62% statistically significant reduction in mortality shown for moderately severe COVID-19 patients group treated with opaganib vs. the placebo-controlled arm (7 deaths in the 117-patient opaganib arm vs. 21 deaths in the 134-patient placebo arm; nominal p-value=0.019)
21% statistically significant efficacy benefit with opaganib in reaching room air by Day 14, the study primary endpoint (77% of opaganib patients vs 63.5% on placebo; nominal p-value=0.033)
A median four days earlier hospital discharge for opaganib-treated patients vs. placebo (10 days for opaganib arm vs. 14 days for placebo) a cumulative saving of 524 days of hospitalization across the group by Day 42 (nominal p-value=0.0195)
The moderately severe group comprised 53% of study participants requiring a Fraction of inspired Oxygen (FiO2) up to 60% at baseline (inhaled supplemental oxygen via nasal cannula or face mask)
Data indicates a potential meaningful benefit with opaganib for these hospitalized, moderately severe COVID-19 patients - a group at high risk of disease progression, morbidity and mortality; the data also supports opaganib's potential use in earlier stages of COVID-19 disease, consistent with opaganib's U.S Phase 2 study results and the demonstrated potent antiviral inhibition of SARS-CoV-2 variants
RedHill will hold a webcast on Thursday, October 7, 2021, at 08:30 am EDT to further discuss these additional analyses
Webcast and Conference Call Information:
The Company will host a webcast on Thursday, October 7, 2021, at 8:30 a.m. EDT, during which it will present the additional analysis of the Phase 2/3 study results and answer questions.
The webcast including slides will be broadcast live on the Company's website, https://www.redhillbio.com/investors/events-and-presentations/default.aspx, and will be available for replay for 30 days.
To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-877-870-9135; International: +1 646-741-3167 and Israel: +972-3-530-8845; the access code for the call is: 4785122.
https://finance.yahoo.com/news/redhill-biopharma-reports-further-analysis-120000369.html
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