Specialty biopharmaceutical company RedHill Biopharma Ltd (Nasdaq:RDHL) announced on Wednesday that it is actively discussing potential collaborations for advancement of its investigational oral drug, opaganib, to combat Ebola virus disease (EVD), including the World Health Organization's (WHO) SOLIDARITY CORE clinical trial platform and pharma collaborations.
According to RedHill, peer-reviewed published data shows that opaganib's host-direction action stems from its ability to simultaneously inhibit three sphingolipid-metabolising 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/TNF-alpha and S1P-mediated vascular permeability (addressing immune dysregulation and vascular leak).
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 Microorganisms.
Proactively, and upon request, RedHill has provided information to relevant government, industry and other organisations, regarding supply readiness and all available clinical and preclinical safety and efficacy data to aid rapid clinical and regulatory discussions.
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.
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