Amgen Inc, UCB SA and Takeda Pharmaceuticals Inc on Monday launched a global trial to identify whether any of three different drugs can reduce the severity of COVID-19 in hospitalized patients by moderating the immune system's response to the disease.
The drugmakers are part of the COVID Research & Development Alliance, a group of more than 20 pharmaceutical and biotechnology companies cooperating to speed development of therapies for the disease that has killed more than 1.4 million people worldwide.
The study initially will test whether Amgen’s psoriasis drug Otezla, Takeda’s experimental anti-inflammatory lanadelumab, and UCB's experimental immune system-inhibitor zilucoplan can prevent the body's own defenses from overreacting to the coronavirus, which can lead to serious, sometimes fatal, tissue and organ damage.
The three compounds "have a plausible biologic rationale in terms of effect on immune response or the hyper-immune response that some people develop," said Amgen research chief David Reese.
"We hope to find options that could potentially save lives ... before widespread availability of a vaccine,” he said.
Health experts do not expect vaccines to be available to most people until well into 2021. Meanwhile, COVID-19 hospitalizations are at record levels in the United States, threatening to overwhelm health systems.
The multiple candidates will be tested against a placebo with all trial patients also receiving standard care. Other drugs that work in a variety of ways, including antivirals, medicines that also modulate immune response and vascular agents may enter the study in coming months.
So far, only a generic class of steroids used since the 1960s to reduce inflammation in diseases such as arthritis has been shown in a controlled study to improve survival for severely ill hospitalized COVID-19 patients. Steroids are not recommended for patients with less severe illness.
The COVID R&D trial will enroll both hospitalized intensive care unit and non-ICU patients.
In anticipation of a rise and fall of COVID-19 cases in various geographic regions, the trial will include sites in the United States, Brazil, Mexico, Russia, South Africa and other countries.
“COVID is not confined to one country ... We have included a broad range of different countries," said Dhavalkumar Patel, UCB's chief scientific officer.
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