumatiche lievi (mTBI).
La sperimentazione si svolgerà presso l'Ospedale di Christchurch, il più grande ospedale universitario e di ricerca della Nuova Zelanda, situato nell'Isola del Sud, che tratta oltre 83.000 pazienti di emergenza ogni anno. Una volta approvato, Oragenics prevede di ampliare l'arruolamento dei pazienti in Australia e Nuova Zelanda.
ONP-002 viene somministrato per via intranasale e ha mostrato risultati promettenti in modelli preclinici, riducendo l'infiammazione, lo stress ossidativo e il gonfiore cerebrale associati al trauma cranico. La terapia ha già dimostrato sicurezza e tollerabilità nei trial di fase I con volontari sani. È importante notare che questo rappresenta il primo nuovo ente chimico farmaceutico testato per l'efficacia nel trattamento dei traumi cranici, rispondendo a un'esigenza medica non soddisfatta senza opzioni farmaceutiche disponibili attualmente.
Oragenics (NYSE American: OGEN) ha presentado un protocolo de ensayo clínico al Comité de Ética en Salud y Discapacidad de Nueva Zelanda (HDEC) para su ensayo de fase IIa sobre conmociones cerebrales. El estudio evaluará ONP-002, la terapia neuroesteroidea patentada de la compañía para lesiones cerebrales traumáticas leves (mTBI).
El ensayo se llevará a cabo en el Hospital de Christchurch, el hospital universitario y de investigación más grande de Nueva Zelanda, ubicado en la Isla Sur, que atiende a más de 83,000 pacientes de emergencia cada año. Una vez aprobado, Oragenics planea ampliar la inscripción de pacientes en Australia y Nueva Zelanda.
ONP-002 se administra por vía intranasal y ha mostrado resultados prometedores en modelos preclínicos, reduciendo la inflamación, el estrés oxidativo y la hinchazón cerebral asociada con la conmoción. La terapia ya ha demostrado seguridad y tolerabilidad en ensayos de fase I con voluntarios sanos. Cabe destacar que este representa el primer nuevo fármaco químico probado por su eficacia en el tratamiento de conmociones cerebrales, abordando una necesidad médica no satisfecha sin opciones farmacéuticas disponibles actualmente.
오라제닉스 (NYSE American: OGEN)는 뉴질랜드 건강 및 장애 윤리 위원회(HDEC)에 2상 뇌진탕 임상 시험 프로토콜을 제출했습니다. 이 연구는 경미한 외상성 뇌손상(mTBI)에 대한 회사의 독점 신경스테로이드 치료제인 ONP-002를 평가할 것입니다.
임상 시험은 뉴질랜드 남섬에 위치한 크라이스트처치 병원에서 진행될 예정이며, 이 병원은 매년 83,000명 이상의 응급환자를 치료하는 뉴질랜드 최대의 대학병원입니다. 승인이 이루어지면 오라제닉스는 호주와 뉴질랜드에서 환자 등록을 확대할 계획입니다.
ONP-002는 비강 내로 투여되며, 뇌진탕과 관련된 염증, 산화 스트레스 및 뇌 부기를 줄이는 데 있어 전임상 모델에서 유망한 결과를 보여주었습니다. 이 치료법은 건강한 자원봉사자를 대상으로 한 1상 시험에서 안전성과 내약성을 이미 입증했습니다. 특히, 이는 뇌진탕 치료의 효능을 시험한 최초의 새로운 화학 약물로, 현재 이용 가능한 제약 옵션이 없는 의료적 요구를 해결하고 있습니다.
Oragenics (NYSE American: OGEN) a soumis un protocole d'essai clinique au Comité d'éthique de la santé et du handicap de Nouvelle-Zélande (HDEC) pour son essai de phase IIa sur les commotions cérébrales. L'étude évaluera ONP-002, la thérapie neurostéroïde propriétaire de l'entreprise pour les lésions cérébrales traumatiques légères (mTBI).
L'essai sera réalisé à l'Hôpital de Christchurch, le plus grand hôpital universitaire et de recherche de Nouvelle-Zélande, situé sur l'île du Sud, qui traite plus de 83 000 patients d'urgence chaque année. Une fois approuvé, Oragenics prévoit d'élargir l'inscription des patients en Australie et en Nouvelle-Zélande.
ONP-002 est administré par voie intranasale et a montré des résultats prometteurs dans des modèles précliniques, réduisant l'inflammation, le stress oxydatif et le gonflement cérébral associé à la commotion. La thérapie a déjà démontré sa sécurité et sa tolérabilité lors d'essais de phase I avec des volontaires en bonne santé. Il convient de noter qu'il s'agit du premier nouvel agent chimique testé pour son efficacité dans le traitement des commotions cérébrales, répondant à un besoin médical non satisfait sans options pharmaceutiques actuellement disponibles.
Oragenics (NYSE American: OGEN) hat ein klinisches Studienprotokoll beim Health and Disability Ethics Committee (HDEC) Neuseelands für seine Phase-IIa-Studie zu Gehirnerschütterungen eingereicht. Die Studie wird ONP-002 bewerten, die firmeneigene Neurosteroidtherapie für leichte traumatische Hirnverletzungen (mTBI).
Die Studie soll im Christchurch Hospital, dem größten Lehr- und Forschungskrankenhaus Neuseelands auf der Südinsel, durchgeführt werden, das jährlich über 83.000 Notfallpatienten behandelt. Nach Genehmigung plant Oragenics, die Patienteneinschreibung in Australien und Neuseeland auszuweiten.
ONP-002 wird intranasal verabreicht und hat in präklinischen Modellen vielversprechende Ergebnisse gezeigt, indem es Entzündungen, oxidativen Stress und Schwellungen des Gehirns, die mit Gehirnerschütterungen verbunden sind, reduziert. Die Therapie hat bereits in Phase-I-Studien mit gesunden Freiwilligen Sicherheit und Verträglichkeit gezeigt. Bemerkenswert ist, dass dies die erste neuartige chemische Arzneimittelverbindung ist, die auf ihre Wirksamkeit bei der Behandlung von Gehirnerschütterungen getestet wurde und eine unerfüllte medizinische Notwendigkeit anspricht, für die derzeit keine pharmazeutischen Optionen verfügbar sind.
- First-ever novel chemical drug entity tested for concussion treatment, addressing an unmet medical need
- Successful Phase I trial demonstrating safety and tolerability
- Promising preclinical results showing reduction in inflammation and brain swelling
- Strategic expansion of trial locations across Australia and New Zealand
- Still pending regulatory approval for Phase IIa trial
- No guarantee of successful Phase IIa outcomes
- Currently generating no revenue from this product
Insights
Oragenics' submission to New Zealand's Health and Disability Ethics Committee represents meaningful progress in their clinical development pathway for ONP-002. This regulatory filing is a necessary step before they can begin patient enrollment in their Phase IIa concussion trial at Christchurch Hospital.
The expansion to New Zealand complements their existing Australian trial plans, potentially accelerating enrollment timelines by accessing a larger patient pool. Christchurch Hospital's busy emergency department, with 83,000+ annual patients, provides an optimal recruitment environment for concussion cases.
What's particularly significant is that ONP-002 represents a first-in-class approach - it's the first novel chemical entity tested for efficacy in concussion patients, targeting an indication with zero approved pharmaceutical treatments. The intranasal delivery mechanism offers blood-brain barrier advantages for CNS disorders while providing a convenient, non-invasive administration route.
The company has already demonstrated safety and tolerability in Phase I studies, reducing some near-term risk. Their preclinical data showing reductions in inflammation, oxidative stress, and brain swelling provides a reasonable scientific foundation for efficacy expectations.
For a microcap biotech like Oragenics, advancing a clinical-stage neurological asset addressing an unmet medical need represents a potential value inflection point, though investors should recognize substantial hurdles remain including regulatory authorization, successful enrollment, and ultimately demonstrating efficacy in this notoriously challenging indication.
This regulatory submission for ONP-002 addresses a critical therapeutic void in concussion management. Currently, treatment options for mild traumatic brain injury (mTBI) remain to symptom management and rest protocols with no approved pharmaceuticals directly targeting the underlying pathophysiology.
Neurosteroid therapies like ONP-002 show particular promise for concussion by potentially modulating multiple injury mechanisms simultaneously. The neuroinflammation, oxidative stress, and cerebral edema targeted by this compound represent central pathological features driving post-concussion symptoms and potential long-term sequelae.
The intranasal delivery route offers significant advantages for brain-targeting compounds by bypassing the blood-brain barrier through direct nose-to-brain pathways. This approach potentially maximizes CNS concentration while minimizing systemic exposure and side effects—particularly important for acute injury situations.
Christchurch Hospital provides an ideal research environment with its high patient volume and established trauma protocols. The Australasian regional approach also addresses geographical diversity in clinical data, important for potential global regulatory submissions.
While early-stage clinical programs always carry substantial risk, particularly in neurological indications, Oragenics' approach of pursuing an indication with both high prevalence and complete absence of pharmacological alternatives creates a compelling scientific and commercial rationale. The transition from safety data in healthy volunteers to efficacy assessment in actual concussion patients represents the crucial upcoming hurdle in determining ONP-002's potential therapeutic value.
SARASOTA, Fla., April 09, 2025 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a biotechnology company focused on developing novel intranasal therapies for brain-related conditions, today announced that it has submitted a clinical trial protocol for regulatory review to the Health and Disability Ethics Committee (HDEC) in New Zealand.
This submission marks a critical milestone in advancing the Company’s Phase II clinical trial evaluating ONP-002, its proprietary neurosteroid therapy, for the treatment of mild traumatic brain injury (mTBI) or concussion. Pending approval, Oragenics expects to initiate patient enrollment in the region and expand the study’s geographic reach. The trial is expected to be conducted at Christchurch Hospital in New Zealand, the largest tertiary, teaching, and research hospital on the South Island. Christchurch Hospital provides a full range of emergency, acute, elective, and outpatient services, and its Emergency Department is one of the busiest in Australasia, treating more than 83,000 patients annually.
“Submitting our HDEC application is a pivotal step toward advancing ONP-002 and addressing the critical need for effective concussion treatments,” said Janet Huffman, Interim Chief Executive Officer of Oragenics. “With patient enrollment planned in both Australia and New Zealand, including at Christchurch Hospital—one of the region’s leading research institutions—we are hoping to expand our global clinical footprint. We look forward to regulatory feedback and moving closer to bringing this much-needed therapy to patients.”
No pharmaceutical therapy is available for treating concussion, an unmet medical need. These clinical trials mark the first time a novel chemical drug entity has been tested for efficacy in this patient population. ONP-002 is designed for intranasal administration, offering a non-invasive and efficient route for drug delivery to the brain. The therapy has demonstrated promising results in preclinical models, reducing inflammation, oxidative stress, and brain swelling associated with concussion. A Phase I clinical study proved the drug to be safe and well-tolerated in healthy human volunteers.
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.
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FAQ
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