AbbVie, Amgen and Takeda Pharmaceutical, members of the COVID R&D Alliance, have enrolled the first patients in the I-SPY COVID (Investigation of Serial Studies to Predict Your COVID Therapeutic Response with Biomarker Integration and Adaptive Learning) clinical trial. The I-SPY COVID Trial will evaluate the efficacy of cenicriviroc, a chemokine (CCR2 and CCR5) dual-receptor antagonist, Otezla (apremilast), a PDE4 inhibitor, and Firazyr (icatibant injection), a bradykinin B2 receptor antagonist in severely ill, hospitalised COVID-19 patients who require high-flow oxygen.

The study is a collaboration between members of the COVID R&D Alliance, Quantum Leap, and the US Food and Drug Administration (FDA). AbbVie, Amgen, and Takeda are members of the COVID R&D Alliance (COVID R&D), a group of more than 20 of the biopharma and life science companies working to speed the development of potential therapies, novel antibodies, and anti-viral therapies for COVID-19 and its related symptoms.

“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. 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 trial strategy to evaluate promising treatments while maintaining an appropriate level of safety and statistical rigour necessary for regulatory evaluation,” said Dr Mark McClellan, Director of the Robert J. Margolis, Center for Health Policy at Duke University and former commissioner of the US FDA and administrator of the Centers for Medicare and Medicaid Services.

The therapies under investigation were selected based on their potential to impact the immune system response of COVID-19 patients who need respiratory support. Approximately 10-15 per cent of patients afflicted by COVID-19 develop acute respiratory distress syndrome (ARDS), and up to 60 per cent of those patients admitted to an ICU require ventilation for an average of two weeks. It is estimated that half of those patients will not survive. Based on the respective mechanisms of action, Otezla may suppress inflammation resulting from an immune response, Firazyr may ameliorate bradykinin-driven pulmonary oedema, and cenicriviroc acts by blocking monocytes trafficking to tissues, features that may help to reduce or mitigate the severity of ARDS response in severely ill COVID-19 patients.

I-SPY COVID is one of several platform studies being pursued by members of COVID R&D to test promising therapeutic candidates faster than any single company could do operating alone. Members are investigating marketed and late-stage therapies indicated for other disease states, which, based on their mechanisms of action may have a potential treatment effect in COVID-19 patients.