A large Phase II clinical trial designed to rapidly screen drugs as potential treatments for critically ill Covid-19 patients has enrolled its first patients.
Three of the companies taking part in the I-SPY COVID-19 trial – Thousand Oaks, California-based Amgen, Chicago-based AbbVie and Tokyo-based Takeda Pharmaceutical – made the announcement Monday. The trial is part of a partnership between between the Covid R&D Alliance – comprising more than 20 biopharmaceutical and life science companies, including the aforementioned three – as well as the Food and Drug Administration and the QuantumLeap Healthcare Collaborative. It is designed to enroll up to 1,500 patients requiring high-flow oxygen or ventilation and currently lists 10 sites across the U.S.
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I-SPY COVID-19 is an adaptive platform trial designed to provide access to repurposed or experimental drugs – including AbbVie’s cenicriviroc, originally developed for HIV; Amgen’s autoimmune disease drug Otezla (apremilast); and Takeda’s hereditary angioedema drug Firazyr (icatibant) – along with Gilead Sciences’ antiviral for Covid-19, remdesivir, according to ClinicalTrials.gov. It is anticipated that the study will enroll 50 patients per week, enrolling up to 125 per arm without graduation and dropping agents for futility after the enrollment of 50. Up to 10 drugs could be investigated over four to six months. The primary endpoint will be the time in which patients reach a level of having hospitalized mild disease or better. The study will evaluate exploratory biomarkers over time, such as acute respiratory distress syndrome phenotypes and others.
“Collaborative research efforts leveraging adaptive platform trials enable faster and more complete learning about what works for patients, and they are especially critical for addressing urgent public health threats like Covid-19,” said Dr. Mark McClellan, director of the Center for Public Health Policy at Duke University, in a statement. “Platform trials bring down the cost and increase the ease of executing well-powered, high-quality studies, especially when multiple, potential therapies need to be evaluated quickly. The I-SPY COVID Trial is expanding a timely and effective platform strategy to evaluate promising treatments while maintaining an appropriate level of safety and statistical rigor necessary for regulatory evaluation.”
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