Hanya Gaber
Monoclonal Antibodies, a promising treatment for COVID-19? According to Regeneron Pharmaceuticals, the American biotechnology company, the end of this pandemic is nearly upon us.
Hopefully, if clinical trials are successful, an antibody cocktail will be available for the public to use in order to combat COVID-19 and as prophylaxis against COVID-19 as well as SARS-COV-2.
A notable recipient of the treatment is former president of the United States, Donald Trump. President Trump has spoken very highly of the treatment, multiple times, in spite of the many health professionals and enthusiasts, such as Bill Gates -the co-founder of Microsoft Corporation, continuously arguing that it does not classify as a “cure”.
In this article, we shall discuss the science behind this treatment, the clinical trials held, and the aspects the treatment is lacking.
As mentioned on Regeneron’s official website, the company has experimented the use of monoclonal antibodies to combat the virus on human cases after successful tests on genetically-engineered rats.
They have chosen to use a combination of two potent antiviral antibodies -REGN10933 and REGN10987- forming the REGN-COV2 antibody, which they extract from human COVID-19 survivors. Each antibody targets a different part of the virus spike protein, to ensure effectiveness, even if the virus mutates.
The antibody cocktail has proven to be successful in reducing the viral load in a test sample of 275 non-hospitalized COVID-19 patients, alleviating the associated symptoms, as well as reducing the number of medical visits by the study group. It’s only fair to mention that 3 patients who received the antibody experienced serious adverse effects.
In the subsequent trials, more COVID-19 cases will be recruited and monitored. In addition, phase 3 clinical trials will be conducted on contacts of the infected individuals to assess the prophylactic properties of the antibody combination therapy.
Other parallel ongoing trials include experimenting the use of REGN-COV2 in the treatment of hospitalized patients, as part of a larger program. According to George D. Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief Scientific Officer of Regeneron, the company is running simultaneous trials in order to move as fast as possible amidst the ongoing pandemic.
Despite the promising results, the REGN-COV2 antibody is still under investigation, and trial phases have yet to take place; safety and efficacy have yet to be fully evaluated by regulatory authorities.
A request has been submitted to the US Food and Drug Administration for Emergency Use Authorization (EUA). Should the EUA be granted, REGN-COV2 antibody therapy will be available for public use and distributed worldwide through a collaboration between Regeneron and Roche Pharmaceuticals.
Nonetheless, as reported by The Atlantic, the rate at which Regeneron is producing doses of the REGN-COV2 antibody combination does not meet the rising number of COVID-19 cases, solely within the USA.
Regeneron at this time has produced doses to cover 50,000 patients, expecting to have doses available for 300,000 patients, in total, within the next few months. With COVID-19 cases showing a rise of approximately 50,000 cases per day in the USA alone, the number of doses expected for production over the next months will not have a major impact.
This sheds the spotlight on an issue that still lingers: Even with successful trials and the required authorization, the anticipated doses might not qualify as the savior the world awaits.
On a brighter note, Regeneron Pharmaceuticals has already been successful in producing monoclonal antibodies against Ebola virus, which have proven to be largely effective.
The previous success with Ebola leaves the world with hope that the Corona virus pandemic can be controlled by the introduction of the REGN-COV2 antibody combination into the COVID-19 treatment and its prophylaxis regimens.
References
https://www.nytimes.com/2020/10/12/health/coronavirus-monoclonal-antibodies-trump.html
https://www.sciencemag.org/news/2020/09/provocative-results-boost-hopes-antibody-treatment-covid-19
https://www.bbc.com/news/health-54120753
https://pubmed.ncbi.nlm.nih.gov/32134278/
http://apjai-journal.org/wp-content/uploads/2020/03/2.pdf
https://investor.regeneron.com/news-releases/news-release-details/regenerons-regn-cov2-antibody-cocktail-reduced-viral-levels-and
https://www.regeneron.com/covid19
https://investor.regeneron.com/news-releases/news-release-details/two-science-publications-highlight-potential-regn-cov2-anti
https://science.sciencemag.org/content/369/6506/1010
https://www.prnewswire.com/news-releases/regenerons-regn-cov2-antibody-cocktail-reduced-viral-levels-and-improved-symptoms-in-non-hospitalized-covid-19-patients-301140336.html
https://investor.regeneron.com/index.php/news-releases/news-release-details/regeneron-announces-start-regn-cov2-phase-3-covid-19-prevention
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