Oragenics, Inc. Updates Shareholders on Concussion Drug Progress and Phase II Trial Preparation
Oragenics, Inc. (NYSE American: OGEN) has provided a corporate update on its progress in developing ONP-002, a first-in-class neurosteroid for treating moderate to severe concussions. Key milestones in 2024 include:
1. Appointment of renowned experts as Chief Medical Officer and Chief Clinical Officer
2. Preparation for Phase II clinical trials
3. Successful completion of cardiotoxicity and genotoxicity tests
4. Partnership with Avance Clinical for trial execution
5. Achievement of temperature stability for ONP-002
6. Completion of spray-dry formulation and intranasal delivery devices
7. Development of a novel nanoparticle formulation increasing drug percentage by 4-fold
8. Successful intranasal casting studies for FDA approval
Oragenics raised over $6 million in 2024 to support ONP-002 development. The company plans to initiate Phase II trials later this year, starting in Australia followed by the U.S., to evaluate safety and efficacy in concussion patients.
Oragenics, Inc. (NYSE American: OGEN) ha fornito un aggiornamento aziendale sui suoi progressi nello sviluppo di ONP-002, un neurosteroide innovativo per il trattamento di commozioni cerebrali da moderate a severe. I principali traguardi previsti per il 2024 includono:
1. Nomina di esperti rinomati come Direttore Medico e Direttore Clinico
2. Preparazione per i trial clinici di Fase II
3. Completamento con successo dei test di cardiotossicità e genotossicità
4. Partnership con Avance Clinical per l'esecuzione dei trial
5. Ottenimento della stabilità termica per ONP-002
6. Completamento della formulazione spray-dry e dei dispositivi per la somministrazione intranasale
7. Sviluppo di una nuova formulazione di nanoparticelle che aumenta la percentuale di farmaco di 4 volte
8. Studio di casting intranasale di successo per l'approvazione da parte della FDA
Oragenics ha raccolto oltre 6 milioni di dollari nel 2024 per sostenere lo sviluppo di ONP-002. L'azienda prevede di avviare i trial di Fase II entro la fine dell'anno, iniziando in Australia e poi negli Stati Uniti, per valutare sicurezza ed efficacia nei pazienti con commozione cerebrale.
Oragenics, Inc. (NYSE American: OGEN) ha proporcionado una actualización corporativa sobre sus progresos en el desarrollo de ONP-002, un neuroesteroide de primera clase para tratar conmociones moderadas a severas. Los hitos clave para 2024 incluyen:
1. Designación de expertos reconocidos como Director Médico y Director Clínico
2. Preparación para ensayos clínicos de Fase II
3. Finalización exitosa de pruebas de cardiotoxicidad y genotoxicidad
4. Asociación con Avance Clinical para la ejecución de ensayos
5. Logro de la estabilidad térmica para ONP-002
6. Completación de formulaciones spray-dry y dispositivos de administración intranasal
7. Desarrollo de una nueva formulación de nanopartículas que incrementa el porcentaje del fármaco en 4 veces
8. Éxito en estudios de casting intranasal para la aprobación de la FDA
Oragenics recaudó más de 6 millones de dólares en 2024 para apoyar el desarrollo de ONP-002. La empresa planea iniciar los ensayos de Fase II más adelante este año, comenzando en Australia y luego en EE.UU., para evaluar la seguridad y eficacia en pacientes con conmociones.
Oragenics, Inc. (NYSE American: OGEN)는 중등도에서 중증의 뇌진탕 치료를 위한 최초의 클래스인 ONP-002의 개발 진행 상황에 대한 기업 업데이트를 제공했습니다. 2024년의 주요 이정표는 다음과 같습니다:
1. 유명 전문가를 최고 의학 책임자 및 최고 임상 책임자로 임명
2. 2단계 임상 시험을 위한 준비
3. 심장 독성 및 유전 독성 테스트의 성공적 완료
4. 실험 실행을 위한 Avance Clinical과의 파트너십
5. ONP-002의 온도 안정성 달성
6. 스프레이-드라이 제형 및 비강 투여 장치의 완성
7. 약물 비율을 4배 증가시킨 새로운 나노 입자 제형 개발
8. FDA 승인을 위한 성공적인 비강 캐스팅 연구
Oragenics는 ONP-002 개발을 지원하기 위해 2024년에 600만 달러 이상을 모금했습니다. 이 회사는 올해 말에 2단계 시험을 시작할 계획이며, 호주에서 시작한 후 미국으로 진행하여 뇌진탕 환자의 안전성과 효능을 평가할 예정입니다.
Oragenics, Inc. (NYSE American: OGEN) a fourni une mise à jour sur les progrès réalisés dans le développement de ONP-002, un neurostéroïde de première classe destiné au traitement des commotions cérébrales modérées à sévères. Les jalons clés de 2024 incluent :
1. Nommer des experts renommés en tant que Directeur Médical et Directeur Clinique
2. Préparation pour les essais cliniques de Phase II
3. Achèvement réussi des tests de cardiotoxicité et de génotoxicité
4. Partenariat avec Avance Clinical pour l'exécution des essais
5. Obtention de la stabilité thermique pour ONP-002
6. Achèvement de la formulation spray-dry et des dispositifs de délivrance intranasale
7. Développement d'une nouvelle formulation de nanoparticules augmentant le pourcentage de médicament par 4
8. Études de casting intranasal réussies pour l'approbation de la FDA
Oragenics a levé plus de 6 millions de dollars en 2024 pour soutenir le développement d'ONP-002. La société prévoit de commencer les essais de Phase II plus tard cette année, d'abord en Australie, puis aux États-Unis, pour évaluer la sécurité et l'efficacité chez les patients souffrant de commotions cérébrales.
Oragenics, Inc. (NYSE American: OGEN) hat ein Unternehmensupdate zu seinen Fortschritten bei der Entwicklung von ONP-002, einem neuartigen Neurosteroid zur Behandlung von mittelschweren bis schweren Gehirnerschütterungen, bereitgestellt. Wichtige Meilensteine im Jahr 2024 umfassen:
1. Ernennung renommierter Experten zum Chief Medical Officer und Chief Clinical Officer
2. Vorbereitung auf Phase-II-Klinische Studien
3. Erfolgreicher Abschluss von Kardiotoxizitäts- und Genotoxizitätstests
4. Partnerschaft mit Avance Clinical zur Durchführung der Studien
5. Erreichung der Temperaturstabilität für ONP-002
6. Abschluss der Spray-Dry-Formulierung und intranasalen Abgabegeräte
7. Entwicklung einer neuartigen Nanopartikel-Formulierung, die den Arzneistoffanteil um das Vierfache erhöht
8. Erfolgreiche intranasale Casting-Studien zur FDA-Zulassung
Oragenics hat 2024 über 6 Millionen US-Dollar gesammelt, um die Entwicklung von ONP-002 zu unterstützen. Das Unternehmen plant, noch in diesem Jahr mit den Phase-II-Studien zu beginnen, die in Australien starten und anschließend in den USA durchgeführt werden, um die Sicherheit und Wirksamkeit bei Patienten mit Gehirnerschütterungen zu bewerten.
- Successful completion of FDA-required cardiotoxicity and genotoxicity tests for ONP-002
- Partnership with Avance Clinical to strengthen Phase II trial execution
- Achievement of temperature stability for ONP-002, eliminating cold-chain storage needs
- Development of a novel nanoparticle formulation increasing drug percentage by 4-fold
- Successful intranasal casting studies demonstrating drug targeting for FDA approval
- Raised over $6 million in 2024 to support ONP-002 development
- Preparation for Phase II clinical trials to evaluate safety and efficacy
- None.
Insights
The update from Oragenics on their concussion drug ONP-002 reveals significant progress in 2024. Key developments include:
- Successful completion of FDA-required cardiotoxicity and genotoxicity tests, demonstrating a strong safety profile
- Achievement of temperature stability, eliminating cold-chain storage requirements
- Development of a novel nanoparticle formulation, potentially increasing drug absorption by 4-fold
- Completion of intranasal casting studies, a critical step for FDA approval
- Preparation for Phase II clinical trials, with plans to initiate later this year
These advancements position ONP-002 as a promising candidate for concussion treatment, addressing a significant unmet medical need. The company's focus on intranasal delivery could offer advantages over traditional methods, potentially leading to faster and more targeted treatment. With over 3 million annual concussion occurrences in the U.S. and no FDA-approved treatments, Oragenics is targeting a substantial market opportunity.
Oragenics' financial position has been strengthened by recent fundraising efforts. The company raised approximately
For a company with a market cap of only
However, investors should note that as a clinical-stage biopharmaceutical company, Oragenics faces inherent risks, including the potential for additional dilutive financing rounds and the uncertainty of clinical trial outcomes. The company's ability to execute its clinical development plan efficiently will be important for long-term value creation.
SARASOTA, Fla., Oct. 09, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a biopharmaceutical company committed to developing novel therapies for neurological disorders, today provided a corporate update reflecting on the company’s progress throughout 2024, including key milestones in the development of ONP-002, its lead candidate for the treatment of concussions.
Company Overview: A Vision for Innovation in Neurology
Oragenics is focused on revolutionizing drug delivery for neurological disorders using innovative intranasal technology. The company’s lead program, ONP-002, is a first-in-class neurosteroid being developed to treat moderate to severe concussions. Intranasal delivery provides numerous advantages over traditional systemic methods, including faster brain delivery, reduced systemic exposure, and a non-invasive approach.
“Our mission is to address significant unmet medical needs by developing cutting-edge therapies,” stated Michael Redmond, President of Oragenics. “There are over 3 million annual concussion occurrences in the U.S. and an estimated 69 million globally, however it is believed that a substantial number, up to
Key Milestones in Concussion Drug Development
Oragenics has made significant advancements in the development of ONP-002 during 2024, including:
Strengthened Clinical Leadership: In 2024, the company appointed two renowned experts—Dr. James “Jim” Kelly as Chief Medical Officer and Dr. William “Frank” Peacock as Chief Clinical Officer—bringing deep expertise in brain health and emergency medicine to oversee the clinical development of ONP-002.
Phase II Clinical Trial Preparation: Building on successful Phase I trials, which demonstrated the safety and tolerability of ONP-002, the company is preparing to initiate Phase II clinical trials, which will evaluate the drug’s efficacy based on patient outcomes.
Successful Cardiotoxicity Testing: In July 2024, ONP-002 demonstrated a strong cardiac safety margin, clearing FDA-required cardiotoxicity tests. These results suggest that the treatment is unlikely to cause cardiac arrhythmias, a crucial milestone that derisks the program as it moves forward into the Phase II clinical trial.
FDA-Required Genotoxicity Studies: In August 2024, ONP-002 successfully completed the necessary studies regarding FDA-required genotoxicity testing, confirming that the drug does not cause DNA damage, further strengthening its safety profile as it advances towards Phase II.
Partnership with Avance Clinical: In May 2024, the company entered into a partnership with Avance Clinical, a leading CRO, strengthening the company’s ability to execute its Phase II trial for ONP-002 and leveraging Avance's expertise in clinical trial management and regulatory pathways.
Temperature Stability Achieved: ONP-002 demonstrated stability across a wide temperature range, eliminating the need for cold-chain storage. This milestone is especially important for field delivery, where concussions frequently occur, such as in sports or military environments.
Spray-Dry Manufacturing and Device Completion: The company completed the spray-dry formulation of ONP-002 and filled intranasal delivery devices needed for upcoming Phase II trial. These ready-to-use devices should enable fast, targeted treatment to patients following a concussion.
Improved Drug Percentage in Final Formulation: A novel nanoparticle spray dried powder formulation was created that should enhance intranasal absorption and increase the amount of ONP-002 per dose by 4-fold. This new formulation is expected to allow for more drug to enter the brain at each treatment increasing the chance for reaching therapeutic levels and patient improvement.
Completion of FDA-Recognized Study for Concussion Drug, ONP-002: Intranasal casting studies are critical for FDA approval of pharmaceuticals delivered via the nasal passage. The study results demonstrated the drug successfully targets the interior nose that is made from cast metal (AINI), making it more likely to reach and treat the brain after a concussion. This model is standard for intranasal drug delivery and is accepted by the FDA as a surrogate for the actual nasal.
Recent Financing and Strategic Growth
In September 2024, Oragenics closed a public offering, raising approximately
“We are grateful for the confidence that our investors have placed in our vision,” added Redmond. “This financing allows us to continue advancing ONP-002, which we believe has the potential to be the first approved drug for concussion treatment.”
Looking Ahead: Key Milestones
Oragenics anticipates several key milestones in the coming months, including:
Initiation of Phase II Clinical Trials: The company plans to begin Phase II trials later this year, initially in Australia, followed by U.S. trials. These trials will evaluate safety and efficacy - evaluating the effects of ONP-002 on concussion patient symptom reduction and functional recovery.
Clinical Site Selection The company is currently working with Avance Clinical, a clinical CRO along with major neurotrauma centers in Australia on Phase II clinical protocols. A key feature of the Phase II trial is to develop emergency department protocols for patient inclusion/exclusion with the goal of having the first dose occur within 8 hours of the injury. Efficacy evaluations during this 10-day trial include testing of visual-motor and neurocognitive functional performance while also assessing patient symptoms relative to drug treatment.
Australian Regulatory Submission Brochure
In preparation for its upcoming Phase II clinical trials, Oragenics plans to submit the Australian Regulatory Submission Brochure during the fourth quarter of 2024. This submission is a critical component for the regulatory approval of the trial in Australia and outlines the clinical trial safety and efficacy protocols, informed consent protocols, and data collection methods.
Continued Development of Intranasal Delivery System: Oragenics’ intranasal system is a breakthrough in brain injury drug delivery, designed to provide rapid, targeted brain delivery with minimal side effects. This system will continue to be a key focus as the company advances ONP-002. This includes the breath-propelled and automated device technologies.
Commitment to Shareholders
Oragenics remains committed to maintaining transparency and open communication with its shareholders. The company will continue to provide updates on its progress as it advances toward key milestones and works to commercialize ONP-002.
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.
Investor Relations:
Rich Cockrell
404.736.3838
achv@cg.capital
FAQ
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