Members of the COVID R&D Alliance AbbVie, Inc., Amgen Inc., and Takeda Pharmaceutical Co. Ltd. announced the first patients enrolled in the I-SPY COVID Trial (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, hospitalized COVID-19 patients who require high-flow oxygen.
The I-SPY COVID Trial utilizes Quantum Leap Healthcare Collaborative’s adaptive platform trial design, which is intended to increase trial efficiency by minimizing the number of participants and time required to evaluate potential treatments.
“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 Robert J. Margolis, Center for Health Policy at Duke University and former commissioner of the U.S. FDA and administrator of the Centers for Medicare and Medicaid Services. “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 rigor necessary for regulatory evaluation.”
The study is a collaboration between members of the COVID R&D Alliance, Quantum Leap, and the U.S. 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 world’s leading biopharmaceutical 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.
“Sick patients in hospitals cannot wait; options are urgently needed. I’m proud to partner with AbbVie and Amgen and the dozens of other companies who have joined the COVID R&D Alliance, to initiate critical platform trials like I-SPY COVID,” remarked Andy Plump, President of R&D at Takeda Pharmaceuticals and co-founder of the COVID R&D Alliance. “The world learned of COVID-19 only six months ago, and the speed at which the scientific community has joined forces to address the critically high unmet need is inspiring. Together, experts across our companies and industry can accelerate trials with promising, well-understood therapies that upon investigation, may show efficacy in this devastating disease.”
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 percent of patients afflicted by COVID-19 develop acute respiratory distress syndrome (ARDS), and up to 60 percent 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 edema, 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.
Dr. Laura Esserman, co-founder of Quantum Leap Healthcare Collaborative and lead investigator of the I-SPY Trials stated, “The level of cooperation among pharma companies in response to the pandemic is unprecedented. The COVID R&D Alliance stepped forward to streamline the process of identifying safe, scalable and potentially effective agents and joined with the I-SPY consortium to propel our efforts forward at record speed. We are excited to open the trial and work to reduce the devastating effects of the virus in severely ill COVID patients, and to do it now, when we need it most.”
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. The group is employing adaptive platform trial methodologies that enable the ability to test multiple therapies simultaneously and modify protocols in real-time based on outcomes observed.
In addition to designing and sponsoring several platform trials, the COVID R&D Alliance is:
Evaluating more than 1,900 preclinical candidates against active controls to uncover which hold the greatest promise for COVID-19.
Reviewing promising early-stage candidates that may show potential efficacy against COVID-19, and connecting them with potential funders from venture capital or pharmaceutical developers to enable rapid advancement.
Working with TransCelerate’s DataCelerate® platform to enable real-time data sharing and real-world evidence to inform ongoing and future studies in COVID-19, so research communities benefit from learnings and avoid duplication.
Operating as an interlocutor with governments, regulators, and non-governmental organizations to share insights and engage in other platform trials.