RESEARCH TRIANGLE PARK — Grifols, a global biotherapeutics company, has begun Phase 3 clinical trials in patients with COVID-19 with its therapeutic manufactured in Clayton.
The Spanish company is testing its hyperimmune globulin for its safety, effectiveness and tolerability as a weapon to combat SARS-CoV-2, the virus that causes COVID-19.
Since April, Grifols has been collecting blood plasma donated by healthy people who have recovered from COVID-19. The company processes plasma, collected at its 300-plus donation centers, to yield hyperimmune globulin, a solution containing protective antibodies against the novel coronavirus.
The therapy contains a high and consistent concentration of purified neutralizing antibodies. The Phase 3 testing will involve 500 hospitalized adults with COVID-19, spanning up to 58 hospitals in 18 countries.
Grifols is manufacturing the experimental therapy from the plasma of healthy, recovered COVID-19 patients. Grifols was the first to deploy a large-scale collection of this plasma, as well as the first to manufacture and deliver the clinical anti-SARS-CoV-2 hyperimmune globulin.
The company’s hyperimmune globulin targets people who are hospitalized with COVID-19 but not in intensive care. It will be administered when symptoms first appear, before the immune system enables a response of its own. The goal of the therapy is to increase the body’s natural antibody response to SARS-CoV-2, which would reduce the risk of fatal progression.
Patients will either receive the hyperimmune globulin along with remdesivir, an antiviral medication invented at the University of North Carolina at Chapel Hill, or remdesivir and a placebo.
Grifols has a role in more than 25 initiatives to fight COVID-19 for patients with mild responses to life-threatening symptoms. These come from existing plasma-derived therapies, including alpha-1 antitrypsin, immunoglobulins and convalescent plasma.
“Grifols is very hopeful that all the clinical trials it is leading or participating in across different COVID-19 disease stages will advance as quickly as possible and prove to be successful,” said Víctor Grífols Deu, the company’s co-CEO.
(c) North Carolina Biotechnology Center
At Clayton plant, Grifols produces first batch of potential COVID-19 treatment