NIH funds study of high antibody concentrations combined with the antiviral remdesivir
The National Institute of Allergy and Infectious Diseases said a group of companies including Japanese drugmaker Takeda Pharmaceutical Co. TAK +0.11% began testing an experimental treatment for hospitalized Covid-19 patients that is derived from the convalescent plasma of people who have recovered from the new coronavirus.
The NIAID, a division of the National Institutes of Health, or NIH, is funding the study, which will enroll 500 hospitalized patients from across Africa, Asia, Europe, and North and South America, the NIAID said Thursday. The trial will compare the new drug in combination with the antiviral medication remdesivir made by Gilead Sciences Inc.,GILD +0.84% versus a treatment of remdesivir and a placebo.
The drug being tested combines anti-coronavirus antibodies derived from blood samples taken from multiple recovered patients. The aim is to make a more potent and effective form of so-called convalescent plasma therapy than is usually derived from a single patient. The new drug is called “hyperimmune intravenous immunoglobulin,” or hIVIG, and is sometimes referred to simply as “hyperimmune.”
“We take the coronavirus convalescent plasma, and we pool it so there are literally thousands of donations that go into a manufacturing pool and we pull out the antibodies, purify it, and concentrate it down into the final medicine vial,” said Julie Kim, president of Takeda’s plasma-derived therapies unit.
The hyperimmune drug is made from the liquid component of blood, or plasma, which contains antibodies. Convalescent plasma is a form of treatment in which plasma collected from recovered patients is transfused directly to Covid-19 patients. Researchers hope the antibodies developed by the recovered patients can bolster the immune systems of new patients and help defeat coronavirus infections.
Several companies are involved in collecting and providing the anticoronavirus antibodies that make up the drug being tested. Alongside Takeda, based in Tokyo, scientists fromEmergent BioSolutions Inc. of Gaithersburg, Md., CSL Behring LLC of King of Prussia, Pa., and Grifols SA of Barcelona also collected plasma donated by healthy people who have recovered from Covid-19 infections.
The NIAID study will follow patients for 28 days and could be completed by the end of this year or in early 2021, said Bill Mezzanotte, CSL Behring’s global head of R&D and chief medical officer. If the drug shows a benefit in improving patient symptoms, it can be used by multiple companies to seek approval for their hyperimmune products, he said.
The study is the latest of several efforts evaluating experimental drugs made from plasma donated by recovered patients. In July, Emergent BioSolutions announced plans to work with Mount Sinai Health System in New York City to test whether its own drug derived from the blood plasma of recovered Covid-19 patients can prevent infections in doctors, nurses and military forces. In August, U.S. regulators granted an emergency-use authorization for convalescent plasma in treating seriously ill Covid-19 patients.
The NIAID study announced Thursday differs from these efforts in that the treatment contains several times more anticoronavirus antibodies than are typically contained in convalescent plasma, the institute said. Researchers pool the various plasma donations and purify and concentrate the antibodies, creating what is known as hyperimmune globulin.
Whereas convalescent plasma must be used within 24 hours, hyperimmune globulins can be stored for as long as three years, according to Takeda. Such therapies have been shown to be effective in treating severe acute viral respiratory infections, the company said.
Takeda announced its drug-development plan in March, and a month later it formed a partnership with CSL Behring, and eventually other companies, for collaboration on research and development, manufacturing and plasma collection. One reason for the collaboration was to speed up development. Takeda said in March that, if testing is successful, the company aimed to make the therapy available by about the end of the year.