Nasalferon, drops of life against COVID-19

HAVANA, Cuba, Mar 14 (ACN) Developing a drug and seeing its results are, on many occasions, conflicting ideas for scientists, since obtaining a drug can take between 10 and 15 years. However, changing the timing of science has been one of the factors in favor of confronting SARS-CoV-2, the cause of the COVID-19 pandemic.

In early 2020, the Center for Genetic Engineering and Biotechnology (CIGB), with nearly 40 years of experience in the production of interferons, did not have a formulation of this molecule for the nasal route, a situation that would change four months later with the manufacture of Nasalferon.
How did it come about?

Doctor of Pharmaceutical Sciences Ana Aguilera Barreto, head of CIGB's Formulation and Packaging Department of Technological Development, told the Cuban News Agency that Nasalferon was born from the experience accumulated at the center and the importance of protecting the nasal route.

In 1981, human leukocyte alpha interferon was used in Cuba: the first one achieved in the country, during the hemorrhagic conjunctivitis epidemic. On that occasion, scientists used it in the form of eye drops, and the similarity between the formulations served as a precedent for Nasalferon, she noted.

When the coronavirus appeared and it became known that the entry door to the system was through the nasopharyngeal route, in China, recombinant human interferon alpha 2b produced in the Caribbean nation began to be administered through that route, and from Cuba, it was thought of converting it into a solution for nasal administration.

The specialist, who won the 2021 National Technological Innovation Award for the new formulation, explained that interferon is the body's first line of defense and SARS-CoV-2 reduces its presence in the blood. Therefore, the aim of Nasalferon is to increase the molecule's markers to combat the disease, thanks to the immunomodulatory and antiviral properties of interferon alpha.

First steps: clinical research

A multidisciplinary team was formed at the CIGB to develop the drug, which from the preclinical research and the subsequent clinical trial demonstrated safety and signs of efficacy; in addition to the fact that it did not cause irritation to the nasal area, nor toxic effects associated with its administration, Aguilera Barreto pointed out.

When on March 11, 2020 the World Health Organization declared COVID-19 a pandemic and the first cases of the disease were detected in Cuba, CIGB scientists were already working on the molecule that would later become Nasalferon.

By April 8 of that year, the first batch was produced, which meant a production record. At the same time, pharmacology and toxicology studies had been carried out, first in cells and then in laboratory animals, formulation and stability tests of the product and the clinical trial, with the purpose of obtaining answers on stability, irritability and advantages of the formulation.

Likewise, she emphasized, the quality controls were adjusted since it is a new product and, as it complied with all the requirements, the Cuban regulatory authority, the Center for State Control of Medicines, Equipment and Medical Devices, granted the authorization for emergency use in January 2021.

Nasalferon: advantages beyond COVID-19

Nasalferon was initially conceived to prevent the contagion of health personnel, but as cases of COVID-19 increased in the country, its use was extended therapeutically, so that patients would not suffer from severe forms of the disease and would eliminate the virus in a shorter period of time.
The Head of the Formulation and Packaging Department of CIGB's Technological Development commented that it began to be administered immediately in the health system, and after the approval of the Cuban regulatory authority, its indication was extended.

To date, more than one million bottles have been manufactured jointly by the CIGB and AICA Laboratories and more than 700,000 have been distributed for preventive and therapeutic treatment in nursing homes, Henry Reeve Contingent brigades, international travelers, home admissions and, in general, in COVID-19 positive patients, the expert explained.

Although the incidence of SARS-CoV-2 has decreased in the country, the production of the drug remains constant. Its application in acute respiratory infections is also being studied, so that once the sanitary registration is obtained, it will be included in the CIGB portfolio with a more extended use and not only in COVID-19, the specialist continued.

For Aguilera Barreto, as for the team that accompanies her, obtaining Nasalferon has been one of the greatest challenges assumed in the institution, because "it was necessary to give a rapid response to an atypical situation, it was necessary to acquire knowledge and seek information".
"Having the responsibility of researching a product that saves lives in the short term and knowing that it depends on your contribution is one of the most exciting experiences for a scientist. Many work for years on a drug and never get to see the result, and we see it day by day," she concluded.