RedHill has two novel proprietary investigational drugs in development for the treatment of different stages of COVID-19 - opaganib and RHB-107:

Opaganib – Phase 2/3-Stage

Opaganib (ABC294640) is a first-in-class, twice-daily, oral, host-directed antiviral sphingosine kinase-2 (SPHK2) selective inhibitor that is potentially broad-acting.

Opaganib is in development for the treatment of hospitalized patients with moderate to severe COVID-19, as well as other viral, inflammatory, gastrointestinal and oncological diseases.

Opaganib has completed a 463-patient global Phase 2/3 study in hospitalized patients with severe COVID-19 pneumonia (NCT04467840). Despite not meeting the study’s primary endpoint, several efficacy trends in key patient sub-groups were achieved. 

RedHill announced data from the prespecified analyses of all Phase 2/3 study patients, which showed improvements compared to the control arm with respect to median time to viral RNA clearance. In addition, RedHill announced positive data, which was also published in medRxiv from a post-hoc analysis in a subset of moderately severe COVID-19 patients evaluating clinical parameters including mortality, time to discharge and time to recovery. Overall adverse events were balanced between the opaganib and placebo groups.

Prior to that, RedHill announced top-line safety and efficacy data from a U.S. Phase 2 study of opaganib in December 2020, published in Open Forum Infectious Diseases.

RHB-107- Phase 2-Stage

RHB-107 (INN: upamostat) is a first-in-class, once-daily, oral antiviral that is a potent inhibitor of serine proteases.

RHB-107 is in development for the treatment of non-hospitalized symptomatic COVID-19 patients, as well as other viral, oncological and gastrointestinal diseases. 

RHB-107 has completed a Phase 2 study in non-hospitalized symptomatic COVID-19 patients evaluating the safety and tolerability profile of RHB-107 and efficacy signals (NCT04723537). The study’s positive results have been published in the peer-reviewed International Journal of Infectious Diseases.

RHB-107 has also been accepted for inclusion in the Austere environments Consortium for Enhanced Sepsis Outcomes’ (ACESO) U.S. Government-supported PROTECT platform trial for early COVID-19 outpatient treatment (NCT05954286). RedHill announced that the 300-patient Phase 2 study, which received FDA clearance to start is to be conducted in the U.S., Thailand, Ivory Coast, South Africa and Uganda. The study is predominantly funded by the U.S. Government Department of Defense's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND). More recently, RedHill announced new non-dilutive external funding, which now covers the entirety of the RHB-107 arm of the ACESO PROTECT adaptive platform trial for early COVID-19 outpatient treatment. The new funding amounts to approximately $4.8M directed toward the evaluation of RHB-107 in the study, in addition to the previously announced U.S. Government non-dilutive funding.