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 (upamostat) has also been accepted for inclusion in the Austere environments Consortium for Enhanced Sepsis Outcomes’(ACESO) U.S. Government-supported PROTECT multinational platform trial for early COVID-19 outpatient treatment to be conducted in the U.S., Thailand, Ivory Coast and South Africa. The Company also announced that the 300-patient Phase 2 study, predominantly funded by the U.S. Government’s Joint Program Executive Office (JPEO) for Chemical, Biological, Radiological and Nuclear Defense, has received FDA clearance to start and is estimated to be completed by end of 2024.