RedHill Biopharma Ltd (Nasdaq: RDHL), a specialty biopharmaceutical company, announced on Monday that it has completed enrolment and randomised the last patient in the global Phase two/three study with opaganib (Yeliva, ABC294640)[1] in patients hospitalised with severe COVID-19 pneumonia (NCT04467840).

The study randomised a total of 475 patients, which is more than the planned 464. The primary endpoint of the study is to find the number of patients breathing room air without oxygen support by Day 14. It includes additional important result measures in the follow up period of up to six weeks, such as the time to hospital discharge, improvement according to the World Health Organization Ordinal Scale for Clinical Improvement and incidence of intubation and mortality.

Mark L Levitt, MD, PhD, medical director at RedHill, said, 'Enrolment completion of this 475-patient global study of oral opaganib for COVID-19 is a truly exciting milestone in the urgent search for an effective pill to treat COVID-19, positioning opaganib as a leading novel, dual-action, investigational COVID-19 oral treatment. Acting on the cause and effect of COVID-19 through a dual antiviral and anti-inflammatory effect, opaganib is host-targeted and is therefore expected to be effective against emerging viral variants. With waves of COVID-19 continuing to wash over many countries, coupled with the spectre of new variants, it is more critical than ever that the world has access to an oral pill to treat COVID-19.'