RedHill Selected to Present Opaganib at Conference Organized by U.S. Government's JPEO-CBRND

Core Viewpoint - RedHill Biopharma has been selected to present opaganib's potential to U.S. government representatives at the JPEO-CBRND "Host Directed Therapeutics Industry Day" scheduled for October 29-30, 2024, highlighting its capabilities in treating viral, bacterial, and toxin exposures [1][3]. Group 1: Opaganib Overview - Opaganib is a novel, host-directed, orally administered small molecule drug with demonstrated safety and efficacy, being developed for various indications including oncology, viral infections, inflammatory diseases, and chemical and nuclear/radioprotection [1][4]. - It is a first-in-class sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory, and antiviral activity, targeting multiple potential indications such as cancers, COVID-19, and Ebola [4][9]. Group 2: Government Collaboration and Evaluation - Opaganib has been selected for evaluation in several U.S. government countermeasures and pandemic preparedness programs, including those led by NIAID and BARDA [6]. - The JPEO-CBRND manages U.S. government investments in CBRN defense and has selected therapeutics that demonstrate capability in prophylaxis and treatment of exposures to various pathogens [2]. Group 3: Clinical Efficacy and Research Findings - Opaganib has shown antiviral activity against SARS-CoV-2 and other viruses, with significant increases in survival time in Ebola studies and improved outcomes in COVID-19 patients [7][8]. - In Phase 2/3 clinical trials, opaganib demonstrated improved viral RNA clearance and reduced mortality in hospitalized COVID-19 patients compared to placebo [8]. Group 4: Future Development and Designations - Opaganib has received orphan-drug designations from the FDA and has ongoing studies in advanced cholangiocarcinoma and prostate cancer, with a Phase 1 study protocol ready for FDA-IND submission [9]. - The drug is expected to maintain efficacy against emerging viral variants based on its host-targeted mechanism [8].