TEL AVIV, Israel and RALEIGH, N.C., June 3, 2026 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it is actively discussing potential collaborations for advancement of its investigational oral drug, opaganib, to combat EVD, which can be fatal in approximately half of all cases, including the World Health Organization's (WHO) SOLIDARITY CORE clinical trial platform and pharma collaborations.
"Opaganib sits in a distinct category as a host-directed agent which can be added to direct-acting antivirals, representing an opportunity to enhance global infectious disease preparedness and biodefense infrastructure against EVD, while also being preferentially suited to the logistical challenges found on the ground during these tragic outbreaks."
Peer-reviewed data shows opaganib's host-direction action stems from its ability to simultaneously inhibit three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS), altering the cellular lipid balance and enabling inhibition of replication of viruses like SARS-CoV-2 and Ebola. In EVD specifically, opaganib offers a potential dual mechanism of action; blocking the PI3K/Akt pathway critical for filovirus entry and suppressing NLRP3 inflammasome and reducing IL-6/TNFα and S1P-mediated vascular permeability (addressing immune dysregulation and vascular leak).
Proactively, and upon request, the Company has provided information to relevant government, industry and other organizations, regarding supply readiness and all available clinical and preclinical safety and efficacy data to aid rapid clinical and regulatory discussions.
Opaganib has demonstrated its safety and tolerability profile in more than 470 participants in multiple clinical studies and expanded access use, including a large global Phase 2/3 study in hospitalized patients with moderate to severe COVID-19, published in . Opaganib is an investigational new drug. It has not been approved by any regulatory authority and is not available for commercial distribution. Inclusion in the WHO CORE platform cannot be guaranteed.
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology.
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Adi FrishChief Corporate & Business Development OfficerRedHill Biopharma
Category: R&D
Opaganib is an investigational new drug, not available for commercial distribution.
Neuenschwander FC, Barnett-Griness O, Piconi S, Maor Y, Sprinz E, Assy N, Khmelnitskiy O, Lomakin NV, Goloshchekin BM, Nahorecka E, et al. Effect of Opaganib on Supplemental Oxygen and Mortality in Patients with Severe SARS-CoV-2 Based upon FIO2 Requirements. Microorganisms. 2024; 12(9):1767.
Antiviral Activity of Opaganib, a First-in-class Sphingolipid Modulator. Rekha G. Panchal1*, Raina Kumar1, Eric Nguyen1#, LTC Jeffrey Kugelman1, Janet Skerry1, Xiaoli Chi1, Ashley Mcaleese1#, Aura R. Garrison, Mark Levitt, Gilead Raday, Patricia Anderson, Sara Johnston, Reza Fathi, LTC Robert Haupt United States Army Medical Research Institute of Infectious Diseases
Repeat study showed 20% vehicle survival vs. 10% opaganib; mixed results across the two animal models (including the vehicle only group inter study variability) underscore model variability.
Sphingosine Kinases Promote Ebola Virus Infection and Can Be Targeted to Inhibit Filoviruses, Coronaviruses, and Arenaviruses Using Late Endocytic Trafficking to Enter Cells. Corina M. Stewart, Yuxia Bo, Kathy Fu, Mable Chan, Robert Kozak, Kim Yang-Ping Apperley, Geneviève Laroche, Redaet Daniel, André M. Beauchemin, Gary Kobinger, Darwyn Kobasa, and Marceline Côté. ACS Infectious Diseases 2023 9 (5), 1064-1077. DOI: 10.1021/acsinfecdis.2c00416
Sphingosine Kinases Promote Ebola Virus Infection and Can Be Targeted to Inhibit Filoviruses, Coronaviruses, and Arenaviruses Using Late Endocytic Trafficking to Enter Cells. Corina M. Stewart, Yuxia Bo, Kathy Fu, Mable Chan, Robert Kozak, Kim Yang-Ping Apperley, Geneviève Laroche, Redaet Daniel, André M. Beauchemin, Gary Kobinger, Darwyn Kobasa, and Marceline Côté. ACS Infectious Diseases 2023 9 (5), 1064-1077. DOI: 10.1021/acsinfecdis.2c00416
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