RedHill Biopharma Ltd (NASDAQ:RDHL) has 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) for non-hospitalized patients with symptomatic coronavirus (COVID-19), currently being conducted in the US 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 two-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
READ: RedHill Biopharma accelerates US Phase 2/3 COVID-19 study of once-daily oral RHB-107 in non-hospitalized patients with South African approval
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.
Dr. Terry F. Plasse, medical director at RedHill commented: "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."
"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," he added.
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.
In parallel, data packages for opaganib, RedHill's other advanced novel oral COVID-19 drug candidate, have been submitted to regulators in various territories including the US, 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.
RedHill Biopharma is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases.
Contact the author at jon.hopkins@proactiveinvestors.com
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