Opaganib - COVID-19

Opaganib, a first-in-class new chemical entity, is a sphingosine kinase-2 (SK2) selective inhibitor in oral pill form, with proposed 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. RedHill announced top-line data and further analysis from its global 475-patient Phase 2/3 study of oral opaganib in hospitalized patients with severe COVID-19 pneumonia (NCT04467840). Results from prespecified analyses on endpoints of mortality and time to clinical recovery of Phase 2/3 opaganib data were recently released, in addition to previously announced data evaluating median time to viral RNA clearance vs. placebo.

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

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

RedHill previously announced results from preclinical evaluations of opaganib antiviral activity against the original SARS-CoV-2 and variants tested to date in an in vitro model of human lung bronchial tissue. Data from a recent study, which tested opaganib for inhibition of Omicron SARS-CoV-2 viral replication using an ex vivo human respiratory explant model, was also reported in a study conducted by The University of Hong Kong School of Public Health, a world-renowned WHO collaborator center. 

Regulatory submissions and discussions were initiated in the fourth quarter of 2021. Guidance on the confirmatory pivotal study and potential path to approval has been received from the U.S. FDA, UK MHRA, EU’s EMA and additional countries. The pivotal study is under preparation and is planned to be funded by government, external and other non-dilutive sources.

Opaganib is also being investigated for its potential to target multiple other oncology, viral, inflammatory, and gastrointestinal indications.