RHB-107, an investigational drug, is a proprietary, first-in-class, novel once-daily, orally-administered potent inhibitor of several serine proteases, with antiviral and potential tissue-protective effects.
RedHill previously announced results from preclinical evaluations of RHB-107 against the original SARS-CoV-2 in an in vitro model of human lung bronchial tissue.
Serine proteases are involved in preparing the viral spike protein for viral entry into target cells. Because its mechanism of action is host-cell targeted, RHB-107 is expected to also be effective against emerging viral variants with mutations in the spike protein.
RHB-107 has a strong clinical safety and biodistribution profile, demonstrated in previous clinical studies, including several Phase 1 and Phase 2 studies in different indications, in approximately 200 patients.
RHB-107 is being evaluated in a Phase 2/3 study in the U.S. and South Africa for the treatment of non-hospitalized patients with symptomatic COVID-19 early in the course of the disease, who do not require supplemental oxygen. The study is a 2-part, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. RedHill recently announced positive results from Part A of the Phase 2/3 study in which the primary endpoint of favorable safety and tolerability was met, and demonstrating promising preliminary efficacy findings of RHB-107 in non-hospitalized COVID-19 patients.
The Phase 2/3 clinical study with RHB-107 in COVID-19 is registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.