Oragenics Inc. Completes Spray Dry Drug Manufacturing and Intranasal Device Filling in Anticipation of Phase IIa Clinical Trial in Concussed Patients
Oragenics Inc. (NYSE American: OGEN) has completed the spray-dried formulation and nasal device filling for its lead candidate, ONP-002, in preparation for a Phase IIa clinical trial targeting concussion treatment. The trial, set to enroll 40 concussed patients in Australia, will evaluate the efficacy of ONP-002 administered intranasally within 8 hours of injury. This novel neurosteroid aims to reduce negative outcomes post-concussion through its anti-inflammatory effects.
Key developments include:
- Production of placebo and ONP-002 as spray-dried nanoparticle formulations
- Loading of the powder into Oragenics' proprietary breath-propelled intranasal device
- Initiation of a stability program for both the drug formula and device
The trial design involves twice-daily dosing for five consecutive days, with patient-reported outcomes and blood biomarkers expected to be part of the evaluation process.
Oragenics Inc. (NYSE American: OGEN) ha completato la formulazione spray-dried e il riempimento del dispositivo nasale per il suo candidato principale, ONP-002, in preparazione per un trial clinico di Fase IIa che mira al trattamento delle commozioni cerebrali. Lo studio, che si propone di arruolare 40 pazienti con commozione cerebrale in Australia, valuterà l'efficacia dell'ONP-002 somministrato intranasalmente entro 8 ore dall'infortunio. Questo nuovo neurosteroide mira a ridurre gli esiti negativi post-commozione grazie ai suoi effetti anti-infiammatori.
Sviluppi chiave includono:
- Produzione di placebo e ONP-002 come formulazioni di nanoparticelle spray-dried
- Caricamento della polvere nel dispositivo intranasale a propulsione aerea proprietario di Oragenics
- Avvio di un programma di stabilità sia per la formula del farmaco che per il dispositivo
Il design dello studio prevede un dosaggio due volte al giorno per cinque giorni consecutivi, con risultati segnalati dai pazienti e biomarcatori ematici che si prevede siano parte del processo di valutazione.
Oragenics Inc. (NYSE American: OGEN) ha completado la formulación en spray-dried y el llenado del dispositivo nasal para su candidato principal, ONP-002, en preparación para un ensayo clínico de Fase IIa dirigido al tratamiento de conmociones cerebrales. El ensayo, que se llevará a cabo en Australia, reclutará a 40 pacientes con conmociones, y evaluará la eficacia de ONP-002 administrado intranasalmente dentro de las 8 horas posteriores a la lesión. Este nuevo neuroesteroide tiene como objetivo reducir los resultados negativos post-conmoción a través de sus efectos antiinflamatorios.
Los desarrollos clave incluyen:
- Producción de placebo y ONP-002 como formulaciones de nanopartículas en spray-dried
- Carga del polvo en el dispositivo intranasal propulsado por aire de Oragenics
- Inicio de un programa de estabilidad tanto para la fórmula del medicamento como para el dispositivo
El diseño del ensayo implica una dosificación dos veces al día durante cinco días consecutivos, con resultados reportados por los pacientes y biomarcadores en sangre que se espera sean parte del proceso de evaluación.
오라제닉스 Inc. (NYSE American: OGEN)은 뇌진탕 치료를 목표로 하는 2상 임상 시험 준비를 위해 주요 후보 물질인 ONP-002의 스프레이 건조 제형과 비강 장치 충전을 완료했습니다. 이 시험은 호주에서 40명의 뇌진탕 환자를 모집할 예정이며, 부상 후 8시간 이내에 비강으로 투여된 ONP-002의 효능을 평가할 것입니다. 이 새로운 신경 스테로이드의 목적은 항염증 효과를 통해 뇌진탕 후 부정적인 결과를 줄이는 것입니다.
주요 발전 사항은 다음과 같습니다:
- 플라세보와 ONP-002의 스프레이 건조 나노입자 제형 생산
- 오라제닉스의 독점적인 공기 추진 비강 장치에 분말을 장착
- 약물 제형과 장치에 대한 안정성 프로그램 시작
시험 설계는 5일 연속으로 하루 두 번 복용하는 것을 포함하며, 환자 보고 결과와 혈액 바이오마커가 평가 과정의 일부가 될 것으로 예상됩니다.
Oragenics Inc. (NYSE American: OGEN) a terminé la formulation spray-dried et le remplissage de l'appareil nasal pour son candidat principal, ONP-002, en préparation d'un essai clinique de Phase IIa ciblant le traitement des commotions cérébrales. L'essai, qui visera à recruter 40 patients victimes de commotions en Australie, évaluera l'efficacité de l'ONP-002 administré par voie intranasale dans les 8 heures suivant la blessure. Ce nouveau neurostéroïde vise à réduire les conséquences négatives post-commotion grâce à ses effets anti-inflammatoires.
Les développements clés comprennent :
- Production de placebo et d'ONP-002 sous forme de formulations de nanoparticules spray-dried
- Chargement de la poudre dans l'appareil nasal propulsé par air d'Oragenics
- Lancement d'un programme de stabilité pour la formule du médicament et le dispositif
Le design de l'essai prévoit une administration deux fois par jour pendant cinq jours consécutifs, avec des résultats rapportés par les patients et des biomarqueurs sanguins qui devraient faire partie du processus d'évaluation.
Oragenics Inc. (NYSE American: OGEN) hat die spray-getrocknete Formulierung und das Befüllen des Nasengeräts für seinen Hauptkandidaten, ONP-002, abgeschlossen, um sich auf eine Phase-IIa-Studie zur Behandlung von Gehirnerschütterungen vorzubereiten. Die Studie, die 40 Patienten mit Gehirnerschütterungen in Australien rekrutieren soll, wird die Wirksamkeit von ONP-002 bewerten, das intranasal innerhalb von 8 Stunden nach der Verletzung verabreicht wird. Dieses neuartige Neurosteroid zielt darauf ab, negative Folgen nach einer Gehirnerschütterung durch seine entzündungshemmenden Eigenschaften zu verringern.
Wichtige Entwicklungen umfassen:
- Produktion von Placebo und ONP-002 als spray-getrocknete Nanopartikelformulierung
- Befüllung des Pulvers in Oragenics' proprietärem, luftbetriebenem Nasengerät
- Beginn eines Stabilitätsprogramms für sowohl die Arzneimittelformulierung als auch das Gerät
Das Studiendesign sieht eine Dosisverabreichung zweimal täglich über fünf aufeinanderfolgende Tage vor, wobei die Ergebnisse der Patientenberichte und Blutbiomarker voraussichtlich Teil des Evaluierungsprozesses sein werden.
- Completion of spray-dried formulation and nasal device filling for ONP-002, advancing towards Phase IIa clinical trial
- Innovative drug delivery method using spray-dried nanoparticle formulation and breath-propelled intranasal device
- Potential first-in-class pharmaceutical treatment for concussion, addressing an unmet medical need
- Rapid treatment initiation within 8 hours of injury, potentially improving efficacy
- Early-stage clinical development (Phase IIa) with no guarantee of success
- sample size of 40 patients in the planned clinical trial
- Potential competition from other concussion treatments in development
Insights
The completion of spray-dried drug manufacturing and intranasal device filling for ONP-002 marks a significant milestone in Oragenics' journey towards developing a potential first-in-class treatment for concussions. This achievement is important as it enables the planned Phase IIa clinical trial, which could provide valuable insights into the drug's efficacy.
The nanoparticle formulation and intranasal delivery method are innovative approaches that could enhance brain exposure and potentially improve treatment outcomes. The ability to start treatment within 8 hours of injury in emergency departments could be a game-changer in concussion management, potentially reducing long-term neurological consequences.
However, investors should note that this is still an early-stage clinical trial and success is not guaranteed. The 40-patient sample size is relatively small and more extensive studies will be needed to fully establish efficacy and safety. The focus on both patient-reported outcomes and blood biomarkers is a positive aspect, potentially providing a comprehensive assessment of the drug's effects.
While this news doesn't directly impact Oragenics' financials, it represents a positive development in their product pipeline. The completion of drug manufacturing and device filling suggests the company is on track with its development timeline, which could be viewed favorably by investors.
However, it's important to note that Oragenics is still in the clinical stage, with no approved products or significant revenue streams. The upcoming Phase IIa trial will likely incur substantial costs and investors should be prepared for potential future capital raises to fund ongoing research and development.
The market potential for a concussion treatment could be substantial, given the high incidence of concussions and lack of current pharmaceutical options. If successful, ONP-002 could capture a significant market share. However, the road to approval is long and uncertain, with many potential hurdles ahead.
Oragenics' progress with ONP-002 is noteworthy in the context of the unmet medical need for concussion treatments. The company's approach of using a spray-dried nanoparticle formulation delivered via a breath-propelled intranasal device is innovative and could offer advantages in terms of rapid delivery and improved brain exposure.
The focus on early intervention (within 8 hours of injury) aligns with current understanding of concussion pathophysiology, potentially offering a chance to mitigate long-term effects. However, this tight treatment window could pose logistical challenges in real-world settings.
While promising, investors should be cautious. The concussion treatment landscape is challenging, with many failed attempts in the past. Oragenics will need to demonstrate clear efficacy and safety in larger trials to stand a chance of regulatory approval. The company's success will also depend on its ability to navigate the complex regulatory pathway and potentially partner with larger pharmaceutical companies for later-stage development and commercialization.
• Falls and car accidents lead incidence of concussions in emergency departments
• Spray-dried drug formulation allows for easy delivery to patients
• No pharmaceutical treatment is available for concussion; drug, ONP-002, could be first of its kind to treat concussion
SARASOTA, Fla., Aug. 21, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN) (“the Company”), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced the completion of its spray-dried formulation and filling in the nasal device for its lead candidate, ONP-002, for concussion. ONP-002 is a new chemical entity (NCE) designed to target the brain through delivery into the nasal cavity. The prefilled formulation is intended to provide the needed drug-device dosing for the planned Phase IIa clinical trial in concussed patients.
For the trial, the Company produced both placebo and ONP-002 drug for use in the Phase IIa clinical trial to be conducted in Australia. The work included the production of ONP-002 as a spray-dried nanoparticle formulation, loading of the powder in Oragenics’ novel breath-propelled intranasal device, and initiating a stability program of both the drug formula alone and within the device. The Phase IIa clinical trial is expected to enroll 40 concussed patients who will receive 1:1 either placebo or the ONP-002 drug, with doses given twice a day for five consecutive days following injury. The trial aims to start treatment within 8 hours of the injury in the emergency department. It is anticipated that patient-reported outcomes and blood biomarkers will be included in the evaluation.
“In preparing for the Phase IIa study, we wanted to ensure that ONP-002 could be formulated as a nanoparticle and delivered intranasally as a powder to improve brain exposure. The anti-inflammatory effects of our novel neurosteroid are designed to reduce negative outcomes after a concussion. We believe the combination of the spray-dried powder in our device is ideal for field delivery, increasing the chances of stopping the neuropathology of a concussive injury early,” commented Michael Redmond, President for Oragenics.
About Concussion
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 fighting infectious diseases and neurological conditions, 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 the purpose of Oragenics' Phase IIa clinical trial for ONP-002?
How is ONP-002 administered to patients in the Oragenics clinical trial?
When is the treatment initiated in Oragenics' concussion trial for ONP-002 (OGEN)?
What makes Oragenics' ONP-002 (OGEN) unique in the field of concussion treatment?
