Argentina this week started clinical tests on patients using a hyperimmune solution based on equine serum, a potential medicament for treating people with Covid-19.
The previous week Argentina’s equivalent of the United States' Food & Drug Administration, the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica or ANMAT, had approved the research protocol for clinical studies of anti-Covid-19 hyperimmune serum, the biotech company Inmunova, developing the serum in co-operation with San Martín University, announced in a communiqué.
These tests will permit "the evaluation of the safety and efficiency of what could be the first Argentine medicament for treating SARS-CoV-2 infection," according to Inmunova.
The clinical studies will proceed in four hospitals, the Güemes (private) and the Pirovano (public) in the Federal Capital and two others in Buenos Aires Province, followed by 10 other health centres in the Buenos Aires metropolitan area (AMBA) concentrating 90 percent of the country’s coronavirus cases.
The treatment consists of "introducing antibodies into persons testing positive for Covid-19 with the capacity to halt and neutralise the virus, preventing the disease from developing, Fernando Goldbaum, Inmunova’s scientific director and a researcher at Conicet national scientific and technological research council, explained to AFP in mid-June when the new treatment was first announced.
In vitro testing of the serum demonstrated its capacity to neutralise the virus with around 50 times more power than the plasma of convalescent patients on average, according to the communiqué. These results were published in the Argentine journal Medicina.
The serum is an immunotherapy based on equine polyclonal antibodies, obtained via the injection of a recombinant protein of SARS-CoV-2 in horses, innocuous for them, which stimulates the generation of a great quantity of neutralising antibodies, the communiqué explains.
"You might call the horse a bio-factory since you can obtain a lot of serum from very few animals," highlighted Goldbaum, who also directs San Martín University’s Centre for Protein Redesign and Engineering as well as the immunology and molecular microbiology lab of the Fundación Instituto Leloir (FIL).
After extracting the plasma, these antibodies are purified and processed via a biotech process to obtain fragments of antibodies with high purity and a good safety profile. The serum thus produced contains a great quantity of these antibodies with a neutralising capacity, i.e. they could prevent the virus from entering cells where they multiply, the communiqué details.
Apart from Inmunova and San Martín University, the Instituto Biológico Argentino (BIOL), the Administración Nacional de Laboratorios e Institutos de Salud Dr. Malbrán, FIL, Mabxience, Conicet and the National Agency for Research Promotion have all co-operated in this project.