– Recruitment completed for Part A of the Phase 2/3 study of once-daily orally-administered RHB-107 (upamostat) for patients with symptomatic COVID-19 who do not require hospital care
– Top-line results for Part A of the study, designed to evaluate safety and tolerability of RHB-107 and dose selection, expected in Q1/ 22
– RHB-107 is a novel, investigational antiviral serine protease inhibitor targeting human cell factors and is expected to be effective against emerging viral variants
– In parallel, data packages for opaganib, RedHill’s other advanced novel oral COVID-19 drug candidate, have been submitted in the U.S., EU, UK and other territories, ahead of planned regulatory advice
TEL AVIV, Israel and RALEIGH, N.C., Nov. 15, 2021 — RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that the last patient has been enrolled in Part A of the Phase 2/3 study with novel, once-daily, orally-administered pill RHB-107 (upamostat)1 for non-hospitalized patients with symptomatic COVID-19. The study is being conducted in the U.S. and South Africa.
The Phase 2/3 study (NCT04723527) with RHB-107 is aimed at evaluating treatment in patients with symptomatic COVID-19 early in the course of the disease, with a once-daily oral treatment that can be prescribed and used in the non-hospitalized patient population. The study is a 2-part, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of RHB-107. The study is designed to evaluate time to sustained recovery from illness as the primary endpoint and for dose selection. A total of 61 patients have been enrolled in Part A and randomized on a 1:1:1 basis to receive one of two doses of upamostat or placebo. Based on safety and tolerability results of part A, a dose for part B will be selected, and patients will be randomized 3:2 to active vs. placebo. Patients are also tested for specific viral strain. Top-line results from Part A of the study are expected in the first quarter of 2022, with Part B of the study expected to follow subsequent to discussions with regulators.
“Once again, we see a rise in COVID-19 infections in many countries across the world – and the need for effective, simple and safe oral therapies that can be used outside the hospital setting, and that can work across COVID-19 variants, is significant,” said Terry F. Plasse MD, Medical Director at RedHill. “Completing randomization for Part A of the RHB-107 Phase 2/3 study is an important step forward for this elegant, once-daily novel oral pill as a potential treatment of COVID-19 in the community.”
RHB-107 is a novel antiviral drug candidate that targets human serine proteases involved in preparing the spike protein for viral entry into target cells. Because it 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 demonstrated strong inhibition of SARS-CoV-2 viral replication in an in vitro human bronchial epithelial cell model. 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.
In parallel, data packages for opaganib2, RedHill’s other advanced novel oral COVID-19 drug candidate – have been submitted to regulators in various territories including the U.S., EU, UK and others, ahead of planned regulatory advice. Opaganib’s global Phase 2/3 study in patients hospitalized with severe COVID-19 demonstrated a 62% reduction in mortality as well as improved outcomes in time to room air and median time to hospital discharge in a sub-group of 251 moderately severe patients, comprising 54% of the study participants.