Page 4 - Markl Levitt News Today : Breaking News, Live Updates & Top Stories | Vimarsana

Credit: RedHill Biopharma Preliminary data from the non-powered U.S. Phase 2 study of 40 hospitalized patients shows that orally-administered opaganib was safe, with no material safety differences between opaganib and control arms Consistent trends demonstrate greater improvement in reducing oxygen requirement by end of treatment at Day 14 in the opaganib-treated arm across key primary and secondary efficacy outcomes, correlating with clinical improvement as defined by the World Health Organization (WHO) ordinal scale The opaganib-treated arm demonstrated a greater improvement in reaching ...

(2) Preliminary data from the non-powered U.S. Phase 2 study of 40 hospitalized patients shows that orally-administered opaganib was safe, with no material safety differences between opaganib and control arms Consistent trends demonstrate greater improvement in reducing oxygen requirement by end of treatment at Day 14 in the opaganib-treated arm across key primary and secondary efficacy outcomes, correlating with clinical improvement as defined by the World Health Organization (WHO) ordinal scale The opaganib-treated arm demonstrated a greater improvement in reaching room air within 14 days (...

Phase 2/3 COVID-19 study evaluates safety, potential identification of preliminary efficacy signals 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 the safety and potential identification of preliminary efficacy signals in support of the global Phase 2/3 study of opaganib. Opaganib potentially minimizes the likelihood of resistance due to viral mutations by targeting a human cell component involved...

22 dicembre 2020 Independent DSMB unanimously recommends continuation of the global Phase 2/3 study of orally-administered opaganib in severe COVID-19 based on review of unblinded safety data from 155 treated patients 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 poten...

RedHill's Phase 2/3 COVID-19 Study of Opaganib Passes Second DSMB with Unanimous Recommendation to Continue Top-line data from the 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 rep...