RedHill Biopharma Ltd. (NASDAQ:RDHL) has filed an application with
the Ministry of Health in Russia seeking sign-off for a Phase 2/3
clinical trial evaluating Yeliva (opaganib) in severely ill hospitalized
COVID-19 patients.
The randomized, double-blind, parallel-arm,
placebo-controlled study will enroll 270 subjects with severe COVID-19
pneumonia who are receiving supplemental oxygen. They will be randomized
1:1 to receive either opaganib or placebo on top of standard-of-care
treatment.
The primary endpoint will be the proportion of
patients requiring mechanical ventilation by day 14. Preliminary data
should be available when ~100 participants have been evaluated for the
primary objective.
The trial will include sites across Europe in addition to Russia and other countries.
Opaganib inhibits an enzyme called sphingosine
kinase-2 (SK2) which blocks the synthesis of a lipid-signaling molecule
called sphingosine 1-phosphate (S1P) that promotes cancer cell growth
and pathological inflammation.
https://seekingalpha.com/news/3581843-redhill-files-for-study-of-opaganib-in-covidminus-19
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