- A consortium of drug companies called the COVID R&D Alliance said Monday they have enrolled the first patients in an unusual "platform trial" that will test three different drugs in patients hospitalized with coronavirus disease.
- The study, known as the I-SPY COVID Trial, is evaluating whether Amgen's Otezla, Takeda's Firazyr and AbbVie's experimental drug cenicriviroc can combat the life-threatening immune overreactions some COVID-19 patients experience. The trial is enrolling severely ill patients who require high-flow oxygen, a group in which the death rate from COVID-19 can be as high as 50%, according to the consortium.
- The alliance, which includes Amgen, Takeda, AbbVie and 18 other drugmakers, said the I-SPY drugs were selected based on how they affect the immune system. Otezla, a psoriasis and arthritis treatment, suppresses inflammation. So does Firazyr, which treats a rare swelling disorder. Cenicriviroc, meanwhile, has been shown to block the movement of certain white blood cells, potentially altering immune responses.
The world's most powerful drug companies haven't had much luck identifying existing medicines that might help treat COVID-19, with Gilead's antiviral remdesivir and the generic steroid dexamethasone the only notable exceptions.
Yet, with the number of infections and deaths continuing to climb, their search continues — in some cases, in the form of unusual alliances and clinical trials.
Some companies, for example, are experimenting with platform trials, which gather data on multiple drugs at the same time. These trials can be flexible too, allowing researchers to drop drugs that don't appear to be working, or add in new ones based on certain criteria.
While platform trials and other kinds of adaptive studies were gaining traction before the pandemic, they've been propelled forward by the urgent need for COVID-19 treatments. The National Institutes of Health, for instance, has designed four master protocols for its Accelerating COVID-19 Therapeutic Interventions and Vaccines, or ACTIV, public-private partnership. The protocols are being used to test immune modulators, blood thinners and various types of monoclonal antibodies.
"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," Mark McClellan, director of the Robert J. Margolis Center for Health Policy at Duke University and former Food and Drug Administration commissioner, said in an Aug. 3 statement announcing the first patients enrolled in the I-SPY COVID study.
The study is one of several platform trials backed by the COVID R&D Alliance. It uses an adaptive design from Quantum Leap Healthcare Collaborative, a tax-exempt charitable organization that, alongside the FDA, is serving as a collaborator. Quantum Leap is also behind the closely watched I-SPY 2 study of breast cancer drugs. In April, Quantum Leap said the goal of I-SPY COVID would be to evaluate 10 to 20 agents in a year.
Collaborations between drugmakers, academic institutions, government entities and more — among them the COVID R&D Alliance — have been critical in helping drugmakers develop treatments for the new coronavirus as quickly as possible.
The pairings of AstraZeneca and Oxford University, Pfizer and Germany's BioNTech, and pharma giants Sanofi and GlaxoSmithKline have resulted in some of the most advanced and promising vaccine candidates. The NIH-backed COVID-19 Prevention Trials Network is working with various drugmakers to help coordinate a number of large studies testing vaccines and antibody drugs.
Takeda and CSL Behring also recently forged an alliance focused on blood plasma-derived therapies for COVID-19.