Grifols to Begin Clinical Trial of New COVID-19 Drug

Global biotherapeutics giant Grifols will soon start a clinical trial for what could become the next approved treatment for COVID-19.

The trial will begin in February in Spain, where Grifols is headquartered.

Grifols logoThe company, which has a major manufacturing presence in Clayton, said the new therapy is based on its immunoglobulin Gamunex-C. It contains COVID-19 polyclonal antibodies derived from the blood plasma of donors who have recovered from the coronavirus infection.

If successful, the drug – which will be administered subcutaneously (under the skin) during the trial – should provide immediate post-exposure protection against the virus, according to Grifols. It could help safeguard the elderly and healthcare workers in the days right after they receive a COVID-19 vaccine, as well as immunocompromised patients for whom a vaccine isn’t recommended. And it could be used to contain coronavirus outbreaks in areas where a vaccination program hasn’t yet begun, or is still underway.

Two researchers from Germans Trias I Pujol Hospital in Barcelona will lead the trial. Grifols said it could have results as early as this spring.

About 800 patients who have tested positive for COVID-19 but are asymptomatic will be enrolled. They will receive Grifols’ immunoglobulin rich with anti-SARS-CoV-2 antibodies. SARS-CoV-2 is the scientific name for COVID-19. The hope is that these antibodies can safely stimulate patients’ immune systems to respond to the infection.

Grifols said Gamunex-C has been used for more than 15 years to protect against infectious diseases in immunocompromised patients and has proven safe and effective.

More than two dozen COVID-19 initiatives underway

The company said it currently has more that 25 research initiatives underway to treat different stages of COVID-19, from early exposure to severe cases that require hospitalization and intensive care.

In October 2020, Grifols joined other companies and several U.S. health agencies to began the ITAC (Inpatient Treatment with Anti-Coronavirus Immunoglobulin) clinical trial. It is designed to gauge the safety and effectiveness of the anti-SARS-CoV-2 immunoglobulin in more serious cases of COVID-19. Results are expected during the first half of this year.

The company – founded in Barcelona in 1909 – is a global leader in the production and distribution of immunoglobulins and hyperimmune immunoglobulins. It has more than 24,000 employees and sells its products in over 100 countries.

Grifols is known for its work in plasma-derived and transfusion medicines. The company also operates a network of donation centers worldwide and transforms collected plasma into medicines to treat rare, chronic and, at times, life-threatening conditions.

A major presence in North Carolina

Grifols opened a $400 million plasma-fractionation plant in Clayton in 2014 and is currently building a new $90 million fractionation facility that should begin operations in 2021.

Grifols site in Clayton North Carolina
Grifols site in Clayton, North Carolina

The company also is constructing a $120 million purification and filling plant in Clayton that will primarily produce immunoglobulin and factor VIII protein therapies. It is scheduled to open in 2022. Factor VIII – a blood protein involved in clotting – treats the bleeding disorder hemophilia A.

With the expansions, the Clayton site is becoming one of the world’s largest manufacturing locations for plasma-derived medicines. Its workforce of more than 1,600 makes it the biggest employer in Johnston County.

Grifols also has a bioscience division headquarters in Research Triangle Park that employs more than 400 people.

Bryant Haskins, NCBiotech Writer
Tue, 01/19/2021 - 11:39