RedHill Biopharma announced collaborations with two specialist pharmaceutical manufacturers in Europe and Canada to ramp-up manufacturing of opaganib, currently in global Phase 2/3 and U.S. Phase 2 studies for severe COVID-19 pneumonia.
“In light of the rapid progress of our Phase 2/3 COVID-19 development program with opaganib, we are expanding manufacturing capabilities and capacity for opaganib with trusted and high-quality partners, to meet likely demand ahead of potential global emergency use applications,” said Reza Fathi, PhD., RedHill’s Senior VP, R&D.
Opaganib is a first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component, potentially minimizing the likelihood of viral resistance.
The late-stage development program for opaganib in patients with severe COVID-19 pneumonia includes: The U.S. Phase 2 study (NCT04414618), ongoing in eight clinical trial sites, is approaching completion of enrollment, and recently passed a second independent committee review, with data expected to follow before the end of this year; and the global Phase 2/3 study (NCT04467840), which is enrolling rapidly across 15 study sites and is on track to enroll up to 270 patients by the end of the year. Both studies are randomized, double-blind, parallel-arm, placebo-controlled trials with opaganib in patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen.
Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue.
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The Company is in discussions with U.S. government agencies around potential funding to support the rapid advancement of opaganib toward potential emergency use applications and manufacturing scale-up.
Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component, potentially minimizing the likelihood of viral resistance. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.
Opaganib received Orphan Drug designation from the U.S. Food & Drug Administration (FDA) for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Opaganib is also being evaluated in a global Phase 2/3 study and a U.S. Phase 2 study for the treatment of COVID-19.
Preclinical data have demonstrated both anti-inflammatory and antiviral activities of opaganib, with the potential to reduce inflammatory lung disorders, such as pneumonia, and mitigate pulmonary fibrotic damage. Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies1 have demonstrated that opaganib decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids.
Under a compassionate use program, COVID-19 patients (as classified by the WHO ordinal scale) were treated with opaganib in a leading hospital in Israel. Data from the treatment of these first patients with severe COVID-19 with opaganib have been published2. Analysis of treatment outcomes suggested substantial benefit to patients treated with opaganib under compassionate use in both clinical outcomes and inflammatory markers as compared to a retrospective matched case-control group from the same hospital. All patients in the opaganib-treated group were discharged from hospital on room air without requiring intubation and mechanical ventilation, whereas 33% of the matched case-control group required intubation and mechanical ventilation. Median time to weaning from high-flow nasal cannula was reduced to 10 days in the opaganib-treated group, as compared to 15 days in the matched case-control group.