Grifols Partners with BARDA for Proof-of-Concept Testing of Ocular Immunoglobulin as Treatment for Sulfur Mustard-Induced Eye Injury
Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS) has partnered with BARDA to test ocular surface immunoglobulin (OSIG) eye drops for treating sulfur mustard-induced eye injury. This initiative aims to evaluate the nonclinical efficacy of OSIG in neutralizing symptoms from sulfur mustard exposure, a chemical warfare agent. If successful, it could lead to FDA approval for one of the first medical treatments for sulfur mustard ocular injury.
Grifols is repurposing an investigational OSIG therapeutic currently in development for dry eye disease (DED). The company plans to start a phase 2 clinical trial for DED in the first half of 2025. The research will investigate OSIG's anti-inflammatory properties and its ability to prevent the immune system from attacking self-antigens modified by sulfur mustard exposure.
This partnership follows Grifols' subsidiary GigaGen's recent contract with BARDA, worth up to $135 million, to develop recombinant polyclonal antibody therapies for biothreats including botulinum neurotoxins.
Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS) ha stretto una collaborazione con BARDA per testare le gocce oculari di immunoglobulina della superficie oculare (OSIG) per il trattamento delle lesioni oculari causate dal gas mostarda. Questa iniziativa mira a valutare l'efficacia non clinica dell'OSIG nel neutralizzare i sintomi derivanti dall'esposizione al gas mostarda, un agente di guerra chimica. Se avrà successo, potrebbe portare all'approvazione della FDA per uno dei primi trattamenti medici per le lesioni oculari da gas mostarda.
Grifols sta riadattando un trattamento OSIG sperimentale attualmente in sviluppo per la malattia dell'occhio secco (DED). L'azienda prevede di avviare un trial clinico di fase 2 per la DED nella prima metà del 2025. La ricerca indagherà le proprietà antinfiammatorie dell'OSIG e la sua capacità di prevenire che il sistema immunitario attacchi gli autoantigeni modificati dall'esposizione al gas mostarda.
Questa partnership segue il recente contratto della sussidiaria di Grifols, GigaGen, con BARDA, del valore massimo di 135 milioni di dollari, per sviluppare terapie con anticorpi policlonali ricombinanti per biotipi di minacce, tra cui le neurotossine botuliniche.
Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS) se ha asociado con BARDA para probar gotas oculares de inmunoglobulina de superficie ocular (OSIG) para tratar lesiones oculares inducidas por gas mostaza. Esta iniciativa tiene como objetivo evaluar la eficacia no clínica de OSIG en la neutralización de los síntomas por exposición al gas mostaza, un agente de guerra química. Si tiene éxito, podría llevar a la aprobación de la FDA para uno de los primeros tratamientos médicos para lesiones oculares por gas mostaza.
Grifols está reutilizando un tratamiento OSIG en investigación que actualmente se encuentra en desarrollo para la enfermedad del ojo seco (DED). La compañía planea iniciar un ensayo clínico de fase 2 para DED en la primera mitad de 2025. La investigación investigará las propiedades antiinflamatorias de OSIG y su capacidad para prevenir que el sistema inmunológico ataque autoantígenos modificados por la exposición al gas mostaza.
Esta asociación sigue al reciente contrato de la subsidiaria de Grifols, GigaGen, con BARDA, por un valor de hasta 135 millones de dólares, para desarrollar terapias con anticuerpos policlonales recombinantes para amenazas biológicas, incluidos los neurotoxinas botulínicas.
그리폴스 (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS)는 바르다(BARDA)와 협력하여 안구 표면 면역 글로불린 (OSIG) 점안액을 황화물 핀란드가 유발한 안구 손상 치료를 위해 시험하고 있습니다. 이 이니셔티브는 황화물 핀란드 노출로 인한 증상의 중화에서 OSIG의 비임상 효능을 평가하는 것을 목표로 하고 있습니다. 성공할 경우, 이는 황화물 핀란드 안구 손상을 위한 최초의 의학적 치료 중 하나에 대한 FDA 승인으로 이어질 수 있습니다.
그리폴스는 건조 눈 질환 (DED)을 위한 개발 중인 실험적 OSIG 치료제를 재활용하고 있습니다. 회사는 2025년 상반기에 DED에 대한 2상 임상 시험을 시작할 계획입니다. 이 연구는 OSIG의 항염증 속성과 면역계가 황화물 핀란드 노출로 수정된 자기 항원을 공격하지 못하도록 하는 능력을 조사할 것입니다.
이번 파트너십은 그리폴스의 자회사 기가젠(GigaGen)이 바르다와 최근 체결한 최대 1억 3천5백만 달러 규모의 계약에 따라 생물 위협을 위한 재조합 다클론 항체 요법을 개발하는 것을 따릅니다.
Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS) s'est associé à BARDA pour tester des gouttes oculaires d'immunoglobuline de surface oculaire (OSIG) pour traiter les lésions oculaires causées par le moutarde. Cette initiative vise à évaluer l'efficacité non clinique de l'OSIG dans la neutralisation des symptômes d'exposition au moutarde, un agent de guerre chimique. Si cela réussit, cela pourrait conduire à l'approbation de la FDA pour l'un des premiers traitements médicaux des lésions oculaires causées par le moutarde.
Grifols réutilise un traitement OSIG expérimental actuellement en développement pour la maladie de l'œil sec (DED). L'entreprise prévoit de commencer un essai clinique de phase 2 pour DED dans la première moitié de 2025. La recherche examinera les propriétés anti-inflammatoires de l'OSIG et sa capacité à empêcher le système immunitaire d'attaquer les auto-antigènes modifiés par l'exposition au moutarde.
Ce partenariat fait suite au récent contrat de la filiale de Grifols, GigaGen, avec BARDA, d'une valeur allant jusqu'à 135 millions de dollars, pour développer des thérapies à base d'anticorps polyclonaux recombinants pour des menaces biologiques, y compris les neurotoxines botuliques.
Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS) hat sich mit BARDA zusammengetan, um Augentropfen mit okulären Oberflächenimmunglobulinen (OSIG) zur Behandlung von Augenschäden durch Senfgas zu testen. Diese Initiative zielt darauf ab, die nicht-klinische Wirksamkeit von OSIG bei der Neutralisierung von Symptomen durch Senfgasexposition, einem chemischen Kampfstoff, zu bewerten. Wenn erfolgreich, könnte dies zur FDA-Zulassung für eine der ersten medizinischen Behandlungen von Senfgasbedingten Augenverletzungen führen.
Grifols bereitet ein experimentelles OSIG auf, das derzeit zur Behandlung von trockenem Auge (DED) in Entwicklung ist. Das Unternehmen plant, in der ersten Hälfte von 2025 eine Phase-2-Klinikstudie für DED zu starten. Die Forschung wird die entzündungshemmenden Eigenschaften von OSIG und seine Fähigkeit untersuchen, das Immunsystem daran zu hindern, durch Senfgasexposition modifizierte Eigenantigene anzugreifen.
Diese Partnerschaft folgt dem kürzlich geschlossenen Vertrag der Tochtergesellschaft von Grifols, GigaGen, mit BARDA, der bis zu 135 Millionen Dollar wert ist, um rekombinante polyklonale Antikörpertherapien für biologische Bedrohungen, einschließlich Botulinumneurotoxinen, zu entwickeln.
- Potential development of one of the first medical treatments for sulfur mustard ocular injury
- Planned phase 2 clinical trial for dry eye disease treatment in first half of 2025
- Expansion of innovation pipeline in ocular treatments
- Recent $135 million contract with BARDA for biodefense therapies
- OSIG eye drops are still in preclinical stage for sulfur mustard injury treatment
- Success of the treatment is not guaranteed and depends on clinical trial results
Insights
This partnership between Grifols and BARDA represents a significant step in developing treatments for chemical warfare injuries. The focus on repurposing ocular surface immunoglobulin (OSIG) for sulfur mustard exposure demonstrates innovative thinking in addressing an unmet medical need.
Key points to consider:
- Potential to be one of the first FDA-licensed treatments for sulfur mustard ocular injury
- Leverages Grifols' expertise in immunoglobulins
- Dual-purpose development: treating both chemical warfare injuries and dry eye disease
- Aligns with Grifols' strategy to expand its innovation pipeline
While this news is promising, investors should note that the project is still in early stages. Success in preclinical studies doesn't guarantee FDA approval or commercial viability. However, the BARDA partnership and potential government contracts could provide significant revenue streams if successful.
This partnership has several positive financial implications for Grifols:
- Diversification of revenue streams through government contracts
- Potential for high-margin products in both military and civilian markets
- Reduced R&D costs through BARDA funding
- Enhanced market position in the growing ophthalmology sector
The dry eye disease market alone is projected to reach
Investors should monitor the progress of both the OSIG for sulfur mustard injury and the dry eye disease clinical trials, as success in either could significantly impact Grifols' future earnings. The company's focus on innovation and expanding its product pipeline is a positive sign for long-term growth prospects.
- Initiative will test Grifols ocular surface immunoglobulin (OSIG) eye drops to evaluate their nonclinical efficacy in neutralizing symptoms from exposure to sulfur mustard, a chemical warfare agent
- A successful preclinical study of this potentially innovative therapeutic could lead to an FDA license for one of the first medical treatments for sulfur mustard ocular injury
- Grifols also plans to start a phase 2 clinical trial of an OSIG for dry eye disease in the first half of 2025, part of the company’s broadening innovation pipeline to enhance the lives of patients
BARCELONA, Spain, Oct. 22, 2024 (GLOBE NEWSWIRE) -- Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global healthcare company and leading manufacturer of plasma-derived medicines, today announced it has established a partnership with the Biomedical Advanced Research and Development Authority (BARDA) to test investigational ocular surface immunoglobulin (OSIG) eye drops for their ability to treat ocular damage from sulfur mustard exposure. BARDA is part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS).
If the preclinical evaluation is successful, the United States Food and Drug Administration (FDA) could eventually license what would be one of the first medical treatments to counteract the long-term effects of sulfur mustard ocular injury. Sulfur mustard, sometimes referred to as mustard gas, is a chemical warfare agent that reacts rapidly with ocular tissue and can cause pain, photophobia and mustard gas keratopathy, a corneal injury that can lead to blindness.
Grifols will develop a treatment for sulfur mustard ocular exposure by repurposing an investigational OSIG therapeutic currently in development for dry eye disease (DED). The nonclinical studies, conducted in partnership with BARDA, may provide evidence for the anti-inflammatory and immunomodulatory properties of OSIG and its ability to alleviate the long-term effects of sulfur mustard exposure.
Specifically, research will investigate how OSIG’s anti-inflammatory properties can prevent the immune system from mistakenly attacking self-antigens, which in this case are proteins modified due to exposure to sulfur mustard. In cases of sulfur mustard exposure, the immune system can errantly target these self-antigens. By neutralizing the immune response caused by the self-antigens, OSIG could help protect ocular tissue and support recovery in people exposed to sulfur mustard.
Grifols announced in March 2023 a collaboration with Chicago-based Selagine, which focuses on developing novel therapeutics for ocular diseases, to treat DED with immunoglobulin eye drops. The potential treatment, expected to enter clinical development in the first half of 2025, would become the first immunoglobulin medicine indicated for DED, which affects more than 100 million people globally.
“Grifols is applying its leadership in immunoglobulins, a powerful class of medicines with a unique mechanism of action, to develop safe, effective and readily available IG-based ocular treatments to alleviate conditions that seriously impact people’s eyesight and quality of life,” said Joerg Schuettrumpf, Grifols Chief Scientific Innovation Officer. “We continue to build an innovation pipeline focused on providing more and better treatments for patients.”
Grifols’ work with BARDA to create an OSIG to neutralize the effects of sulfur mustard ocular exposure comes shortly after the company’s GigaGen subsidiary announced a contract with BARDA, worth up to
This project has been supported in whole or in part with federal funds from the HHS, ASPR and BARDA under contract number 75A50124C00050.
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About Grifols
Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people around the world. A leader in essential plasma-derived medicines and transfusion medicine, the company develops, produces, and provides innovative healthcare services and solutions in more than 110 countries.
Patient needs and Grifols’ ever-growing knowledge of many chronic, rare and prevalent conditions, at times life-threatening, drive the company’s innovation in both plasma and other biopharmaceuticals. Grifols is focused on treating conditions across a broad range of therapeutic areas: immunology, hepatology and intensive care, pulmonology, hematology, neurology, and infectious diseases.
A pioneer in the plasma industry, Grifols continues to grow its network of donation centers, the world’s largest with over 390 across North America, Europe, Africa and the Middle East, and China.
As a recognized leader in transfusion medicine, Grifols offers a comprehensive portfolio of solutions designed to enhance safety from donation to transfusion, in addition to clinical diagnostic technologies. It provides high-quality biological supplies for life-science research, clinical trials, and for manufacturing pharmaceutical and diagnostic products. The company also supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care.
Grifols, with more than 23,000 employees in more than 30 countries and regions, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety, and ethical leadership.
The company’s class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS).
For more information about Grifols, please visit grifols.com
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The facts and figures contained in this report that do not refer to historical data are “future projections and assumptions”. Words and expressions such as “believe”, “hope”, “anticipate”, “predict”, “expect”, “intend”, “should”, “will seek to achieve”, “it is estimated”, “future” and similar expressions, in so far as they relate to the Grifols group, are used to identify future projections and assumptions. These expressions reflect the assumptions, hypotheses, expectations and predictions of the management team at the time of writing this report, and these are subject to a number of factors that mean that the actual results may be materially different. The future results of the Grifols group could be affected by events relating to its own activities, such as a shortage of supplies of raw materials for the manufacture of its products, the appearance of competitor products on the market, or changes to the regulatory framework of the markets in which it operates, among others. At the date of compiling this report, the Grifols group has adopted the necessary measures to mitigate the potential impact of these events. Grifols, S.A. does not accept any obligation to publicly report, revise or update future projections or assumptions to adapt them to events or circumstances subsequent to the date of writing this report, except where expressly required by the applicable legislation. This document does not constitute an offer or invitation to buy or subscribe shares in accordance with the provisions of the following Spanish legislation: Royal Legislative Decree 4/2015, of 23 October, approving recast text of Securities Market Law; Royal Decree Law 5/2005, of 11 March and/or Royal Decree 1310/2005, of 4 November, and any regulations developing this legislation. In addition, this document does not constitute an offer of purchase, sale or exchange, or a request for an offer of purchase, sale or exchange of securities, or a request for any vote or approval in any other jurisdiction. The information included in this document has not been verified nor reviewed by the external auditors of the Grifols group.
FAQ
What is Grifols (GRFS) testing with BARDA for sulfur mustard-induced eye injury?
When does Grifols (GRFS) plan to start a phase 2 clinical trial for dry eye disease?
What recent contract did Grifols' subsidiary GigaGen secure with BARDA?
What is the potential impact of Grifols' (GRFS) OSIG eye drops for sulfur mustard injury?
