Credit: RedHill Biopharma
Top-line data from the 270-patient global Phase 2/3 COVID-19 study expected Q1/2021
Top-line data from the 40-patient U.S. Phase 2 study of opaganib in severe COVID-19 expected in the coming days; this non-powered study was designed to evaluate safety and potential identification of preliminary efficacy signals in support of the global Phase 2/3 study of opaganib
Opaganib potentially minimizes likelihood of resistance due to viral mutations by targeting a human cell component involved in viral replication
TEL AVIV, Israel and RALEIGH, NC, December 22, 2020, RedHill Biopharma Ltd. (Nasdaq: RDHL) ( RedHill or the Company ), a specialty biopharmaceutical company, today announced that the global Phase 2/3 study with orally-administered opaganib (Yeliva®, ABC294640) in patients hospitalized with severe COVID-19 pneumonia has received a second unanimous recommendation to continue, following a second independent Data Safety Monitoring Board (D
RedHill s Phase 2/3 COVID-19 Study of Opaganib Passes Second DSMB with Unanimous Recommendation to Continue | ANP Pers Support
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RedHill s Phase 2/3 COVID-19 Candidate Opaganib Reduces ARDS-Related Blood Clotting in Preclinical Model
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Credit: RedHill Biopharma
Acute respiratory distress syndrome (ARDS)-induced thrombosis (blood clotting) may occur in up to one-third of COVID-19 patients requiring ICU admission and is a contributing cause of mortality
Opaganib demonstrated reduced thrombosis in a preclinical model of ARDS
Opaganib has also been shown to inhibit SARS-CoV-2 viral replication as well as pro-inflammatory markers in relevant preclinical models
Top-line data from the U.S. Phase 2 study of orally administered opaganib in patients with severe COVID-19, evaluating safety and potential efficacy signals, is expected later this month following the last patient s last dose administered on November 26
Top-line data from a global Phase 2/3 study of opaganib in patients with severe COVID-19, currently more than 60% enrolled, is expected in Q1/2021 with potential global emergency use applications to follow