RedHill Biopharma, a specialty biopharmaceutical company, has announced that the first patient was dosed in its US Phase II/III study of orally-administered RHB-107 (upamostat)[i], an investigational new drug for patients with symptomatic COVID-19 who do not require hospital care.
Dror Ben-Asher, RedHill’s CEO said: “RedHill is rapidly advancing two Phase III-stage, orally-administered, novel molecules for the treatment of COVID-19: RHB-107 for outpatient use and opaganib for hospitalised patients. With these two promising and complementary shots on goal across the disease severity spectrum, RedHill is positioned at the very forefront of COVID-19 therapeutic research, aiming to address both existing and emerging mutations.”
The US Phase II/III study (NCT04723527) is aimed at evaluating treatment with RHB-107 in patients with symptomatic COVID-19 early in the course of the disease, with a simple once-daily oral treatment in an outpatient setting.
RHB-107 is a novel, potent inhibitor of serine proteases, that targets human cell factors involved in preparing the spike protein for viral entry into target cells and is therefore expected to be effective against emerging viral variants with mutations in the spike protein. RHB-107 demonstrated strong inhibition of SARS-CoV-2 viral replication in an in vitro human bronchial epithelial cell model and previous preclinical work demonstrated potential tissue-protective action. Previous clinical studies of RHB-107 included several Phase I and Phase II studies in different indications, demonstrating its clinical safety profile in approximately 200 patients.
“Dosing of the first patient in the Phase II/III study of RHB-107 in patients with symptoms but not needing hospital care, the largest COVID-19 patient group, is a key step forward in RedHill’s efforts to help combat the widespread effects of this pandemic. Together with opaganib, we now have two novel, orally-administered compounds, with unique mechanisms of action, in advanced development for treating patients at different stages of COVID-19 disease,” said Terry Plasse, Medical Director at RedHill.
“The ability to treat patients early in the course of COVID-19 disease, with an oral therapy designed to be used outside the hospital, and with a compound expected to be effective against emerging viral variants, has the potential to be a game-changer in managing this disease. The ground-breaking design of the study allows us to collect data at a level previously possible only in hospital while enabling patients to stay in the comfort of their homes and decreasing exposure risk of this highly contagious disease.”
[i] RHB-107 (upamostat) is an investigational new drug, not available for commercial distribution in the United States.