Oragenics Inc. Shows Concussion Drug, ONP-002, Designed for Acute Field-Delivery Stable Across a Wide Temperature Range
Oragenics Inc. (NYSE American: OGEN) has announced that its lead candidate for treating concussion, ONP-002, demonstrates stability across a wide temperature range (-20°C to 104°C). This eliminates the need for cold storage, making it suitable for field use in sports and military operations. Key points:
1. ONP-002 is a new chemical entity designed for intranasal delivery to treat concussions.
2. The drug maintains over 99% purity after 3 months at various temperatures.
3. Formulated as a spray-dried powder for improved stability.
4. No FDA-approved pharmaceutical treatment currently exists for concussions.
5. An estimated 69 million concussions are reported annually worldwide.
Oragenics aims to address the unmet medical need for concussion treatment, potentially impacting related neurological disorders like Alzheimer's, Parkinson's, and CTE.
Oragenics Inc. (NYSE American: OGEN) ha annunciato che il suo candidato principale per il trattamento delle commozioni cerebrali, ONP-002, dimostra stabilità su un ampio intervallo di temperature (-20°C a 104°C). Ciò elimina la necessità di stoccaggio a freddo, rendendolo adatto per l'uso sul campo in ambito sportivo e militare. Punti chiave:
1. ONP-002 è una nuova entità chimica progettata per la somministrazione intranasale per trattare le commozioni cerebrali.
2. Il farmaco mantiene oltre il 99% di purezza dopo 3 mesi a varie temperature.
3. Formulato come polvere spray-dry per una stabilità migliorata.
4. Attualmente non esiste alcun trattamento farmacologico approvato dalla FDA per le commozioni cerebrali.
5. Si stima che ogni anno vengano segnalate 69 milioni di commozioni cerebrali a livello mondiale.
Oragenics intende affrontare il bisogno medico insoddisfatto per il trattamento delle commozioni cerebrali, impattando potenzialmente su disturbi neurologici correlati come l'Alzheimer, il Parkinson e il CTE.
Oragenics Inc. (NYSE American: OGEN) ha anunciado que su principal candidato para el tratamiento de conmociones cerebrales, ONP-002, demuestra estabilidad en un amplio rango de temperaturas (-20°C a 104°C). Esto elimina la necesidad de almacenamiento en frío, haciéndolo adecuado para su uso en el campo en deportes y operaciones militares. Puntos clave:
1. ONP-002 es una nueva entidad química diseñada para la entrega intranasal para tratar conmociones cerebrales.
2. El medicamento mantiene más del 99% de pureza después de 3 meses a varias temperaturas.
3. Formulado como un polvo seco en spray para una mejor estabilidad.
4. Actualmente no existe ningún tratamiento farmacéutico aprobado por la FDA para las conmociones cerebrales.
5. Se estima que se reportan anualmente 69 millones de conmociones cerebrales en todo el mundo.
Oragenics busca abordar la necesidad médica no satisfecha para el tratamiento de las conmociones cerebrales, impactando potencialmente trastornos neurológicos relacionados como el Alzheimer, el Parkinson y el CTE.
Oragenics Inc. (NYSE American: OGEN)는 그들의 주요 후보인 ONP-002가 광범위한 온도 범위(-20°C에서 104°C)에서 안정성을 보여준다고 발표했습니다. 이는 냉장 보관의 필요성을 없애주어 스포츠와 군사 작전에서 현장 사용에 적합하게 만듭니다. 주요 사항:
1. ONP-002는 뇌진탕 치료를 위해 비강 전달 방식으로 설계된 신약 물질입니다.
2. 이 약물은 다양한 온도에서 3개월 후에도 99% 이상의 순도를 유지합니다.
3. 안정성이 향상된 스프레이 드라이 파우더 형태로 제조되었습니다.
4. 현재 뇌진탕에 대해 FDA 승인을 받은 약물 치료법은 없습니다.
5. 세계적으로 연간 약 6,900만 건의 뇌진탕이 보고됩니다.
Oragenics는 뇌진탕 치료를 위한 충족되지 않은 의료 수요를 해결하고자 하며, 이는 알츠하이머, 파킨슨병, CTE와 같은 관련 신경장애에 잠재적으로 영향을 미칠 수 있습니다.
Oragenics Inc. (NYSE American: OGEN) a annoncé que son principal candidat pour le traitement des commotions cérébrales, ONP-002, démontre une stabilité sur une large plage de températures (-20°C à 104°C). Cela élimine le besoin de stockage à froid, le rendant adapté à une utilisation sur le terrain dans le sport et les opérations militaires. Points clés :
1. ONP-002 est une nouvelle entité chimique conçue pour l'administration intranasale pour traiter les commotions cérébrales.
2. Le médicament conserve plus de 99 % de pureté après 3 mois à diverses températures.
3. Formulé sous forme de poudre spray séchée pour une stabilité améliorée.
4. Il n'existe actuellement aucun traitement pharmaceutique approuvé par la FDA pour les commotions cérébrales.
5. On estime que 69 millions de commotions cérébrales sont signalées chaque année dans le monde.
Oragenics vise à répondre aux besoins médicaux non satisfaits en matière de traitement des commotions cérébrales, ce qui pourrait également avoir un impact sur des troubles neurologiques connexes tels que la maladie d'Alzheimer, la maladie de Parkinson et le CTE.
Oragenics Inc. (NYSE American: OGEN) hat angekündigt, dass sein Hauptkandidat zur Behandlung von Gehirnerschütterungen, ONP-002, Stabilität über einen breiten Temperaturbereich (-20°C bis 104°C) aufweist. Dies macht eine Kühlung überflüssig und eignet sich somit für den Einsatz vor Ort in Sport- und Militäreinsätzen. Wichtige Punkte:
1. ONP-002 ist eine neue chemische Substanz, die für die intranasale Verabreichung zur Behandlung von Gehirnerschütterungen entwickelt wurde.
2. Das Medikament behält nach 3 Monaten bei verschiedenen Temperaturen über 99% Reinheit.
3. Formuliert als sprühgetrocknetes Pulver für verbesserte Stabilität.
4. Derzeit gibt es keine von der FDA zugelassenen pharmazeutischen Behandlungen für Gehirnerschütterungen.
5. Es wird geschätzt, dass jährlich weltweit 69 Millionen Gehirnerschütterungen gemeldet werden.
Oragenics zielt darauf ab, den ungedeckten medizinischen Bedarf an Gehirnerschütterungsbehandlungen zu decken, was potenziell Auswirkungen auf verwandte neurologische Erkrankungen wie Alzheimer, Parkinson und CTE haben könnte.
- ONP-002 demonstrates stability across a wide temperature range (-20°C to 104°C), eliminating the need for cold storage
- The drug maintains over 99% purity after 3 months at various temperatures
- ONP-002 is formulated as a spray-dried powder, improving stability in extreme temperatures
- The company has completed the synthesis of its ONP-002 drug batch for the planned Phase II clinical trial
- None.
Insights
The stability of ONP-002 across a wide temperature range (-20°C to 104°C) is a significant advancement in concussion treatment. This eliminates the need for cold chain logistics, potentially reducing costs and improving accessibility in various settings, from sports fields to military operations. The spray-dried powder formulation further enhances its field-use potential.
With
Oragenics' (NYSE: OGEN) development of ONP-002 positions the company in a potentially lucrative market with no current FDA-approved pharmaceutical treatments for concussions. The drug's stability across a wide temperature range could provide a competitive advantage and potentially reduce distribution costs.
Investors should note that while this news is positive, Oragenics is still in the clinical trial phase. The upcoming Phase II trial will be critical in determining ONP-002's efficacy and safety. If successful, it could lead to significant revenue potential given the large market size of 69 million concussions annually. However, drug development carries inherent risks and investors should consider the company's financial position and burn rate as it progresses through clinical trials.
ONP-002's stability across a wide temperature range is a game-changer for sideline concussion management in sports. Current protocols often rely on subjective assessments and rest, lacking immediate pharmacological interventions. This drug could potentially revolutionize acute concussion care in sports settings, from professional leagues to school athletics.
The intranasal delivery method is particularly advantageous, allowing for quick administration without the need for specialized medical personnel. This could significantly reduce the time between injury and treatment, potentially mitigating long-term effects. However, it's important to await clinical trial results to confirm efficacy and safety. If successful, ONP-002 could become a standard part of sideline medical kits, potentially changing concussion management protocols across all levels of sports.
• ONP-002 stability eliminates need for cumbersome cold storage
• No FDA-approved pharmaceutical treatment available for concussion
SARASOTA, Fla., Aug. 14, 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, is stable across a wide temperature range, eliminating the need for cumbersome cold storage for the drug device combination. ONP-002 is a new chemical entity (NCE) designed to target the brain through a breath propelled delivery system into the nasal cavity to treat concussions.
Oragenics recently completed the synthesis of its ONP-002 drug batch for the planned Phase II clinical trial. The company reports 3-month stability with over
Field conditions for contact sports and military operations involve a wide range of temperatures that may affect the stability and effectiveness of drugs intended for acute concussion treatment. ONP-002 has been formulated as a spray-dried powder to improve stability in extreme temperatures. In contrast, narrow temperature storage protocols can be cumbersome and pose greater risk for non-compliance during shipping and field operations.
“We understand the importance of getting ONP-002 into the brain quickly after concussive injury to squelch the pathological cascade of inflammation and oxidative stress. As an emergency medicine physician, I am especially excited to find out that Oragenics’ drug is expected to maintain its function out in the field where we plan to administer the initial dose. While there is currently no drug treatment for concussion, we believe strongly that targeting the brain intranasally during the acute field-phase will improve treatment efficacy,” commented Frank Peacock, MD and Chief Clinical Officer for 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, also known as concussion, and for treating Niemann Pick Disease Type C, 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 the temperature stability range of Oragenics' ONP-002 concussion drug (OGEN)?
How is Oragenics' ONP-002 (OGEN) formulated to improve stability?
What is the current status of Oragenics' ONP-002 (OGEN) clinical trials?
How many concussions are reported annually worldwide, according to Oragenics' press release (OGEN)?
