Oragenics Selects Southern Star Research as Clinical Research Organization for ONP-002 Phase IIa Trial
Oragenics (NYSE American: OGEN) has selected Southern Star Research as its Clinical Research Organization (CRO) for the upcoming Phase IIa clinical trial of ONP-002, a drug candidate for concussion treatment. The trial will be a randomized, double-blind, placebo-controlled study evaluating ONP-002 in adults with mild traumatic brain injury (mTBI).
The company has already secured Human Research Ethics Committee (HREC) approval and chosen Australia for the trial due to its streamlined regulatory process, experienced trial sites, and R&D tax incentive benefits. ONP-002 is a proprietary intranasal neurosteroid that has shown promising results in preclinical models, including reduced brain inflammation and improved cognitive function.
Oragenics (NYSE American: OGEN) ha scelto Southern Star Research come Organizzazione per la Ricerca Clinica (CRO) per il prossimo studio clinico di Fase IIa su ONP-002, un candidato farmaco per il trattamento della commozione cerebrale. Lo studio sarà randomizzato, in doppio cieco e controllato con placebo, e valuterà ONP-002 in adulti con trauma cranico lieve (mTBI).
L'azienda ha già ottenuto l'approvazione dal Comitato Etico per la Ricerca sull'Uomo (HREC) e ha scelto l'Australia per lo studio, grazie al suo processo regolatorio semplificato, ai siti di sperimentazione esperti e ai vantaggi fiscali per la ricerca e sviluppo. ONP-002 è un neurosteroide intranasale proprietario che ha mostrato risultati promettenti in modelli preclinici, tra cui la riduzione dell'infiammazione cerebrale e il miglioramento della funzione cognitiva.
Oragenics (NYSE American: OGEN) ha seleccionado a Southern Star Research como su Organización de Investigación Clínica (CRO) para el próximo ensayo clínico de Fase IIa de ONP-002, un candidato farmacéutico para el tratamiento de conmociones cerebrales. El ensayo será aleatorizado, doble ciego y controlado con placebo, evaluando ONP-002 en adultos con lesión cerebral traumática leve (mTBI).
La compañía ya obtuvo la aprobación del Comité de Ética en Investigación Humana (HREC) y eligió Australia para el ensayo debido a su proceso regulatorio simplificado, sitios de ensayo con experiencia y beneficios fiscales para I+D. ONP-002 es un neuroesteroide intranasal patentado que ha mostrado resultados prometedores en modelos preclínicos, incluyendo la reducción de la inflamación cerebral y la mejora de la función cognitiva.
Oragenics (NYSE American: OGEN)는 경증 외상성 뇌손상(mTBI) 성인을 대상으로 ONP-002의 2a상 임상시험을 위해 Southern Star Research를 임상시험기관(CRO)으로 선정했습니다. 이번 시험은 무작위 배정, 이중맹검, 위약 대조 방식으로 진행됩니다.
회사는 이미 인간연구윤리위원회(HREC) 승인을 받았으며, 간소화된 규제 절차, 경험 많은 시험 기관, 연구개발 세제 혜택이 있는 호주를 시험 장소로 선택했습니다. ONP-002는 전임상 모델에서 뇌 염증 감소와 인지 기능 개선 효과를 보인 독자적인 비강 투여 신경스테로이드입니다.
Oragenics (NYSE American : OGEN) a choisi Southern Star Research comme Organisation de Recherche Clinique (CRO) pour le prochain essai clinique de Phase IIa d'ONP-002, un candidat médicament pour le traitement de la commotion cérébrale. L'essai sera randomisé, en double aveugle et contrôlé par placebo, évaluant ONP-002 chez des adultes souffrant de traumatisme crânien léger (mTBI).
La société a déjà obtenu l'approbation du Comité d'Éthique de la Recherche Humaine (HREC) et a choisi l'Australie pour l'essai en raison de son processus réglementaire simplifié, de ses sites d'essais expérimentés et de ses avantages fiscaux en matière de R&D. ONP-002 est un neurostéroïde intranasal propriétaire ayant montré des résultats prometteurs dans des modèles précliniques, notamment une réduction de l'inflammation cérébrale et une amélioration des fonctions cognitives.
Oragenics (NYSE American: OGEN) hat Southern Star Research als Clinical Research Organization (CRO) für die bevorstehende Phase IIa-Studie von ONP-002 ausgewählt, einem Wirkstoffkandidaten zur Behandlung von Gehirnerschütterungen. Die Studie wird randomisiert, doppelblind und placebokontrolliert durchgeführt und bewertet ONP-002 bei Erwachsenen mit leichter traumatischer Hirnverletzung (mTBI).
Das Unternehmen hat bereits die Genehmigung des Human Research Ethics Committee (HREC) erhalten und Australien für die Studie gewählt, aufgrund des vereinfachten Zulassungsprozesses, erfahrener Studienzentren und der Steuervorteile für Forschung und Entwicklung. ONP-002 ist ein proprietäres intranasales Neurosteroid, das in präklinischen Modellen vielversprechende Ergebnisse zeigte, darunter reduzierte Gehirnentzündungen und verbesserte kognitive Funktionen.
- Human Research Ethics Committee (HREC) approval already secured
- Preclinical models showed positive results in reducing brain inflammation and improving cognitive function
- Strategic benefits from conducting trials in Australia including R&D tax incentives and streamlined approvals
- Partnership with globally recognized CRO with regional expertise
- Early-stage clinical trial with no guaranteed success
- Additional larger Phase IIb program will be required after this trial
Insights
Oragenics advances ONP-002 concussion program by selecting Southern Star Research as CRO for Phase IIa trial, with patient dosing imminent.
Oragenics' selection of Southern Star Research as CRO for their Phase IIa trial of ONP-002 represents a significant operational milestone in their concussion treatment development program. The company has already secured Human Research Ethics Committee approval—an important regulatory prerequisite—and is now finalizing site selection and investigator agreements.
The decision to conduct the trial in Australia leverages three strategic advantages:
- Streamlined regulatory pathways allowing faster study initiation
- Access to experienced concussion trial sites
- Eligibility for Australia's R&D tax incentive program, improving capital efficiency
ONP-002 is an intranasal neurosteroid with a novel delivery mechanism designed to minimize systemic exposure while maximizing brain penetration. Preclinical data suggests multiple beneficial effects including reduced brain inflammation, improved cognitive function, and enhanced sensory-motor recovery—all critical endpoints for concussion treatment.
The Phase IIa study design as a randomized, double-blind, placebo-controlled trial will provide robust evaluation of safety, tolerability, pharmacokinetics, and early efficacy signals. This positions the company to potentially advance to a larger Phase IIb program if positive data emerges.
With no FDA-approved treatments for concussion/mild traumatic brain injury currently available, Oragenics is addressing a significant unmet medical need in a condition affecting millions annually. Patient enrollment is expected to begin shortly, representing the transition from preparatory to active clinical investigation.
Strategic CRO Partnership Supports Operational Readiness and Initiation of Upcoming Concussion Study
SARASOTA, Fla., July 31, 2025 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a clinical-stage biotechnology company pioneering intranasal drug delivery for neurological conditions, today announced the selection of Southern Star Research as its Clinical Research Organization (CRO) for the upcoming Phase IIa clinical trial of ONP-002, the company’s lead drug candidate for concussion.
Southern Star Research is a globally recognized, full-service CRO with a proven track record in delivering early-phase trials across Australia and Asia-Pacific. Their deep operational expertise, regulatory knowledge, and hands-on site management capabilities will support the execution of Oragenics’ randomized, double-blind, placebo-controlled Phase IIa study evaluating ONP-002 in adults with mild traumatic brain injury (mTBI).
“Partnering with Southern Star Research ensures we are leveraging experienced, regionally specialized clinical leadership to advance ONP-002,” said Dr James Kelly, Chief Medical Officer of Oragenics. “They bring operational rigor, startup speed, and therapeutic area experience needed to move this important program forward efficiently and cost-effectively.”
Southern Star Research Founder & Managing Director, Dr. David Lloyd commented, “We are pleased to be partnering with Oragenics on the development of ONP-002. The Phase IIa study of self-administered Intranasal ONP-002 in subjects with mild Traumatic Brain Injury is a significant milestone for Oragenics and we are excited to manage the ONP-002 program here in Australia, paving the way for a larger Phase IIb program.”
With Human Research Ethics Committee (HREC) approval already secured, Oragenics is working closely with Southern Star to complete site selection, finalize investigator agreements, and prepare for trial site initiation. Patient enrollment and dosing are expected to begin shortly.
The company’s strategic decision to conduct the study in Australia reflects several advantages:
- Access to streamlined regulatory and ethics approval processes
- Availability of experienced concussion trial sites
- Eligibility for Australia’s R&D tax incentive program, enhancing cost-efficiency
ONP-002 is a proprietary intranasal neurosteroid with a novel delivery mechanism designed to enhance drug delivery to the brain while minimizing systemic exposure. In preclinical models, ONP-002 demonstrated reduced brain inflammation, improved memory and cognition, and recovery of sensory-motor function.
The Phase IIa trial will evaluate the safety, tolerability, pharmacokinetics (PK), and early pharmacodynamic (PD) effects of ONP-002 in adults with mTBI.
Janet Huffman, Chief Executive Officer of Oragenics, further commented: “This marks a pivotal step toward initiating our Phase IIa clinical trial, and we remain committed to rapidly advancing this program to address the significant unmet need in concussion treatment. With our study infrastructure nearly in place, we are excited to begin patient enrollment and move one step closer to delivering a therapeutic option for those impacted by mild traumatic brain injury.”
About Oragenics, Inc.
Oragenics is focused on developing novel intranasal therapeutics to address unmet needs in neurology. The company’s lead candidate, ONP-002, is in clinical development for the treatment of concussion. Oragenics is headquartered in Sarasota, Florida. For more information, visit www.oragenics.com.
About Southern Star Research
Southern Star Research is a privately-owned, full-service CRO headquartered in Sydney, Australia. The company specializes in early-phase clinical development across a range of therapeutic areas, supporting sponsors with local regulatory expertise, high-performing sites, and agile clinical operations.
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Investor Contact:
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FAQ
What is the purpose of Oragenics' (OGEN) Phase IIa trial for ONP-002?
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How is ONP-002 administered to patients?
