Opaganib - COVID-19

Opaganib, a first-in-class new chemical entity, is a sphingosine kinase-2 (SK2) selective inhibitor in oral pill form, with dual anti-inflammatory and antiviral activity. Opaganib’s unique mechanism is host-targeted and therefore expected to be effective against emerging viral variants.

Opaganib is an investigational drug being evaluated as a treatment for severe COVID-19 pneumonia in a global 475-patient Phase 2/3 study (NCT04467840), that has recently completed all patient treatment and follow up, with top-line results expected soon.

RedHill previously announced positive safety and efficacy data from a 40-patient U.S. Phase 2 study with opaganib, which evaluated improvement in reducing of oxygen requirement by end of treatment on Day 14, on top of standard-of-care, as well as other safety and efficacy endpoints.

Additionally, positive compassionate use of opaganib in Israel has been published in the peer-reviewed Journal of Emerging Diseases and Virology.

Opaganib

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. Opaganib has also demonstrated strong inhibition against variants of concern, including Delta.  Additionally, preclinical in vivo studies have demonstrated opaganib’s potential to ameliorate inflammatory lung disorders, such as pneumonia, and has shown 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.

Opaganib also targets multiple oncology, viral, inflammatory, and gastrointestinal indications.