Oragenics, Inc. Submits Investigator’s Brochure for Phase II Clinical Trial of ONP-002 in Mild Traumatic Brain Injury (mTBI)
Oragenics (NYSE American: OGEN) has submitted an Investigator's Brochure (IB) application for its Phase II clinical trial of ONP-002 in Australia. The trial will evaluate this novel intranasal neurosteroid as a potential treatment for mild traumatic brain injury (mTBI), or concussion.
ONP-002 has shown promising preclinical results in reducing inflammation, oxidative stress, and brain swelling. A previous Phase I study confirmed safety and tolerability at multiple intranasal doses. The Phase II study will assess acute intranasal administration in mTBI patients through cognitive testing, visual motor testing, and biomarker analysis.
The IB submission provides investigators with comprehensive clinical and non-clinical data, including safety, pharmacokinetics, and pharmacodynamics information. Currently, there are no FDA-approved drug therapies for concussions, representing a significant unmet medical need. The company expects to receive final regulatory approvals and initiate the clinical trial in the coming weeks.
Oragenics (NYSE American: OGEN) ha presentato una domanda per il Brochure dell'Investigatore (IB) per il suo studio clinico di Fase II riguardante ONP-002 in Australia. Lo studio valuterà questo nuovo neurosteroide intranasale come potenziale trattamento per il trauma cranico lieve (mTBI), o commozione cerebrale.
ONP-002 ha mostrato risultati preclinici promettenti nella riduzione dell'infiammazione, dello stress ossidativo e del gonfiore cerebrale. Un precedente studio di Fase I ha confermato la sicurezza e la tollerabilità a diverse dosi intranasali. Lo studio di Fase II valuterà l'amministrazione intranasale acuta nei pazienti con mTBI attraverso test cognitivi, test visuo-motori e analisi di biomarcatori.
La presentazione dell'IB fornisce agli investigatori dati clinici e non clinici completi, inclusi informazioni su sicurezza, farmacocinetica e farmacodinamica. Attualmente, non esistono terapie farmacologiche approvate dalla FDA per le commozioni cerebrali, rappresentando un significativo bisogno medico insoddisfatto. L'azienda si aspetta di ricevere le approvazioni regolatorie finali e di avviare lo studio clinico nelle prossime settimane.
Oragenics (NYSE American: OGEN) ha presentado una solicitud para el Folletín del Investigador (IB) para su ensayo clínico de Fase II de ONP-002 en Australia. El ensayo evaluará este nuevo neuroesteroide intranasal como un posible tratamiento para la lesión cerebral traumática leve (mTBI), o conmoción cerebral.
ONP-002 ha mostrado resultados preclínicos prometedores en la reducción de la inflamación, el estrés oxidativo y la hinchazón cerebral. Un estudio previo de Fase I confirmó la seguridad y tolerabilidad a múltiples dosis intranasales. El estudio de Fase II evaluará la administración intranasal aguda en pacientes con mTBI a través de pruebas cognitivas, pruebas visuo-motoras y análisis de biomarcadores.
La presentación del IB proporciona a los investigadores datos clínicos y no clínicos completos, incluyendo información sobre seguridad, farmacocinética y farmacodinámica. Actualmente, no hay terapias farmacológicas aprobadas por la FDA para las conmociones cerebrales, lo que representa una necesidad médica significativa no satisfecha. La empresa espera recibir las aprobaciones regulatorias finales e iniciar el ensayo clínico en las próximas semanas.
오라제닉스 (NYSE American: OGEN)는 호주에서 ONP-002의 2상 임상 시험을 위한 임상 연구자 브로셔(IB) 신청서를 제출했습니다. 이 시험은 경미한 외상성 뇌손상(mTBI) 또는 뇌진탕에 대한 잠재적 치료제로서 이 새로운 비강 내 신경스테로이드를 평가할 것입니다.
ONP-002는 염증, 산화 스트레스 및 뇌 부종을 줄이는 데 있어 유망한 전임상 결과를 보여주었습니다. 이전의 1상 연구에서는 여러 비강 내 용량에서 안전성과 내약성을 확인했습니다. 2상 연구는 인지 테스트, 시각 운동 테스트 및 바이오마커 분석을 통해 mTBI 환자에서 급성 비강 내 투여를 평가할 것입니다.
IB 제출은 연구자들에게 안전성, 약동학 및 약리학적 정보 등 포괄적인 임상 및 비임상 데이터를 제공합니다. 현재 뇌진탕에 대해 FDA 승인 약물이 없으며, 이는 중요한 의료적 요구를 나타냅니다. 회사는 최종 규제 승인을 받고 향후 몇 주 내에 임상 시험을 시작할 것으로 기대하고 있습니다.
Oragenics (NYSE American: OGEN) a soumis une demande de Brochure de l'Investigateur (IB) pour son essai clinique de Phase II concernant ONP-002 en Australie. L'essai évaluera ce nouveau neurostéroïde intranasal comme traitement potentiel pour les lésions cérébrales traumatiques légères (mTBI), ou commotion cérébrale.
ONP-002 a montré des résultats précliniques prometteurs dans la réduction de l'inflammation, du stress oxydatif et du gonflement cérébral. Une étude de Phase I précédente a confirmé la sécurité et la tolérabilité à plusieurs doses intranasales. L'étude de Phase II évaluera l'administration intranasale aiguë chez des patients mTBI à travers des tests cognitifs, des tests visuo-moteurs et une analyse de biomarqueurs.
La soumission de l'IB fournit aux chercheurs des données cliniques et non cliniques complètes, y compris des informations sur la sécurité, la pharmacocinétique et la pharmacodynamie. Actuellement, il n'existe aucune thérapie médicamenteuse approuvée par la FDA pour les commotions cérébrales, ce qui représente un besoin médical important non satisfait. L'entreprise s'attend à recevoir les approbations réglementaires finales et à initier l'essai clinique dans les semaines à venir.
Oragenics (NYSE American: OGEN) hat einen Antrag auf ein Investigator's Brochure (IB) für seine klinische Phase-II-Studie zu ONP-002 in Australien eingereicht. Die Studie wird dieses neuartige intranasale Neurosteroid als potenzielle Behandlung für leichte traumatische Hirnverletzungen (mTBI) oder Gehirnerschütterungen bewerten.
ONP-002 hat vielversprechende präklinische Ergebnisse bei der Reduzierung von Entzündungen, oxidativem Stress und Hirnschwellung gezeigt. Eine vorherige Phase-I-Studie bestätigte die Sicherheit und Verträglichkeit bei mehreren intranasalen Dosen. Die Phase-II-Studie wird die akute intranasale Verabreichung bei mTBI-Patienten durch kognitive Tests, visuell-motorische Tests und Biomarker-Analysen bewerten.
Die IB-Einreichung liefert den Forschern umfassende klinische und nicht-klinische Daten, einschließlich Informationen zu Sicherheit, Pharmakokinetik und Pharmakodynamik. Derzeit gibt es keine von der FDA zugelassenen Arzneimitteltherapien für Gehirnerschütterungen, was einen erheblichen ungedeckten medizinischen Bedarf darstellt. Das Unternehmen erwartet, in den kommenden Wochen die endgültigen regulatorischen Genehmigungen zu erhalten und die klinische Studie zu starten.
- Phase II trial preparation advances with IB submission
- Successful Phase I safety and tolerability results
- Promising preclinical data showing reduction in inflammation and brain swelling
- Addresses unmet medical need with no current FDA-approved alternatives
- Regulatory approvals still pending
- Early-stage development with no efficacy proven yet
- Several weeks away from trial initiation
Insights
Oragenics has reached a significant milestone in its clinical development of ONP-002, an intranasal neurosteroid for concussion treatment, with the submission of its Investigator's Brochure (IB) for a Phase II trial in Australia. This step is particularly noteworthy as it follows successful Phase I results demonstrating safety and tolerability, and prepares the company to generate initial proof-of-concept data in actual mild traumatic brain injury (mTBI) patients.
The market opportunity here is substantial given the complete absence of FDA-approved therapies for concussions—a condition affecting millions annually. ONP-002's mechanism targeting inflammation, oxidative stress, and brain swelling addresses the core pathology of concussions, potentially providing the first pharmacological intervention for a condition currently managed only through rest and symptom monitoring.
What elevates this announcement beyond routine pipeline progress is the rapid timeline indicated, with trial initiation expected "in the coming weeks" following regulatory approvals. For a
Investors should recognize this as a concrete advancement in Oragenics' transition from preclinical to clinical-stage development for their lead asset in a therapeutic area with substantial unmet needs.
The submission of an Investigator's Brochure for ONP-002 represents more than procedural progress; it signifies the culmination of a comprehensive data package supporting this novel neurosteroid's mechanism and safety profile. The transition to Phase II testing is particularly significant in the neurological injury space, where many promising compounds face substantial hurdles moving from healthy volunteers to actual patient populations.
ONP-002's intranasal delivery system warrants special attention. This administration route potentially enables rapid drug delivery across the blood-brain barrier—a critical advantage for acute concussion treatment where intervention timing directly influences outcomes. The approach could address the narrow therapeutic window that has challenged previous concussion treatment candidates.
The planned assessments combining cognitive testing, visual motor evaluation, and biomarker analysis represent a sophisticated approach to capturing therapeutic effect. Biomarker validation would provide objective measures of efficacy beyond symptom reporting, potentially strengthening the case for regulatory approval in a field that has struggled with outcome measurement.
The concussion treatment landscape has seen numerous failures, largely due to the heterogeneous nature of brain injuries and challenges in demonstrating meaningful clinical improvements. ONP-002's focus on fundamental injury mechanisms (inflammation, oxidative stress, edema) rather than single pathways increases its probability of demonstrating a measurable treatment effect. However, it's essential to view this development realistically—Phase II success in neurological conditions occurs in approximately
SARASOTA, Fla., March 06, 2025 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a biotechnology company advancing innovative treatments for concussion and brain-related health conditions, today announced the submission of its Investigator’s Brochure (IB) application in preparation for its Phase II clinical trial using ONP-002 in Australia. This milestone represents an important step in advancing ONP-002, a novel intranasal neurosteroid, as a potential treatment for mild traumatic brain injury (mTBI), commonly known as concussion.
ONP-002 has demonstrated promising preclinical results, showing the potential to reduce inflammation, oxidative stress, and brain swelling. A prior Phase I study in healthy adults confirmed the drug’s safety and tolerability at multiple intranasal doses. This upcoming Phase II study aims to establish the feasibility of acute intranasal administration in mTBI patients and generate initial proof-of-concept data through cognitive testing, visual motor testing, and biomarker analysis.
The IB provides investigators with comprehensive clinical and non-clinical data on ONP-002, including its safety, pharmacokinetics, and pharmacodynamics. This document serves as a critical foundation for the study, guiding investigators on protocol requirements such as dosing, intranasal administration protocols, blood biomarker analysis, and safety monitoring. Additionally, the submission enables updates to ClinicalTrials.gov, providing a transparent record of the trial’s details and progress as regulatory approvals advance.
Mild TBI, commonly known as a concussion, is a form of head trauma that temporarily disrupts brain function. Symptoms often include headache, dizziness, confusion, and cognitive impairment. Despite the high incidence of concussions, no FDA-approved drug therapies currently exist, leaving a significant unmet medical need.
“The submission of our Investigator’s Brochure application marks a critical step forward in advancing our clinical program for ONP-002,” said Janet Huffman, Interim CEO of Oragenics. “This submission brings us closer to initiating our clinical trial, and we remain committed to delivering a much-needed therapeutic option for patients suffering from mTBI. We anticipate receiving final regulatory approvals that should allow us to initiate our clinical trial in the coming weeks, and are focused on ensuring a smooth trial launch and look forward to sharing updates as we progress.”
About the Phase II Study
The randomized, double-blind, placebo-controlled Phase II trial is designed to assess the feasibility, safety, tolerability, blood biomarker response, and pharmacokinetics/pharmacodynamics of ONP-002 in adults with mTBI. The study is designed to enroll 40 participants across two treatment arms—20 receiving ONP-002 and 20 receiving a placebo. It is anticipated that participants will receive a total of nine doses over five days, with the first dose administered within 12 hours of injury. Cognitive testing, visual motor testing, and blood biomarker analysis will be used to evaluate the impact of ONP-002 on brain function and recovery.
Investor Contact
Rich Cockrell
404.736.3838
ogen@cg.capital
About Oragenics, Inc.
Oragenics is a development-stage biotechnology company focused on nasal delivery of pharmaceutical medications in neurology and fighting infectious diseases, including drug candidates for treating mild traumatic brain injury (mTBI), also known as concussion, and for treating Niemann Pick Disease Type C (NPC), as well as proprietary powder formulation and an intranasal delivery device. For more information, please visit www.oragenics.com.
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FAQ
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