Oragenics Inc. Announces Concussion Drug, ONP-002, Successfully Clears FDA-Required Cardiotoxicity Testing
Oragenics Inc. (NYSE American: OGEN) has announced that its lead candidate for treating concussion, ONP-002, has successfully completed FDA-required cardiotoxicity testing. The drug showed no signs of causing cardiac arrhythmia, demonstrating a strong safety margin for the heart. This clearance allows Oragenics to proceed with planning Phase II clinical trials for concussion treatment.
ONP-002 is a new chemical entity designed for intranasal delivery to target the brain. The potential addressable market for ONP-002 is significant, with an estimated 69 million concussions reported annually worldwide. The total annual healthcare cost for nonfatal traumatic brain injuries in the US exceeds $40.6 billion, highlighting the substantial market opportunity for effective concussion treatments.
Oragenics Inc. (NYSE American: OGEN) ha annunciato che il suo candidato principale per il trattamento delle commozioni cerebrali, ONP-002, ha completato con successo i test di cardiotossicità richiesti dalla FDA. Il farmaco non ha mostrato segni di causare aritmie cardiache, dimostrando un forte margine di sicurezza per il cuore. Questa approvazione consente a Oragenics di procedere con la pianificazione dei trial clinici di fase II per il trattamento delle commozioni cerebrali.
ONP-002 è un nuova entità chimica progettata per la somministrazione intranasale per mirare al cervello. Il mercato potenziale per ONP-002 è significativo, con circa 69 milioni di commozioni cerebrali segnalate annualmente in tutto il mondo. Il costo annuale totale per le lesioni cerebrali traumatiche non mortali negli Stati Uniti supera i 40,6 miliardi di dollari, evidenziando l'importante opportunità di mercato per trattamenti efficaci delle commozioni cerebrali.
Oragenics Inc. (NYSE American: OGEN) ha anunciado que su candidato principal para el tratamiento de conmociones cerebrales, ONP-002, ha completado con éxito las pruebas de cardiotoxicidad requeridas por la FDA. El fármaco no mostró signos de causar arritmias cardíacas, demostrando un fuerte margen de seguridad para el corazón. Esta aprobación permite a Oragenics avanzar en la planificación de ensayos clínicos de fase II para el tratamiento de las conmociones cerebrales.
ONP-002 es una nueva entidad química diseñada para la administración intranasal con el objetivo de alcanzar el cerebro. El mercado potencial para ONP-002 es significativo, con un estimado de 69 millones de conmociones cerebrales reportadas anualmente en todo el mundo. El costo annual total de atención médica por lesiones cerebrales traumáticas no fatales en EE. UU. supera los 40.6 mil millones de dólares, lo que resalta la considerable oportunidad de mercado para tratamientos efectivos de conmociones cerebrales.
Oragenics Inc. (NYSE American: OGEN)는 그들의 주요 후보 약물인 ONP-002가 FDA의 심장 독성 테스트를 성공적으로 완료했다고 발표했습니다. 이 약물은 심장 리듬 이상을 유발할 징후를 보이지 않았으며, 심장에 대한 강력한 안전 여유를 증명했습니다. 이 승인은 Oragenics가 2상 임상 시험 계획을 진행할 수 있도록 허용합니다.
ONP-002는 뇌를 목표로 하기 위해 설계된 새로운 화학 물질로, 비강 투여 방식으로 전달됩니다. ONP-002의 잠재적 시장은 상당히 크며, 전 세계에서 매년 약 6900만 건의 뇌진탕이 보고됩니다. 미국에서의 비치명적인 외상성 뇌손상에 대한 연간 총 의료 비용은 406억 달러를 초과하며, 이는 효과적인 뇌진탕 치료에 대한 상당한 시장 기회를 강조합니다.
Oragenics Inc. (NYSE American: OGEN) a annoncé que son principal candidat pour le traitement des commotions cérébrales, ONP-002, a réussi à compléter les tests de cardiotoxicité requis par la FDA. Le médicament n'a montré aucun signe de provoquer des arythmies cardiaques, démontrant une forte marge de sécurité pour le cœur. Cette autorisation permet à Oragenics de procéder à la planification des essais cliniques de phase II pour le traitement des commotions cérébrales.
ONP-002 est une nouvelle entité chimique conçue pour une administration intranasale ciblant le cerveau. Le marché potentiel pour ONP-002 est significatif, avec une estimation de 69 millions de commotions cérébrales rapportées chaque année dans le monde. Le coût annuel total des soins de santé pour les blessures cérébrales traumatiques non fatales aux États-Unis dépasse les 40,6 milliards de dollars, soulignant la formidable opportunité de marché pour des traitements efficaces des commotions cérébrales.
Oragenics Inc. (NYSE American: OGEN) hat bekannt gegeben, dass ihr Hauptkandidat zur Behandlung von Gehirnerschütterungen, ONP-002, erfolgreich die von der FDA geforderten Kardiotoxizitätstests abgeschlossen hat. Das Medikament zeigte keine Anzeichen von Herzrhythmusstörungen und demonstrierte eine hohe Sicherheitsmarge für das Herz. Diese Genehmigung ermöglicht es Oragenics, mit der Planung von Phase-II-Studien zur Behandlung von Gehirnerschütterungen fortzufahren.
ONP-002 ist eine neue chemische Entität, die für die intranasale Verabreichung zur gezielten Behandlung des Gehirns entwickelt wurde. Der potenzielle adressierbare Markt für ONP-002 ist erheblich, da jährlich weltweit etwa 69 Millionen Gehirnerschütterungen gemeldet werden. Die jährlichen Gesamtkosten des Gesundheitswesens für nicht tödliche traumatische Hirnverletzungen in den USA übersteigen 40,6 Milliarden Dollar, was die beträchtliche Marktchance für effektive Behandlungen von Gehirnerschütterungen unterstreicht.
- ONP-002 successfully passed FDA-required cardiotoxicity testing, demonstrating a strong cardiac safety margin
- Clearance to proceed with planning Phase II clinical trials for concussion treatment
- Large addressable market with 69 million estimated annual concussion cases globally
- Potential to address a significant unmet medical need in concussion treatment
- None.
Insights
The successful completion of cardiotoxicity testing for ONP-002 is a significant milestone in Oragenics' drug development process. This outcome is important for two reasons:
- It demonstrates a strong safety profile for ONP-002, particularly regarding cardiac safety, which is a critical factor in drug approval.
- It paves the way for Phase II clinical trials, bringing the drug closer to potential market approval.
The intranasal delivery method of ONP-002 is innovative and could offer advantages in treating concussions by targeting the brain directly. With an estimated
This news is positive for Oragenics from a financial perspective. The global addressable market of 69 million concussions annually represents a significant opportunity. If ONP-002 successfully navigates clinical trials and reaches the market, it could potentially capture a portion of the
- The long road ahead in clinical trials and potential regulatory hurdles
- The company's financial position and burn rate during the development process
- Potential competition in the concussion treatment market
While promising, it's important to note that many drugs fail in later-stage trials and success is not guaranteed. Investors should closely monitor Oragenics' cash position and upcoming milestones in the ONP-002 development program.
The potential of ONP-002 in treating concussions is scientifically intriguing. Its intranasal delivery method could offer advantages in crossing the blood-brain barrier, a common challenge in neurological treatments. The link between concussions and other neurological disorders like Alzheimer's, Parkinson's and CTE underscores the importance of effective concussion treatments. However, several points warrant consideration:
- The mechanism of action for ONP-002 in treating concussions needs further elucidation
- The
20% of individuals experiencing post-concussion symptoms represents a significant subgroup that may benefit from this treatment - The potential for ONP-002 to prevent long-term neurological complications remains to be studied
While promising, the true efficacy and long-term benefits of ONP-002 will only be determined through rigorous clinical trials.
The potential addressable market opportunity for ONP-002 includes an estimated 69 million concussions globally
SARASOTA, Fla., Aug. 08, 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 successfully completed a study that indicates ONP-002 does not cause cardiotoxicity. 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 pharmaceuticals to be tested on cardiac receptors to ensure that they do not show any causes of electrical malformations.
Oragenics conducted hERG (human Ether-à-go-go-Related Gene) ion channel studies on ONP-002 under Good Laboratory Practices (GLP) with Charles River Laboratories. Like previous non-GLP hERG studies, inhibitory concentrations were greater than 10 micromolar. Based on Phase I ONP-002 clinical trial dosing and subsequent blood plasma concentrations, ONP-002 is expected to have a large cardiac safety margin, suggesting that ONP-002 treatment for concussion will not cause cardiac arrhythmia.
“We are pleased that ONP-002 has demonstrated a strong safety margin for the heart, enabling us to continue planning the Phase II trials. Safety remains our top priority, and we will continuously monitor all safety parameters throughout the trials,” stated Michael Redmond, President of Oragenics. “Furthermore, a Phase II study is being planned to further evaluate the drug in concussed patients.”
Concussion is a significant unmet medical need, with an estimated 69 million cases reported annually worldwide. Common causes of concussions include falls, motor vehicle accidents, and contact sports. According to the CDC, the total annual healthcare cost for nonfatal traumatic brain injuries (TBIs) exceeds
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
What is ONP-002 and what did Oragenics announce about it?
What is the significance of ONP-002 passing cardiotoxicity testing for OGEN?
What is the potential market size for ONP-002 according to Oragenics?
How is ONP-002 designed to treat concussions?
