- In the final analysis of the Phase 3 cinical study conducted by Veru Inc., sabizabulin showed a 51.6% reduction in deaths compared to placebo in hospitalized adult patients with moderate to severe COVID-19 who are at high risk for ARDS
- Sabizabulin also showed a significant reduction of days in ICU, days on mechanical ventilation and days in the hospital
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The Phase 3 COVID-19 clinical trial of sabizabulin was a double-blind, randomized, placebo controlled trial conducted in 204 hospitalized COVID-19 patients with moderate to severe COVID-19 (≥ WHO 4-supplemental oxygen) at high risk for ARDS and death. The primary endpoint was the proportion of deaths by Day 60. Patients in both treatment groups were allowed to receive standard of care treatment, including remdesivir, dexamethasone, anti-IL6 receptor antibodies and JAK inhibitors. Based on a planned interim analysis of the first 150 patients randomized, the Independent Data Monitoring Committee unanimously recommended to halt the study early for clear clinical efficacy and no safety concerns were identified. Treatment with sabizabulin 9 mg once daily, an oral, first-in-class, new chemical entity, microtubule disruptor that has dual anti-inflammatory and antiviral properties, resulted in a clinically meaningful and statistically significant 55.2% relative reduction in deaths compared to placebo. The results of the interim analysis were published in
Valeo previously announced in
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