The US FDA has cleared RedHill Biopharma’s Investigational New Drug (IND) application for a Phase 2/3 study evaluating orally administered RHB-107 (upamostat) in patients with symptomatic COVID-19 who do not require hospitalisation.
RHB-107 is a proprietary, first-in-class, orally administered potent inhibitor of several serine proteases, with demonstrated antiviral and potential tissue-protective effects.
This combined antiviral and potential tissue-protective action make it a promising candidate for evaluation as a treatment for COVID-19 disease.
RHB-107 has demonstrated strong inhibition of SARS-CoV-2 viral replication in an in vitro human bronchial cell model and its safety profile has been demonstrated in approximately 200 people, including in Phase 2 studies in oncology indications. RedHill licensed RHB-107 (formerly Mesupron) from Heidelberg Pharma AG (FWB: HPHA, formerly Wilex AG).
The randomized, parallel-group double-blind Phase 2/3 study is expected to start enrolling patients early next year.
The study will enroll patients with symptomatic diagnostically confirmed COVID-19 who do not require inpatient care. RHB-107 will be administered once daily for 14 days, with patients receiving follow-up for eight weeks from first dosing.
The primary endpoints will be time to recovery from symptomatic illness compared to placebo, as well as safety and tolerability of RHB-107. Several secondary and exploratory endpoints will also be assessed.
“This is a significant milestone in our efforts to combat the effects of the COVID-19 pandemic,” said Terry F. Plasse Medical Director at RedHill.
“The ability to treat patients earlier in the course of COVID-19 disease, using an oral therapy that enables treatment outside of a hospital setting, is of critical importance given the large proportion of patients that are not hospitalised but are still very much at risk of disease progression.
“With RHB-107 and opaganib, RedHill has two novel, late-stage, oral therapeutic candidates with potential to reduce the impact of COVID-19 disease, both of which target host cell components, potentially minimising the likelihood of resistance due to emergence of viral mutations.”