Sabizabulin 9mg for the treatment of hospitalized moderate to severe COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS)
Current Clinical Trial
Phase 3 COVID-19 registration clinical study.
We are enrolling patients into a double-blind randomized (2:1) placebo-controlled Phase 3 COVID-19 registration clinical trial evaluating daily oral doses of sabizabulin 9mg for 21 days versus placebo in moderate to severe COVID-19 hospitalized subjects who are at high risk for developing ARDS, which remains an unmet medical need. The primary efficacy endpoint will be proportion of patients alive at Day 60. Secondary endpoints will include the proportion of patients alive without respiratory failure, days in ICU, days on mechanical ventilations, days in the hospital, and viral load. The Company will enroll 300 subjects from clinical sites in the U.S., Brazil, Argentina, Colombia, Mexico, and Bulgaria. The Company anticipates completion of enrollment of the Phase 3 trial early in calendar year 2022.
Market
Approximately 20% of symptomatic cases require hospitalization with 5% ending up in the ICU. According to U.S. Centers for Disease Control and Prevention, there have been approximately 48 million confirmed COVID cases and approximately 777,000 deaths in the U.S. as of November 28, 2021. While many factors go into the market analysis such as the prevalence of vaccination as well as both the development and the severity of virus mutations, the Company believes that the market opportunity for the indication, if approved, is greater than $1 billion in the US.
https://verupharma.com/pipeline/sabizabulin-for-covid-19/
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