Oragenics, Inc. Announces Concussion Drug Successfully Completes FDA-Required Genotoxicity Study
Oragenics (NYSE American: OGEN) announced that its lead candidate for treating concussion, ONP-002, successfully completed an FDA-required genotoxicity study. The study showed that ONP-002 does not cause DNA damage or increase cancer risk in an animal model, even at high doses. This positive outcome clears a important safety hurdle for ONP-002, a new chemical entity designed for intranasal delivery to the brain.
Key points:
- ONP-002 showed no evidence of genetic mutations or cell cycle disruption
- The study was conducted under Good Laboratory (GLP) conditions
- Oragenics is planning a Phase II clinical trial for ONP-002
- Concussion affects an estimated 69 million people annually worldwide
- The company believes ONP-002 will be safe for concussed patients in the planned trial
Oragenics (NYSE American: OGEN) ha annunciato che il suo candidato principale per il trattamento delle commozioni cerebrali, ONP-002, ha completato con successo uno studio di genotossicità richiesto dalla FDA. Lo studio ha dimostrato che ONP-002 non causa danni al DNA né aumenta il rischio di cancro in un modello animale, anche a dosi elevate. Questo esito positivo supera un'importante barriera di sicurezza per ONP-002, una nuova entità chimica progettata per la somministrazione intranasale al cervello.
Punti chiave:
- ONP-002 non ha mostrato segni di mutazioni genetiche o interruzione del ciclo cellulare
- Lo studio è stato condotto in condizioni di Buona Pratica di Laboratorio (GLP)
- Oragenics sta pianificando uno studio clinico di Fase II per ONP-002
- Si stima che le commozioni cerebrali colpiscano 69 milioni di persone ogni anno a livello globale
- L'azienda crede che ONP-002 sarà sicuro per i pazienti con commozione nell'imminente trial
Oragenics (NYSE American: OGEN) anunció que su candidato principal para el tratamiento de la conmoción cerebral, ONP-002, completó con éxito un estudio de genotoxicidad requerido por la FDA. El estudio mostró que ONP-002 no causa daño al ADN ni aumenta el riesgo de cáncer en un modelo animal, incluso a dosis altas. Este resultado positivo despeja un importante obstáculo de seguridad para ONP-002, una nueva entidad química diseñada para la administración intranasal al cerebro.
Puntos clave:
- ONP-002 no mostró evidencia de mutaciones genéticas ni interrupción del ciclo celular
- El estudio se llevó a cabo bajo condiciones de Buenas Prácticas de Laboratorio (GLP)
- Oragenics está planeando un ensayo clínico de Fase II para ONP-002
- Se estima que las conmociones cerebrales afectan a 69 millones de personas anualmente en todo el mundo
- La empresa cree que ONP-002 será seguro para los pacientes con conmoción en el ensayo planeado
오라제닉스(뉴욕증권거래소 아메리칸: OGEN)는 뇌진탕 치료를 위한 주 후보 물질인 ONP-002가 FDA에서 요구하는 유전 독성 연구를 성공적으로 완료했다고 발표했습니다. 연구 결과, ONP-002는 동물 모델에서 DNA 손상이나 암 위험 증가를 유발하지 않는 것으로 나타났으며, 높은 용량에서도 안전하다는 것이 입증되었습니다. 이 긍정적인 결과는 뇌로의 비강 전달을 위해 설계된 새로운 화학 물질인 ONP-002의 중요한 안전성을 확보하는 데 도움을 줍니다.
핵심 사항:
- ONP-002는 유전적 변이 또는 세포 주기 방해의 증거를 보이지 않았습니다.
- 연구는 양호한 실험실(Good Laboratory, GLP) 조건 하에 수행되었습니다.
- 오라제닉스는 ONP-002에 대해 2상 임상 시험을 계획하고 있습니다.
- 뇌진탕은 전 세계적으로 매년 약 6,900만 명에게 영향을 미치는 것으로 추정됩니다.
- 회사는 예정된 임상 시험에서 ONP-002가 뇌진탕 환자에게 안전할 것이라고 믿습니다.
Oragenics (NYSE American: OGEN) a annoncé que son principal candidat au traitement des commotions cérébrales, ONP-002, a terminé avec succès une étude de génotoxicité requise par la FDA. L'étude a montré qu'ONP-002 ne cause pas de dommages ADN ni n'augmente le risque de cancer dans un modèle animal, même à des doses élevées. Ce résultat positif franchit un obstacle de sécurité important pour ONP-002, une nouvelle entité chimique conçue pour une administration intranasale au cerveau.
Points clés :
- ONP-002 n'a montré aucune preuve de mutations génétiques ou de perturbations du cycle cellulaire
- L'étude a été réalisée dans des conditions de Bonnes Pratiques de Laboratoire (BPL)
- Oragenics prévoit un essai clinique de Phase II pour ONP-002
- Les commotions cérébrales touchent environ 69 millions de personnes chaque année dans le monde
- La société pense qu'ONP-002 sera sûr pour les patients avec commotion dans l'essai prévu
Oragenics (NYSE American: OGEN) hat bekannt gegeben, dass sein Hauptkandidat zur Behandlung von Gehirnerschütterungen, ONP-002, erfolgreich eine von der FDA geforderte Genotoxizitätsstudie abgeschlossen hat. Die Studie ergab, dass ONP-002 auch bei hohen Dosen keinen DNA-Schaden verursacht oder das Krebsrisiko in einem Tiermodell erhöht. Dieses positive Ergebnis überwindet ein wichtiges Sicherheitshindernis für ONP-002, eine neue chemische Substanz, die für die intranasale Verabreichung an das Gehirn entwickelt wurde.
Wichtige Punkte:
- ONP-002 zeigte keine Hinweise auf genetische Mutationen oder Störungen des Zellzyklus
- Die Studie wurde unter guten Laborbedingungen (GLP) durchgeführt
- Oragenics plant eine klinische Phase-II-Studie für ONP-002
- Gehirnerschütterungen betreffen jährlich schätzungsweise 69 Millionen Menschen weltweit
- Das Unternehmen glaubt, dass ONP-002 für Patienten mit Gehirnerschütterungen in der geplanten Studie sicher sein wird
- ONP-002 successfully completed FDA-required genotoxicity study, showing no cancer-causing DNA damage
- The drug demonstrated safety at low, medium, and high doses in animal models
- ONP-002 cleared a important safety hurdle, paving the way for planned Phase II clinical trials
- The company has shown a safety margin in two-species toxicology program and cardiac safety with GLP hERG testing
- None.
The successful completion of the FDA-required genotoxicity study for ONP-002 is a significant milestone in Oragenics' drug development process. This outcome is crucial for advancing to clinical trials, as it demonstrates the drug's safety profile in terms of not causing DNA damage or increasing cancer risk.
The study's results, showing no evidence of genetic mutations across multiple dosages, provide a strong foundation for the drug's safety. This is particularly important for a treatment targeting neurological disorders, where long-term safety is paramount. The company's comprehensive approach, including previous toxicology and cardiac safety tests, further strengthens ONP-002's safety profile.
With an estimated
This positive development in Oragenics' drug pipeline could have significant implications for the company's financial outlook. Successfully completing the FDA-required genotoxicity study is a important step towards initiating Phase II clinical trials, potentially accelerating the drug's path to market.
The global concussion treatment market is substantial, given the high incidence rate. If ONP-002 proves effective in clinical trials, it could capture a significant market share, especially considering the current lack of approved treatments for concussion. This represents a substantial revenue opportunity for Oragenics.
However, investors should be cautious. Drug development is a high-risk, high-reward endeavor. While this news is positive, Oragenics will need significant capital to fund clinical trials and potential commercialization. The company's ability to secure funding and successfully navigate the regulatory process will be critical factors in realizing the drug's potential value.
– ONP-002 showed no cancer-causing DNA damage
– Phase II clinical trial being planned
SARASOTA, Fla., Aug. 12, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced its lead candidate for treating concussion, ONP-002, successfully completed a study that indicates it does not cause DNA damage and genotoxicity in an animal model. ONP-002 is a new chemical entity (NCE) designed to target the brain through delivery into the nasal cavity and onward to the brain. Prior to conducting a clinical trial, the U.S. Food and Drug Administration (FDA) requires that pharmaceuticals be tested on cells and animals to ensure they do not cause damage affecting cell division.
Oragenics conducted an in vivo (animal) study to determine if multi-day treatments of ONP-002 cause DNA damage and increased risk of cancer. Three concentrations of ONP-002 were used at a low, medium and high dose. Animal bone marrow was dissected and analyzed for DNA damage. The results showed no evidence of genetic mutations, suggesting that ONP-002 does not affect the cell cycle and therefore does not disrupt cell division that could be cancer-causing. Oragenics partnered with VivoPharm, Inc. to conduct this study under Good Laboratory (GLP) conditions. These results suggest that multi-day treatment for concussion using ONP-002 will not cause genotoxicity.
“We continue to be pleased with the safety profile of ONP-002. We have now shown a safety margin in our two-species toxicology program, cardiac safety with GLP hERG testing and no issue with cancer-causing DNA damage using the in vivo micronucleus assay. Oragenics strongly believes that ONP-002 will be safe for concussed patients in our planned Phase II clinical trial. We will continue to monitor systemic and intranasal safety parameters throughout the drug development program,” commented Michael Redmond, President of Oragenics.
Concussion is an unmet medical need. There are an estimated 69 million concussions annually reported worldwide. Common causes of concussion include falls, motor vehicle accidents, and contact sports. Other neurological disorders, including Alzheimer’s Disease, Parkinson’s Disease, and Chronic Traumatic Encephalopathy (CTE), have been linked to concussion. Post-concussion symptomology is linked to long-term disability and occurs in as high as
About Oragenics
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.
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, including without limitation statements regarding the ability of the Company to timely and successfully undertake Phase II clinical trial using its novel drug-device combination for the treatment of mild Traumatic Brain Injury. 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: the Company’s ability to advance the development of its product candidates, including the neurology assets, under the timelines and in accord with the milestones it projects; the Company’s ability to raise capital and obtain funding, non-dilutive or otherwise, for the development of its product candidates; the regulatory application process, research and development stages, and future clinical data and analysis relating to its product candidates, including any meetings, decisions by regulatory authorities, such as the FDA and investigational review boards, whether favorable or unfavorable; the Company’s ability to obtain, maintain and enforce necessary patent and other intellectual property protection; the nature of competition and development relating to concussion treatments; the Company’s expectations as to the outcome of preclinical studies and clinical trials and the potential benefits, activity, effectiveness and safety of its product candidates including as to administration, transmission, manufacturing, storage and distribution; and general economic and market conditions and risks, as well as other uncertainties described in our filings with the U.S. Securities and Exchange Commission. All information set forth is as of the date hereof unless otherwise indicated. You should consider these factors in evaluating the forward-looking statements included 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, should circumstances change, except as otherwise required by law.
Oragenics, Inc.
Janet Huffman, Chief Financial Officer
813-286-7900
jhuffman@oragenics.com
Investor Relations:
Rich Cockrell
CG Capital
404-736-3838
ogen@cg.capital
FAQ
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