RedHill Biopharma is set to start the Phase II/III study evaluating orally administered RHB-107 (upamostat) in patients with symptomatic Covid-19 who do not require hospitalisation.
The move comes after the US Food and Drug Administration (FDA) cleared the company’s Investigational New Drug (IND) application for the study.
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RedHill’s second novel Covid-19 candidate, RHB-107, can potentially inhibit several serine proteases, with demonstrated antiviral and potential tissue-protective effects.
The enrolment of participants for the study is expected to begin next year.
The randomised, parallel-group, double-blind study will analyse patients with symptomatic diagnostically confirmed Covid-19 who do not require inpatient care.
A single dose of RHB-107 will be given daily for 14 days and followed up for eight weeks after the first dosing.
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By GlobalDataTime to recovery from symptomatic illness compared to placebo, safety and tolerability of RHB-107 will be the study’s primary endpoints.
Parallelly, RedHill’s development programme with another Covid-19 candidate, opaganib, is progressing in patients with severe Covid-19 pneumonia requiring hospitalisation and treatment with supplemental oxygen.
Enrolment has been completed in a Phase II study of the candidate in the US, with topline data expected soon.
RedHill medical director Terry Plasse said: “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.”
Another global Phase II/III study of opaganib has completed 50% enrolment, with topline data expected in the first quarter of next year.
