Oragenics Inc. Successfully Completes Key FDA-Recognized Study for ONP-002
Oragenics Inc. (NYSE American: OGEN) has successfully completed a key FDA-recognized study for its concussion drug, ONP-002. The study demonstrated that the intranasal delivery of ONP-002 effectively targets areas in the nose connected to the brain, increasing the likelihood of rapid brain treatment post-concussion. This achievement paves the way for Oragenics to proceed with Phase II human testing in emergency room patients, aiming to administer the first dose within 8 hours of injury.
The study utilized a special nasal spray device and an FDA-accepted anatomical model of the interior nose. Results showed promising drug distribution in areas where it can be quickly absorbed into the brain. With approximately 69 million people affected by concussions annually and no current pharmaceutical treatment available, ONP-002 represents a significant potential breakthrough in concussion treatment.
Oragenics Inc. (NYSE American: OGEN) ha completato con successo uno studio chiave riconosciuto dalla FDA per il suo farmaco contro le commozioni cerebrali, ONP-002. Lo studio ha dimostrato che la somministrazione intranasale di ONP-002 mira efficacemente alle aree del naso collegate al cervello, aumentando la probabilità di un trattamento rapido del cervello dopo una commozione cerebrale. Questo risultato apre la strada ad Oragenics per procedere con test umani di Fase II presso i pazienti in pronto soccorso, con l'obiettivo di somministrare la prima dose entro 8 ore dall'infortunio.
Lo studio ha utilizzato un dispositivo per spray nasale speciale e un modello anatomico dell'interno del naso accettato dalla FDA. I risultati hanno mostrato una distribuzione promettente del farmaco in aree dove può essere rapidamente assorbito dal cervello. Con circa 69 milioni di persone colpite da commozioni cerebrali ogni anno e nessun trattamento farmaceutico attualmente disponibile, ONP-002 rappresenta una potenziale svolta significativa nel trattamento delle commozioni cerebrali.
Oragenics Inc. (NYSE American: OGEN) ha completado con éxito un estudio clave reconocido por la FDA para su medicamento contra las conmociones cerebrales, ONP-002. El estudio demostró que la administración intranasal de ONP-002 apunta efectivamente a áreas en la nariz conectadas al cerebro, aumentando la probabilidad de un tratamiento cerebral rápido después de una conmoción. Este logro allana el camino para que Oragenics proceda con pruebas humanas de Fase II en pacientes de salas de emergencia, con el objetivo de administrar la primera dosis dentro de las 8 horas siguientes a la lesión.
El estudio utilizó un dispositivo especial de aerosol nasal y un modelo anatómico del interior de la nariz aceptado por la FDA. Los resultados mostraron una distribución prometedora del medicamento en áreas donde puede ser rápidamente absorbido por el cerebro. Con aproximadamente 69 millones de personas afectadas por conmociones cerebrales cada año y sin tratamiento farmacéutico actual disponible, ONP-002 representa un avance potencial significativo en el tratamiento de conmociones.
오라제닉스 주식회사(뉴욕 증권 거래소 아메리칸: OGEN)가 FDA에서 인정받은 핵심 연구를 성공적으로 완료했습니다. 이 연구는 그들의 뇌진탕 약물인 ONP-002에 대한 것입니다. 연구 결과 ONP-002의 비강 투여가 뇌와 연결된 코의 부위를 효과적으로 겨냥하여 뇌진탕 후 신속한 뇌 치료의 가능성을 증가시킨 것으로 나타났습니다. 이 성과는 오라제닉스가 응급실 환자에 대한 2상 임상 시험을 진행할 수 있는 길을 열어주며, 부상 후 8시간 이내에 첫 투여를 목표로 하고 있습니다.
연구는 특별한 비강 스프레이 장치와 FDA에서 승인된 코 내부의 해부학적 모델을 사용했습니다. 결과는 뇌로 빠르게 흡수될 수 있는 부위에서의 약물 분포가 유망하다는 것을 보여주었습니다. 매년 약 6,900만 명이 뇌진탕에 영향을 받으며 현재 이용 가능한 약리학적 치료법이 없는 상황에서, ONP-002는 뇌진탕 치료에서 중요한 잠재적 돌파구를 나타냅니다.
Oragenics Inc. (NYSE American: OGEN) a réussi à compléter une étude clé reconnue par la FDA pour son médicament contre les commotions cérébrales, ONP-002. L'étude a démontré que l'administration intranasale d'ONP-002 cible efficacement les zones du nez connectées au cerveau, augmentant ainsi la probabilité d'un traitement cérébral rapide après une commotion. Cet accomplissement ouvre la voie à Oragenics pour procéder aux essais cliniques de Phase II chez des patients aux urgences, visant à administrer la première dose dans les 8 heures suivant la blessure.
L'étude a utilisé un dispositif spécial de spray nasal et un modèle anatomique de l'intérieur du nez accepté par la FDA. Les résultats ont montré une distribution prometteuse du médicament dans des zones où il peut être rapidement absorbé par le cerveau. Avec environ 69 millions de personnes affectées par des commotions cérébrales chaque année et aucun traitement pharmaceutique actuellement disponible, ONP-002 représente une avancée potentielle significative dans le traitement des commotions cérébrales.
Oragenics Inc. (NYSE American: OGEN) hat erfolgreich eine wichtige, von der FDA anerkannte Studie für sein Medikament gegen Gehirnerschütterungen, ONP-002, abgeschlossen. Die Studie zeigte, dass die intranasale Verabreichung von ONP-002 effektiv Bereiche in der Nase anspricht, die mit dem Gehirn verbunden sind, und die Wahrscheinlichkeit einer schnellen Behandlung des Gehirns nach einer Gehirnerschütterung erhöht. Dieser Erfolg ebnet den Weg für Oragenics, mit Phase-II-Tests an Patienten in der Notaufnahme fortzufahren, mit dem Ziel, die erste Dosis innerhalb von 8 Stunden nach der Verletzung zu verabreichen.
In der Studie wurde ein spezielles Nasenspray-Gerät und ein von der FDA akzeptiertes anatomisches Modell des inneren Nasenraums verwendet. Die Ergebnisse zeigten eine vielversprechende Verteilung des Medikaments in Bereichen, die schnell ins Gehirn aufgenommen werden können. Mit etwa 69 Millionen Menschen, die jährlich von Gehirnerschütterungen betroffen sind, und derzeit keinem verfügbaren pharmazeutischen Behandlungsansatz, stellt ONP-002 einen potenziellen bedeutenden Durchbruch in der Behandlung von Gehirnerschütterungen dar.
- Successful completion of FDA-recognized intranasal casting study for ONP-002
- Promising results showing effective targeting of brain-connected nasal areas
- Advancement to Phase II human testing in emergency room patients
- Potential first-to-market pharmaceutical treatment for concussions
- Large market opportunity with 69 million concussions occurring annually
- ONP-002 still in early stages of development, with no guarantee of FDA approval
- Potential competition from other companies developing concussion treatments
- Possible challenges in meeting the 8-hour post-injury treatment window
Insights
The successful completion of the FDA-recognized intranasal casting study for ONP-002 is a significant milestone for Oragenics. This study demonstrates that the drug effectively targets areas in the nasal passage connected to the brain, increasing its potential efficacy in treating concussions. The results are particularly promising for several reasons:
- It validates the drug delivery method, showing that ONP-002 can reach the brain quickly after administration.
- The study's acceptance by the FDA in submissions adds credibility to Oragenics' approach.
- It paves the way for Phase II clinical trials, bringing the drug closer to potential market approval.
With
SARASOTA, Fla., Oct. 08, 2024 (GLOBE NEWSWIRE) -- Oragenics Inc. (NYSE American: OGEN), a company focused on developing new treatments for brain-related health conditions, has completed a key study for their new concussion drug, ONP-002. This drug is designed to be delivered through the nose, which could help it reach the brain quickly after a head injury.
The recent study shows that the drug successfully targets areas inside the nose that are connected to the brain. This makes it more likely to reach and treat the brain after a concussion. Intranasal casting studies are valued by the FDA for pharmaceuticals delivered via the nasal passage and accept such studies in FDA submissions. Oragenics is now preparing to move forward with human testing (Phase II) in patients who come to the emergency room with a concussion, aiming to give the first dose of the drug within 8 hours of the injury.
"In preparing for our Phase II study, we wanted to study whether our nasal spray device would give ONP-002 an increased chance of reaching the brain quickly after a concussion. The study results are promising, as they show the drug targets areas in the nose directly linked to the brain. This should increase the chances of the drug being effective in treating concussion and reduces the likelihood of it being swallowed, which is another encouraging sign," said Michael Redmond, President of Oragenics.
In this study, ONP-002 was tested using a special nasal spray device. The goal of intranasal casting studies is to identify where the drug lands inside an anatomical model of the interior nose that is made from cast metal (AINI). The model is standard for intranasal drug delivery and is accepted by the FDA as a surrogate for the actual nasal passage. The results were promising, showing that the drug spreads well in the areas of the nose where it can be quickly absorbed into the brain. This makes it a strong candidate for potentially helping people recover from concussions.
Concussions are a common problem, with around 69 million people affected every year. Many concussions happen due to falls, car accidents, or sports injuries, and long-term symptoms can develop in up to
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.
About Nasal Casting
The FDA values studies on nasal drug delivery systems and accepts them in submissions for pharmaceuticals that use the nasal passage. These studies are critical for assessing the bioavailability and bioequivalence of drugs, particularly nasal aerosols and sprays. The FDA's guidance on bioavailability and bioequivalence emphasizes the use of in vitro and in silico methods (like computational simulations) to assess how drugs are deposited and distributed within the nasal cavity. These methods help ensure that both new drug applications (NDAs) and abbreviated new drug applications (ANDAs) meet regulatory requirements.
Reference Links:
- Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action.
- Computational Simulations Shed Light on Factors Affecting Nasal Spray Distribution.
Forward-Looking Statements
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Investor Relations:
Rich Cockrell
404.736.3838
achv@cg.capital
FAQ
What is the significance of Oragenics' recent study for ONP-002?
When will Oragenics (OGEN) begin Phase II trials for ONP-002?
How does ONP-002 differ from current concussion treatments?
What is the market potential for Oragenics' (OGEN) concussion drug?
