RedHill Biopharma says first patient dosed in ground-breaking RHB-107 Phase 2/3 study of coronavirus outpatients

RedHill Biopharma Ltd (NASDAQ:RDHL) announced Wednesday that the first patient was dosed in its US Phase 2/3 study of orally-administered RHB-107 (upamostat), an investigational new drug for patients with symptomatic coronavirus (COVID-19) who do not require hospital care.

In a statement, RedHill’s CEO Dror Ben-Asher told investors that the company is “positioned at the very forefront of COVID-19 therapeutic research, aiming to address both existing and emerging mutations.”

The Tel Aviv and Raleigh, North Carolina-based firm is quickly advancing two Phase 3-stage novel, orally-administered, potential COVID-19 treatments: RHB-107, for outpatient use, and opaganib for hospitalized patients.

READ: RedHill Biopharma receives unanimous support from DSMB for global Phase 2/3 trial of opaganib

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. According to RedHill, the treatment is 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 1 and Phase 2 studies in different indications, demonstrating its clinical safety profile in approximately 200 patients.

The US Phase 2/3 study will look at evaluating patients with symptoms early on in the course of the disease using a once-daily dose of RHB-107 in an outpatient setting.

RedHill’s medical director Terry Plasse called Wednesday’s news “a key step forward” in the company’s efforts to help fight the coronavirus 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,” Plasse told shareholders in a statement.

“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.”

The study has two parts – the first part of the study is designed for dose selection and is planned to enroll 60 patients, while the second part of the study is planned to enroll 250 patients and will evaluate time to sustained recovery from illness as the primary endpoint.

Each patient will be tested for specific viral strain, RedHill added.

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