RedHill completes enrollment in the global Phase 2/3 severe COVID-19 study with oral opaganib

RedHill Biopharma Ltd. (NASDAQ:RDHL) said it has completed enrollment and randomized the last patient in the global Phase 2/3 study with oral opaganib in patients hospitalized with severe coronavirus (COVID-19) pneumonia – positioning it as a frontrunner in the hunt for an oral pill to treat COVID-19.

A total of 475 patients were randomized, more than the planned 464, with the primary endpoint of the study being the proportion of patients breathing room air without oxygen support by Day 14. Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with dual anti-inflammatory and antiviral activity, that is host-targeted and is therefore expected to be effective against emerging viral variants.

The company noted that the study also captures additional important outcome measures in the follow-up period of up to 6 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.

READ: RedHill Biopharma highlights strong end to first-quarter and almost 100% enrollment in opaganib’s Phase 2/3 study for COVID-19

An evaluation of the blinded blended intubation and mortality rates to date is encouraging, RedHill said, as compared to reported rates of mortality from large platform studies such as RECOVERY, and other studies in similar patient populations. Furthermore, four independent DSMB recommendations to continue the study were already provided following unblinded safety and futility reviews, the company added.

“Enrollment 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,” commented Mark L. Levitt, medical director at RedHill.

“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 specter of new variants, it is more critical than ever that the world has access to an oral pill to treat COVID-19″, continued Dr Levitt.

In addition to ongoing discussions with the US Food & Drug Administration (FDA) and other regulators, RedHill said it has also met with the European Medicines Agency (EMA) to talk about a European pathway. As with all discussions with regulatory bodies, next steps will be guided by study results. Discussions are also ongoing with potential partners who are interested in the rights to opaganib in various countries, it added.

Opaganib has previously delivered positive safety and efficacy signals in top-line data from a 40-patient US Phase 2 study. It has also demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib’s potential to ameliorate inflammatory lung disorders, such as pneumonia, and has shown decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids.

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