RedHill Selected to Present Opaganib at Conference Organized by U.S. Government's JPEO-CBRND
RedHill Biopharma (Nasdaq: RDHL) has been selected to present its drug opaganib at the JPEO-CBRND's 'Host Directed Therapeutics Industry Day' on October 29-30, 2024, in Alexandria, VA. The selection was based on the drug's demonstrated capabilities in prophylaxis and treatment of exposure to viruses, bacteria, and toxins.
The JPEO-CBRND, which manages U.S. government investments in chemical, biological, radiological, and nuclear defense equipment and medical countermeasures, will host the presentation. Opaganib, a novel host-directed oral drug, is being developed for various applications including oncology, viral infections, inflammatory diseases, and chemical/nuclear protection, with multiple ongoing U.S. government collaborations.
RedHill Biopharma (Nasdaq: RDHL) è stata selezionata per presentare il suo farmaco opaganib durante la 'Giornata dell'Industria delle Terapie Dirette agli Ospiti' del JPEO-CBRND, che si terrà il 29-30 ottobre 2024 ad Alexandria, VA. La selezione è stata basata sulle dimostrate capacità del farmaco nella profilassi e nel trattamento dell'esposizione a virus, batteri e tossine.
Il JPEO-CBRND, che gestisce gli investimenti del governo degli Stati Uniti in equipaggiamenti di difesa chimica, biologica, radiologica e nucleare, nonché in contro-misure mediche, ospiterà la presentazione. Opaganib, un innovativo farmaco orale diretto all'ospite, è in fase di sviluppo per vari utilizzi, tra cui oncologia, infezioni virali, malattie infiammatorie e protezione chimica/nucleare, con diverse collaborazioni in corso con il governo degli Stati Uniti.
RedHill Biopharma (Nasdaq: RDHL) ha sido seleccionada para presentar su medicamento opaganib en el 'Día de la Industria de terapias dirigidas a hospedadores' del JPEO-CBRND, que se llevará a cabo del 29 al 30 de octubre de 2024 en Alexandria, VA. La selección se basó en las capacidades demostradas del fármaco en la profilaxis y tratamiento de la exposición a virus, bacterias y toxinas.
El JPEO-CBRND, que gestiona las inversiones del gobierno de EE. UU. en equipos de defensa química, biológica, radiológica y nuclear, así como en medidas médicas de respuesta, será el anfitrión de la presentación. Opaganib, un novedoso medicamento oral dirigido al hospedador, se está desarrollando para diversas aplicaciones, incluyendo oncología, infecciones virales, enfermedades inflamatorias y protección química/nuclear, con múltiples colaboraciones en curso con el gobierno de EE. UU.
RedHill Biopharma (Nasdaq: RDHL)는 2024년 10월 29일부터 30일까지 버지니아주 알렉산드리아에서 열리는 JPEO-CBRND의 '숙주 지향 치료제 산업의 날'에서 자신의 약물 opaganib를 발표하기 위해 선정되었습니다. 이 선정은 바이러스, 박테리아 및 독소 노출에 대한 예방 및 치료에서 약물의 입증된 능력에 기반하였습니다.
JPEO-CBRND는 미국 정부의 화학, 생물학, 방사선 및 핵 방어 장비 및 의료 대응 수단에 대한 투자를 관리하며, 발표를 주최할 예정입니다. 오파가닙은 숙주 지향의 혁신적인 경구 약물로, 종양학, 바이러스 감염, 염증성 질환 및 화학/핵 보호를 포함한 다양한 용도로 개발되고 있으며, 여러 미국 정부 협력 프로젝트가 진행 중입니다.
RedHill Biopharma (Nasdaq: RDHL) a été sélectionnée pour présenter son médicament opaganib lors de la 'Journée de l'Industrie des Thérapies Dirigées vers l'Hôte' du JPEO-CBRND qui se tiendra les 29 et 30 octobre 2024 à Alexandria, VA. Cette sélection s'est basée sur les capacités démontrées du médicament dans la prophylaxie et le traitement de l'exposition aux virus, bactéries et toxines.
Le JPEO-CBRND, qui gère les investissements du gouvernement américain dans les équipements de défense chimique, biologique, radiologique et nucléaire, ainsi que dans les contre-mesures médicales, sera l'hôte de la présentation. L'opaganib, un médicament oral innovant dirigé vers l'hôte, est développé pour diverses applications, y compris l'oncologie, les infections virales, les maladies inflammatoires et la protection chimique/nucléaire, avec plusieurs collaborations en cours avec le gouvernement américain.
RedHill Biopharma (Nasdaq: RDHL) wurde ausgewählt, um sein Medikament opaganib am 'Tag der Industrie für wirtgerichtete Therapien' des JPEO-CBRND am 29. und 30. Oktober 2024 in Alexandria, VA, zu präsentieren. Die Auswahl basierte auf den nachgewiesenen Fähigkeiten des Medikaments zur Prophylaxe und Behandlung von Exposition gegenüber Viren, Bakterien und Toxinen.
Das JPEO-CBRND, das die Investitionen der US-Regierung in chemische, biologische, radiologische und nukleare Verteidigungsgeräte sowie in medizinische Gegenmaßnahmen verwaltet, wird die Präsentation ausrichten. Opaganib, ein neuartiges oral verabreichbares Medikament, wird für verschiedene Anwendungen entwickelt, darunter Onkologie, Virusinfektionen, entzündliche Erkrankungen und chemische/nukleare Schutzmaßnahmen, mit mehreren laufenden Kooperationen mit der US-Regierung.
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Based on reviews, feedback, and discussion, the judges selected for presentation those therapeutics that demonstrated capability in the prophylaxis, post-exposure prophylaxis, and the treatment of exposure to viruses, bacteria and toxins. The meeting is scheduled to take place October 29-30, 2024, at the United States Patent and Trademark Office in
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The JPEO-CBRND manages
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With multiple
The JPEO-CBRND manages
"Opaganib is already the subject of multiple ongoing collaborations with several
About Opaganib (ABC294640)
Opaganib, a proprietary investigational host-directed and potentially broad-acting drug, is a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple potential indications, including several cancers, diabetes and obesity-related disorders, gastrointestinal acute radiation syndrome (GI-ARS), Sulfur Mustard exposure, COVID-19, Ebola and other viruses as part of pandemic preparedness.
Opaganib's host-directed action is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS).
Several
Opaganib has demonstrated antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A and Ebola. Opaganib delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day (BID) in a United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in vivo Ebola virus study, making it the first host-directed molecule to show activity in Ebola virus disease. Opaganib also recently demonstrated a distinct synergistic effect when combined individually with remdesivir (Veklury®, Gilead Sciences Inc.), significantly improving potency while maintaining cell viability, in a
Being host-targeted, and based on data accumulated to date, opaganib is expected to maintain effect against emerging viral variants. In prespecified analyses of Phase 2/3 clinical data in hospitalized patients with moderate to severe COVID-19, oral opaganib demonstrated improved viral RNA clearance, faster time to recovery and significant mortality reduction in key patient subpopulations versus placebo on top of standard of care. Opaganib has demonstrated its safety and tolerability profile in more than 470 people in multiple clinical studies and expanded access use. Data from the opaganib global Phase 2/3 study was published in Microorganisms.
Opaganib has received several orphan-drug designations from the FDA in oncology and other diseases and has undergone studies in advanced cholangiocarcinoma (Phase 2a) and prostate cancer. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission.
Opaganib has also shown positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, radioprotection, viral, inflammatory, and gastrointestinal indications.
Disclaimer: The views and opinions of authors expressed herein do not necessarily state or reflect those of the
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases.
More information about the Company is available at www.redhillbio.com / X.com/RedHillBio.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include, among others, statements regarding the potential of opaganib. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: market and other conditions; the Company's ability to maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that acceptance onto the RNCP Product Development Pipeline will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for opaganib for any indication; the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials; the risk that the FDA pre-study requirements will not be met and/or that the Phase 3 study of RHB-107 in COVID-19 outpatients will not be approved to commence or if approved, will not be completed or, should that be the case, that we will not be successful in obtaining alternative non-dilutive development funding for RHB-107; the risk that RHB-107's late-stage development for non-hospitalized COVID-19 will not benefit from the resources redirected from the terminated RHB-204 Phase 3 study, and that the Phase 2/3 COVID-19 study for RHB-107 may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib and RHB-107 are likely to be required; the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the
Company contact: Adi Frish |
Category: R&D
[1]Opaganib is an investigational new drug, not available for commercial distribution.
[2]Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com.
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SOURCE RedHill Biopharma Ltd.
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