EUSA Pharma Announces FDA Approves Phase 3 Clinical Trial Of Silvoximab For COVID-19-Related Acute Respiratory Distress Syndrome Patients
EUSA Pharma, a global biopharmaceutical company focused on tumors and rare diseases, announced, The US Food and Drug Administration (FDA) has approved a randomized, double-blind, placebo-controlled phase 3 clinical trial plan to evaluate Siltuximab combined with standard treatment in COVID-19-related acute respiratory distress syndrome (ARDS) hospitalized patients Safety and effectiveness.
Siltuximab is a monoclonal antibody that directly neutralizes the inflammatory cell hormone interleukin (IL)-6. Increased IL-6 levels can be detected in various inflammatory diseases (including COVID-19). Siltuximab can specifically bind to IL-6, and then inactivate IL-6-induced signal transmission.
Lee Morley, CEO of EUSA Pharma, said : "Since the beginning of the pandemic, more and more published evidence shows that COVID-19-related ARDS may show up due to excessive cytokine production (the so-called "cytokine storm"). Characterized by excessive inflammation throughout the body, IL-6 is considered a key driver of this serious condition. Therefore, treatment methods that neutralize IL-6 may play a key role in mitigating further harmful inflammatory reactions and progressing to fatal respiratory failure. We thank FDA for recognizing the importance of this clinical trial and the rapid approval we received. We now plan to start the study as soon as possible, hoping to see improved clinical treatment results for the above-mentioned critical patients. "
To date, several independent clinical trials have begun to explore the safety and effectiveness of Siltuximab in the treatment of severe COVID-19 patients. The SISCO 1 ( S iltuximab I n S erious CO VID-19, S iltuximab treatment for severe COVID-19) study sponsored by Papa Giovanni XXIII Hospital is an observational cohort controlled study designed to study Siltuximab combined with standard treatment for patients with severe For COVID-19 patients with respiratory complications, the final result can be obtained by clicking the preprinted summary here 2 . However, this newly approved confirmatory clinical trial is crucial because the above results need to be verified by well-controlled randomized studies, and the published data on the safety and efficacy of Siltuximab in the treatment of COVID-19 is limited. The FDA has not approved Siltuximab for COVID-19 related complications.