Policy & Regulation
RedHill announces viral clearance in severely ill hospitalized COVID-19 patients following oral opaganib Phase 2/3 study
14 January 2022 -

Biopharmaceutical company RedHill Biopharma Ltd (Nasdaq:RDHL) said on Thursday that the first oral novel drug candidate Opaganib improved the median time to viral RNA clearance by at least four days in a Phase 2/3 study patients with positive PCR at screening.

The company added that the treatment with opaganib resulted in viral RNA clearance in a median of ten days while the median for clearance in the placebo arm was not reached by the end of 14-days treatment for placebo.

In conjunction, Opaganib was studied in a global Phase 2/3 study in hospitalized patients with severe COVID-19 pneumonia (NCT04467840) with positive PCRs at screening obtained for 437 out of 463 patients.

Under the study, the results from a post-hoc analysis of data from 251 study participants requiring a Fraction of inspired Oxygen (FiO2) up to and including 60% at baseline demonstrated that treatment with oral opaganib resulted in a 62% reduction in mortality as well as improved outcomes in time to room air, median time to hospital discharge, revealed the company.

Opaganib is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with proposed dual anti-inflammatory and antiviral activity. Opaganib is host-targeted and is expected to be effective against emerging viral variants, having demonstrated strong inhibition against variants of concern, including Delta, concluded the company.