- RedHill Biopharma Ltd RDHL has reported new data from the opaganib global Phase 2/3 study in hospitalized COVID-19 patients with severe pneumonia.
- Related: What's Happening With RedHill Biopharma's Stock On Tuesday?
- The data comes from a post-hoc analysis of data from the 251 study participants requiring a Fraction of inspired Oxygen (FiO2) up to 60% at baseline.
- The data showed that treatment with oral opaganib vs. the placebo-controlled arm resulted in a 62% statistically significant reduction in mortality.
- 77% of opaganib-treated patients reached room air by Day 14 vs. 63.5% for placebo - an efficacy benefit of 21% with opaganib.
- Patients treated with opaganib showed a median time of 10 days to discharge vs. 14 days for the placebo arm.
- Overall adverse events were balanced between the opaganib and placebo groups, suggesting good safety, with no new safety signals.
- The new data of the sub-group analysis follows the Company's previously announced top-line results of the Phase 2/3 study.
- Related: Merck COVID-19 Oral Antiviral Cuts Risk of Hospitalization, Death By 50%.
- Analysis of the top-line data is still ongoing, including further analysis of the potential for the increased benefit of treatment with opaganib in patients at earlier stages of the disease.
- RedHill intends to discuss the study outcomes with regulators to help determine the next steps.
- Price Action: RDHL shares closed 11.67% higher at $4.88 on Monday.
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