RedHill Biopharma Inc. (NASDAQ: RDHL) stock declined by 30.08% in the current market trading session. RedHill Biopharma is a gastrointestinal and infectious disease-focused specialized biopharmaceutical business.
RDHL stock’ Current Development
Initial top-line data from a 475-patient worldwide Phase 2/3 study with opaganib in hospitalized patients with chronic COVID-19 pneumonia were released by RedHill Biopharma Ltd. The report’s primary goal was not met, according to preliminary top-line statistics. However not reaching statistical validity, analysis of the study effectiveness endpoints revealed trends in favor of the opaganib arm vs. placebo across numerous endpoints, including the primary endpoint.
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Top-line safety statistics showed that opaganib was well tolerated, with equally distributed adverse events across the research arms. These research results, along with preliminary analysis indicating increased benefit in a subset of patients needing less oxygen, could endorse the use of opaganib in the early stages of the disease and are consistent with earlier announced outcomes from the U.S. Phase 2 study and opaganib’s antiviral activity.
The 475 individuals in the multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 research had severe COVID-19 pneumonia that necessitated hospitalization and supplementary oxygen treatment. On top of conventional treatment, subjects were randomly assigned to receive either opaganib or placebo in a 1:1 ratio. The percentage of patient’s breathing room air without oxygen aid on Day 14 is the study’s primary goal.
The early top-line findings from the Company’s Phase 2/3 research with opaganib are depending entirely on top-line information provided to the Company by an independent third-party contractor. The Company plans to dig deeper into the data from this trial, as well as all of the information obtained during it, along with all safety and secondary outcome indicators. Such study could produce results that contradict the top-line data disclosed in this publication. As a result, investors should not consider the top-line results disclosed in this release to be the study’s final definitive results.