AstraZeneca Begins Phase I Trial of COVID-19 Antibody Drug

On Tuesday, August 25, 2020, a United Kingdom (UK)-based drug maker, AstraZeneca PLC (AstraZeneca) announced that it has started a Phase I clinical trial of its newly produced drug, known as AZD7442, to help prevent and treat COVID-19. The trial is aimed to evaluate the safety, tolerability, and efficacy of the drug by performing a test of up to 48 healthy volunteers between the age group of 18 to 55 in the UK.

The British pharmaceutical group said in a statement that the first participants have started receiving doses of AZD7442, a combination of two monoclonal antibodies (mAbs) for the trial. The drug, which is widely considered to be a potential COVID-19 vaccine, is developed by the company in collaboration with scientists at Oxford University.

AstraZeneca’s Phase I trial

AstraZeneca is one of the world’s leading companies, which is actively engaged in the global search for finding a vaccine for the coronavirus disease. The company’s approach of using mAbs, which represents natural antibodies generated in the body to fight off infection, to target the virus has been recommended by leading scientists. Several pharmaceutical groups including Regeneron (REGN.O), Eli Lilly (LLY.N), Roche (ROG.S), and Molecular Partners (MOLN.S) have already tested the development of mAbs for the disease treatment.

Reflecting the Phase I trial, AstraZeneca’s executive vice president of biopharmaceuticals R&D, Mene Pangalos stated, “This trial is an important milestone in the development of our monoclonal antibody combination to prevent or treat COVID-19. This combination of antibodies, coupled to our proprietary half-life extension technology, has the potential to improve both the effectiveness and durability of use in addition to reducing the likelihood of viral resistance.”

The group said if the early-stage trial showed a positive result among the participants, the drug would proceed for the next test to evaluate whether it could be used as a preventive treatment for healthy people or medicine for treating COVID-19 infected patients or both.

AstraZeneca’s Drug Manufacturing

According to the company’s report, “AZD7442 is a combination of two mAbs derived from convalescent patients with SARS-CoV-2 infection.” The company received a license in June 2020 and optimized the mAbs with half-life extension and reduced Fc receptor binding.

US infectious diseases expert, Anthony Fauci praised the development and initiative taken by the pharmaceutical group. Fauci even called the establishment of the drug as “almost a sure bet” for the treatment of COVID-19. With this development, last week the US President Donald Trump and his administration were considering a fast-tracked approval of AstraZeneca’s COVID-19 vaccine before the Presidential election of November. For this, AstraZeneca had received $23.7 million in June from US government agencies to advance the development of antibody-based treatments for COVID-19.

In the same month, AstraZeneca and Catalent entered into a deal for producing “hundreds of millions of doses” of the vaccines for the COVID-19 treatment between this month and March 2022. The British drugmaker signed agreements with Biomedical Advanced Research and Development Authority (BARDA) and Defense Advanced Research Projects Agency (DARPA) in the US and new agreements with companies to double its production from one billion doses to two billion doses.