The South African Health Products Regulatory Authority (SAHPRA) has approved 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

Number of U.S. sites for the study has also been expanded

RHB-107, a novel antiviral serine protease inhibitor targeting human cell factors, is expected to be effective against emerging viral variants

RHB-107 is being developed as a potential treatment with a simple once-daily oral pill in the early course of COVID-19

In parallel RedHill's leading oral COVID-19 therapeutic, opaganib, is being evaluated in a global Phase 2/3 study in 475 patients hospitalized with severe COVID-19, with top-line results upcoming

TEL AVIV, Israel and RALEIGH, N.C., Sept. 13, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that South Africa has joined the U.S. in approving 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 already ongoing in the U.S., with expansion of study sites underway to further accelerate recruitment.

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.

"South Africa continues to face an onslaught of COVID-19 that is claiming many lives and causing significant distress to the healthcare system. South Africa, along with the U.S. and rest of the world, urgently need the ability to easily and effectively treat COVID-19 and its variants, both inside and outside the hospital setting," said Terry F. Plasse MD, Medical Director at RedHill. "As clearly highlighted recently by the Director of NIAID, it is important to be able to treat patients early in the course of the disease to prevent progression to more severe symptoms. The approval of this study in South Africa, along with the expansion of study sites in the U.S., are aimed at accelerating our efforts to bring RedHill's two novel, oral compounds that cover the spectrum of COVID-19 disease severity, RHB-107 and opaganib, to patients across the world."

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 simple once-daily oral treatment that can be prescribed and used in the largest, 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 for dose selection and to evaluate time to sustained recovery from illness as the primary endpoint. Patients are also tested for specific viral strain.

In parallel, top-line results are upcoming from the opaganib[2] global 475-patient Phase 2/3 study in patients hospitalized with severe COVID-19 - RedHill's other advanced COVID-19 oral drug candidate.