RedHill Announces Publication of Positive Phase 2 Study Results with Once-Daily Oral RHB-107 in Non-Hospitalized COVID-19
January 3, 2023
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Positive data from a U.S. Phase 2 study of once-daily oral RHB-107 (upamostat) in symptomatic COVID-19 published in the peer-reviewed International Journal of Infectious Diseases
RHB-107 successfully met the primary endpoint of safety and tolerability and delivered promising efficacy results, including faster recovery from severe COVID-19 symptoms (median of 3 days to recovery vs. 8 days with placebo) and 100% reduction in hospitalization due to COVID-19
RHB-107, a novel, broad-acting, host-directed, once-daily oral antiviral, is expected to act independently of viral spike protein mutations including Omicron BA.5 sub-variant 
Inclusion of once-daily oral RHB-107 in a multinational platform trial for COVID-19 outpatients pending. Discussions for external non-dilutive funding for additional Phase 3 COVID-19 development advancing
Several collaborative projects, with government and non-government bodies, on a range of preclinical studies against other viral targets for pandemic preparedness ongoing and under discussion
TEL AVIV, Israel and RALEIGH, NC, Jan. 3, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced publication of positive data from a Phase 2 study of once-daily oral investigational RHB-107 (upamostat) in non-hospitalized symptomatic COVID-19 patients, in the peer-reviewed International Journal of Infectious Diseases. The study showed that RHB-107 successfully met the primary endpoint of safety and tolerability and delivered promising efficacy results, despite the small number of patients in each treatment group, including faster recovery from severe COVID-19 symptoms and 100% reduction in hospitalization due to COVID-19.
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Data showed a 100% reduction in hospitalization due to COVID-19, with zero patients (0/41) on the RHB-107 arms versus 15% (3/20) hospitalized on the placebo-controlled arm (nominal p-value=0.0317). The study also showed an approx. 88% reduction in reported new severe COVID-19 symptoms after treatment initiation, with only 2.4% of the RHB-107 treated group (1/41) versus 20% (4/20) of patients in the placebo-controlled arm (nominal p-value=0.036) reporting new severe COVID-19 symptoms. Further analysis showed faster recovery from severe COVID-19 symptoms with a median of 3 days to recovery with upamostat vs. 8 days with placebo.
"It is highly satisfying to see this study, and the exciting results it produced, published in this important journal. These data, achieved despite a small overall sample size, are impressive. Showing both safety and efficacy signals, in a highly convenient once-daily oral therapy, positively positions investigational RHB-107 as a potentially very useful treatment for COVID-19 outpatients to reduce symptom severity and prevent disease progression and hospitalization," said Terry F. Plasse MD, Medical Director at RedHill. "Given the growing awareness of the limitations of existing options for early treatment of COVID-19, it is vital that we do not stop our efforts to bring new options forward – especially those in which we have already observed broad-acting, host-directed variant-agnostic abilities."
The Phase 2 multicenter, randomized, double-blind, placebo-controlled, parallel-group study with once-daily oral RHB-107 in non-hospitalized patients with symptomatic COVID-19 (NCT04723537) evaluated safety and tolerability, provided evidence for dose selection, and provided preliminary assessment of parameters to be used for efficacy evaluation in a Phase 3 study. A total of 61 patients were enrolled and randomized on a 1:1:1 basis to receive one of two dose levels of RHB-107 or a placebo control.
Advanced discussions are ongoing regarding inclusion of once-daily oral RHB-107 in a multinational platform trial for COVID-19 outpatients. Discussions for external non-dilutive funding for Phase 3 COVID-19 development, in addition to the platform study, are also advancing.