RedHill Biopharma has published positive results from a Phase II clinical trial which evaluated its antiviral RHB-107 (upamostat) in non-hospitalised symptomatic patients with Covid-19.
In the randomised, multi-centre, double-blind, placebo-controlled, parallel-group trial published in the International Journal of Infectious Diseases, it was found that the once-daily orally administered investigational antiviral met the primary endpoint of tolerability and safety.
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Despite the small number of subjects in each group where they received the treatment, the antiviral delivered promising results.
In addition, the patients quickly recovered from severe Covid-19 symptoms and a 100% reduction in hospitalisation was observed in the trial.
RedHill Biopharma medical director Terry Plasse said: “Showing both safety and efficacy signals in a highly convenient once-daily oral therapy positively positions investigational RHB-107 as a potentially very useful treatment for Covid-19 outpatients to reduce symptom severity, and prevent disease progression and hospitalisation.
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“Given the growing awareness of the limitations of existing options for early treatment of Covid-19, it is vital that we do not stop our efforts to bring new options forward, especially those in which we have already observed broad-acting, host-directed, variant-agnostic abilities.”
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By GlobalDataIn the Phase II trial, non-hospitalised symptomatic Covid-19 patients received RHB-107 and were assessed for safety and tolerability.
The trial provided evidence for dose selection and preliminary assessments of parameters to be used for evaluating efficacy in a Phase III study.
For the study, the company enrolled a total of 61 subjects who were randomised on a 1:1:1 basis to receive one of two RHB-107 dose levels or a placebo control.
The trial results demonstrated a 100% reduction in hospitalisation, with zero patients in the RHB-107 arms versus 15% hospitalised in the placebo-controlled arm.
An 88% reduction was also observed in reported new severe symptoms of Covid-19 after initiating the treatment.
Only 2.4% of the RHB-107 treated group, against 20% of subjects in the placebo-controlled arm, reported new severe symptoms.
In March last year, Redhill Biopharma reported positive results from the Phase II part of the Phase II/III trial of RHB-107 in non-hospitalised symptomatic Covid-19 patients.
