Biopharmaceutical firm Grifols, which specializes in development of therapies harnessing plasma-derived proteins, has announced it is kicking off a clinical trial in Spain to test the viability of a potential COVID-19 treatment. Based on the company’s immunoglobulin Gamunex-C and containing polyclonal antibodies, the drug at the center of the study reportedly has the potential to deliver immunity against the virus.
According to researchers, the novel drug could provide immediate post-exposure protection against the COVID-19 virus, with the potential to complement vaccines in the early post-vaccination phase. The company predicts it could be useful in safeguarding the elderly, healthcare workers, immunocompromised patients and other vulnerable populations, especially in the face of outbreaks where vaccination has yet to begin.
Oriol Mitjà, a lead researcher with Germans Trias I Pujol Hospital in Barcelona, said, "This treatment based on immunoglobulins would provide a combination of polyclonal antibodies that, compared with monoclonal antibodies, offers a greater diversity that could improve the degree of protection against the virus."
Grifols expects the trial, led by Mitjà and colleague Bonaventura Clotet, to begin in February 2021, with early results possibly coming through in spring. The company anticipates to enroll approximately 800 patients (tested positive but asymptomatic), each receiving subcutaneously delivered Grifols' immunoglobulin with anti-SARS-CoV-2 antibodies.
Grifols reports that immunoglobulin Gamunex-C (which can be administered intravenously, intramuscularly or subcutaneously) has proven to be safe and efficacious in the prevention of diverse infectious diseases in immunocompromised patients. The company reports it has been using the treatment in such indications for more than 15 years.
Grifols medical director Antonio Páez reports that the potential treatment "is easy to refrigerate while its subcutaneous administration facilitates its distribution and use in any doctor's office, avoiding hospitalization. If the new therapy's efficacy is confirmed, it could be administered to people who test positive for the virus through PCR and antigen tests in hospitals and primary care offices."
Grifols currently is exploring a wide array of potential COVID-19 treatments. To date, it has launched more than 25 research initiatives to treat different stages of COVID-19, ranging from early exposure to severe cases requiring hospitalization and intensive care.
In October, Grifols partnered with other firms and a variety of US health agencies to launch the Inpatient Treatment with Anti-coronavirus Immunoglobulin (ITAC) clinical trial. Results of the study, designed to evaluate the efficacy and safety of the anti-SARS-CoV-2 hyperimmune globulin in hospitalized and serious cases, are expected in the first half of this year.