RedHill Biopharma (NASDAQ:RDHL) (NASDAQ:RDHL) announced that South Africa has joined the US in approving the Phase 2/3 study of its once-daily, orally administered pill RHB-107 (upamostat) for non-hospitalized patients with symptomatic coronavirus (COVID-19).
The specialty biopharmaceutical company said the study is already ongoing in the US, with expansion of study sites underway to further accelerate recruitment.
RHB-107 is an antiviral drug candidate that targets human serine proteases involved in preparing the spike protein for viral entry into target cells. Since 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, said the company.
RedHill said RHB-107 also 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 US 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," Terry F Plasse, the Medical Director at RedHill said in a statement.
"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 US, 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 two-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.
RHB-107 has potential in several indications in oncology, inflammatory and gastrointestinal disease. RHB-107 has undergone several Phase 1 studies and two Phase 2 studies, demonstrating its clinical safety profile in approximately 200 patients.
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