Oragenics, Inc. Announces Partnership with BRAINBox Solutions to Revolutionize Concussion Diagnosis and Treatment
Oragenics (NYSE American: OGEN) has announced a strategic partnership with BRAINBox Solutions to develop the first intranasal therapy for mild traumatic brain injury (mTBI) and concussion. The collaboration combines BRAINBox's diagnostic platform, which uses biomarkers, neuropsychological assessments, and AI analytics, with Oragenics' therapeutic candidate ONP-002.
The partnership aims to create a comprehensive trigger-to-treat platform. BRAINBox's testing platform provides diagnostic and prognostic insights, while ONP-002, an intranasal neurosteroid therapeutic, has shown promise in preclinical studies for reducing brain injury effects. Phase I clinical trials demonstrated ONP-002's tolerability and ease of use.
With over 5 million concussions occurring annually in the U.S., this collaboration addresses a significant unmet medical need by potentially offering both rapid diagnosis and targeted treatment options for concussion patients.
Oragenics (NYSE American: OGEN) ha annunciato una partnership strategica con BRAINBox Solutions per sviluppare la prima terapia intranasale per lesioni cerebrali traumatiche lievi (mTBI) e commozioni cerebrali. La collaborazione combina la piattaforma diagnostica di BRAINBox, che utilizza biomarcatori, valutazioni neuropsicologiche e analisi AI, con il candidato terapeutico di Oragenics ONP-002.
La partnership mira a creare una piattaforma completa per il trattamento. La piattaforma di test di BRAINBox fornisce informazioni diagnostiche e prognostiche, mentre ONP-002, un neurosteroide intranasale terapeutico, ha mostrato promettenti risultati negli studi preclinici per la riduzione degli effetti delle lesioni cerebrali. Gli studi clinici di Fase I hanno dimostrato la tollerabilità e la facilità d'uso di ONP-002.
Con oltre 5 milioni di commozioni cerebrali che si verificano annualmente negli Stati Uniti, questa collaborazione affronta un'importante esigenza medica insoddisfatta, offrendo potenzialmente opzioni di diagnosi rapida e trattamenti mirati per i pazienti con commozione cerebrale.
Oragenics (NYSE American: OGEN) ha anunciado una asociación estratégica con BRAINBox Solutions para desarrollar la primera terapia intranasal para lesiones cerebrales traumáticas leves (mTBI) y conmociones. La colaboración combina la plataforma diagnóstica de BRAINBox, que utiliza biomarcadores, evaluaciones neuropsicológicas y análisis de IA, con el candidato terapéutico de Oragenics ONP-002.
La asociación tiene como objetivo crear una plataforma integral desde el diagnóstico hasta el tratamiento. La plataforma de pruebas de BRAINBox proporciona información diagnóstica y pronóstica, mientras que ONP-002, un neuroesteroide terapéutico intranasal, ha mostrado promesas en estudios preclínicos para la reducción de los efectos de las lesiones cerebrales. Los ensayos clínicos de Fase I demostraron la tolerabilidad y facilidad de uso de ONP-002.
Con más de 5 millones de conmociones cerebrales que ocurren anualmente en EE. UU., esta colaboración aborda una necesidad médica significativa no cubierta, al ofrecer potencialmente opciones de diagnóstico rápido y tratamientos dirigidos para los pacientes con conmoción cerebral.
오라제닉스 (NYSE American: OGEN)는 BRAINBox Solutions와 전략적 파트너십을 체결하여 경미한 외상성 뇌손상(mTBI) 및 뇌진탕에 대한 최초의 비강 치료제를 개발한다고 발표했습니다. 이 협력은 바이오마커, 신경심리 평가 및 AI 분석을 활용하는 BRAINBox의 진단 플랫폼과 오라제닉스의 치료 후보물질 ONP-002를 결합합니다.
이 파트너십은 종합적인 진단-치료 플랫폼을 만드는 것을 목표로 합니다. BRAINBox의 검사 플랫폼은 진단적 및 예후적 통찰력을 제공하며, ONP-002는 비강 신경스테로이드 치료제로서 뇌손상 효과를 줄이는 데 있어 전임상 연구에서 가능성을 보여주었습니다. 1상 임상 시험에서는 ONP-002의 내약성 및 사용 편리성을 입증했습니다.
미국에서 매년 500만 건 이상의 뇌진탕이 발생함에 따라, 이 협력은 뇌진탕 환자에게 빠른 진단 및 표적 치료 옵션을 제공함으로써 중요한 미충족 의료 니즈에 대응하고 있습니다.
Oragenics (NYSE American: OGEN) a annoncé un partenariat stratégique avec BRAINBox Solutions pour développer la première thérapie intranasale pour les lésions cérébrales traumatiques légères (mTBI) et les commotions cérébrales. La collaboration combine la plateforme diagnostique de BRAINBox, qui utilise des biomarqueurs, des évaluations neuropsychologiques et des analyses par IA, avec le candidat thérapeutique d'Oragenics ONP-002.
Ce partenariat vise à créer une plateforme complète de déclenchement à traitement. La plateforme de test de BRAINBox fournit des informations diagnostiques et pronostiques, tandis que ONP-002, un neurostéroïde intranasal thérapeutique, a montré des promesses dans des études précliniques pour réduire les effets des lésions cérébrales. Les essais cliniques de phase I ont démontré la tolérance et la facilité d'utilisation de ONP-002.
Avec plus de 5 millions de commotions cérébrales survenant chaque année aux États-Unis, cette collaboration répond à un besoin médical significatif non satisfait en offrant potentiellement des options de diagnostic rapide et de traitement ciblé pour les patients victimes de commotions cérébrales.
Oragenics (NYSE American: OGEN) hat eine strategische Partnerschaft mit BRAINBox Solutions bekannt gegeben, um die erste intranasale Therapie für leichte traumatische Hirnverletzungen (mTBI) und Gehirnerschütterungen zu entwickeln. Die Zusammenarbeit kombiniert die Diagnosetechnologie von BRAINBox, die Biomarker, neuropsychologische Beurteilungen und KI-Analysen nutzt, mit dem therapeutischen Kandidaten von Oragenics ONP-002.
Ziel der Partnerschaft ist es, eine umfassende Plattform für Diagnose und Behandlung zu schaffen. Die Testplattform von BRAINBox liefert diagnostische und prognostische Einblicke, während ONP-002, ein intranasales Neurosteroid, in vorklinischen Studien vielversprechende Ergebnisse zur Reduzierung der Auswirkungen von Hirnverletzungen gezeigt hat. Die Phase-I-Klinikstudien haben die Verträglichkeit und Benutzerfreundlichkeit von ONP-002 nachgewiesen.
Mit über 5 Millionen Gehirnerschütterungen, die jährlich in den USA auftreten, adressiert diese Zusammenarbeit ein bedeutendes unerfülltes medizinisches Bedürfnis, indem sie potenziell sowohl eine schnelle Diagnose als auch gezielte Behandlungsmöglichkeiten für Patienten mit Gehirnerschütterungen bietet.
- Phase I clinical trial demonstrated ONP-002 was well-tolerated
- Large market opportunity with over 5 million annual concussions in the US
- Strategic partnership combines diagnostic and therapeutic capabilities
- ONP-002 still in early clinical stages with Phase IIa trials pending
- No current revenue generation from the product
Insights
This strategic partnership marks a potentially transformative development in the $2.9 billion traumatic brain injury treatment market. The collaboration creates a unique test-to-treat platform that could address a significant gap in concussion care, where currently no FDA-approved treatments exist.
The technical synergy is particularly noteworthy. BRAINBox's diagnostic platform employs multiple biomarkers and AI analytics, which could significantly enhance patient selection for ONP-002 clinical trials. This precision medicine approach may increase the probability of successful trial outcomes by identifying the most responsive patient populations.
ONP-002's intranasal delivery system represents a important advantage - it enables direct brain access while bypassing the blood-brain barrier, a common challenge in neurological drug development. The successful Phase I results, while preliminary, suggest a favorable safety profile that could expedite development.
However, investors should note several critical factors: 1) The Phase IIa trial timeline remains undefined 2) The competitive landscape includes several companies developing TBI therapeutics, though none with an integrated diagnostic approach 3) The 5 million annual concussions in the U.S. represent a substantial market opportunity, but market penetration will depend on insurance coverage and adoption by sports organizations and healthcare providers.
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The technical integration of BRAINBox's diagnostic platform with Oragenics' intranasal delivery system represents a sophisticated medical device ecosystem. The diagnostic platform's multi-modal approach - combining biomarkers, cognitive assessments and AI analytics - provides a comprehensive assessment tool that could significantly improve patient stratification and treatment monitoring.
The regulatory pathway for this combined platform presents both opportunities and challenges. While the diagnostic component may qualify for the FDA's Breakthrough Device Designation due to its innovative approach to TBI assessment, the integrated nature of the platform might require novel regulatory considerations. The successful Phase I trial of the intranasal device suggests promising usability, but scalable manufacturing and quality control for both components will be crucial.
Market adoption will likely depend on several factors: 1) Ease of integration into existing clinical workflows 2) Training requirements for healthcare providers 3) Cost-effectiveness compared to current diagnostic methods 4) Reimbursement pathways. The platform's ability to provide both diagnostic and therapeutic solutions could accelerate adoption, particularly in sports medicine and emergency care settings.
Collaboration Aims to Develop First Intranasal Therapy for Mild Traumatic Brain Injury Aka Concussion, Establishing a Comprehensive Test-to-Treat Platform
SARASOTA, Fla. and RICHMOND, Va., Feb. 11, 2025 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a biotechnology company advancing innovative treatments for concussion and brain-related health conditions, today announced a strategic partnership with BRAINBox Solutions, a leader in multi-modality diagnostics for traumatic brain injury (TBI). This collaboration seeks to develop the first intranasal therapy for mild traumatic brain injury (mTBI) aka concussion, creating a comprehensive trigger-to-treat platform by combining BRAINBox’s advanced multimarker/ multimodality diagnostic capabilities with Oragenics’ novel therapeutic development.
The partnership intends to integrate BRAINBox’s proprietary diagnostic product platform—which utilizes a combination of neurological biomarkers, neuropsychological assessments, and AI-driven analytics to provide early and accurate TBI assessments—with Oragenics’ intranasal therapeutic candidate, ONP-002. ONP-002 is designed to mitigate the effects of brain injury and promote recovery. Together, these technologies aim to transform the standard of care for concussion patients by providing rapid diagnosis, predictive prognosis, and timely, targeted treatment.
“This collaboration represents a significant step forward in concussion care,” said Janet Huffman, Interim Chief Executive Officer of Oragenics. “By combining our innovative intranasal therapeutic with BRAINBox’s state-of-the-art diagnostic product platform, we hope to offer a comprehensive solution that addresses both the identification and treatment of mTBI, ultimately improving patient outcomes. We believe BRAINBox’s diagnostic tools will be instrumental in our upcoming Phase IIa trials, enabling precise patient selection and real-time monitoring of therapeutic efficacy.”
BRAINBox’s testing platform offers both diagnostic and prognostic insights, identifying patients at higher risk for long-term symptoms and guiding personalized treatment strategies. Oragenics’ ONP-002, an intranasal neurosteroid therapeutic, has demonstrated significant potential in preclinical studies to reduce brain injury effects and support recovery. A Phase I clinical trial showed ONP-002 to be well-tolerated and Oragenics’ novel intranasal device to be easily operated. The integration of these technologies could lead to a seamless trigger-to-treat ecosystem, facilitating early intervention and improving outcomes for millions affected by TBI annually.
Donna Edmonds, Chief Executive Officer of BRAINBox Solutions, added, “Partnering with Oragenics allows us to enhance the impact of our diagnostic technology by linking it directly to a promising therapeutic option. Together, we aim to set a new standard in the management of brain injuries, providing clinicians with the tools they need to deliver timely and effective care.”
With over 5 million concussions occurring annually in the U.S. alone, there is a significant unmet need for effective diagnostic and therapeutic solutions. This partnership positions Oragenics and BRAINBox at the forefront of innovation in TBI care, offering a compelling opportunity for advancing healthcare solutions in neurology.
Investor Contact
Rich Cockrell
404.736.3838
ogen@cg.capital
About Oragenics, Inc.
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 BRAINBox Solutions
BRAINBox Solutions is developing the first AI‐enabled, multi‐modality approach for the diagnosis and prognosis of Mild Traumatic Brain Injury, commonly referred to as a concussion. The company seeks to establish a clinical best‐practice standard for the diagnosis and prognosis of concussion. The product incorporates a panel of proprietary, patented blood biomarkers that can be read in a few moments on a point‐of‐care instrument or using standard laboratory systems, as well as neurocognitive testing, to provide a single‐system score that measures the severity of the injury and post-concussive symptoms. The company is led by key physician and scientific thought leaders in the field and an experienced, clinically focused management team.
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. 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, those described in our Form 10-K and other filings with the U.S. Securities and Exchange Commission. All information set forth in this press release is as of the date hereof. You should consider these factors in evaluating the forward-looking statements included in this press release 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, circumstances should change, except as otherwise required by law.
FAQ
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