GSK Gsk Plc

By Joseph Walker 

GlaxoSmithKline PLC and Vir Biotechnology Inc. said they are advancing their antibody drug into a final-stage clinical trial of Covid-19 patients at high risk of being hospitalized, the latest sign of progress for a promising class of coronavirus treatments.

Vir and Glaxo said Tuesday they expect to have initial study data by the end of this year, and complete results by the first quarter of 2021. If the drug shows a benefit, it could be authorized for early use in the first half of 2021, the companies said.

Glaxo and Vir are among several companies developing monoclonal antibody treatments for Covid-19.

The drugs mimic the natural antibodies produced by the immune system to fight off viruses. Last week, President Donald Trump was given an experimental antibody drug in development by Regeneron Pharmaceuticals Inc.

The drugs have the potential to help treat Covid-19 early in the course of infection and prevent patients from going to the hospital. They are also being studied in hospitalized patients and as a way to prevent infection in people at high risk of catching the virus.

Antibody drugs "could provide an effective and immediate immune response to Covid-19, bypassing the need for our body to produce its own antibodies, which is particularly important in the absence of an effective vaccine," said Dr. Hal Barron, Glaxo's chief scientific officer and president of R&D.

Regeneron and Eli Lilly & Co. are the most advanced in developing antibody drugs and bringing them to market, but multiple treatment options are likely to be needed to meet market demand if they prove successful.

The medicines are difficult to manufacture, and there will likely be limited supplies in the near-term if they are authorized for wider use outside of clinical trials.

In late August, Vir, which is based in San Francisco, and its U.K. partner Glaxo launched a study of their drug -- code-named VIR-7831 -- that combined the last two stages of testing to more quickly determine whether the drug works.

The study was cleared to advance into the final stage of testing, known as Phase 3, after an independent data-monitoring committee evaluated safety data from the Phase 2 portion of the trial and said on Sept. 30 it was fine to go ahead, the companies said.

The Phase 3 study will compare VIR-7831 with a placebo in 1,300 nonhospitalized patients, and evaluate whether the drug can reduce the number of patients who are hospitalized or die within 29 days of entering the trial.

The study will enroll patients in North America, South America and Europe, according to the companies.

The companies said they plan to study the antibody in additional trials to test whether it can benefit hospitalized patients and prevent new symptomatic infections.

Vir's drug is modeled on an antibody taken from a survivor of a previous coronavirus, SARS-CoV, first identified in 2003 and which resembles the new coronavirus called SARS-CoV-2. The drug is designed to bind to a site on the coronavirus and neutralize it, preventing it from reproducing itself and hijacking human tissue.

Regeneron's drug combines two antibodies, one modeled on an antibody taken from a survivor of the new coronavirus, and another derived from mice with genetically engineered immune systems that resemble a human's.

Write to Joseph Walker at joseph.walker@wsj.com

(END) Dow Jones Newswires

October 06, 2020 11:40 ET (15:40 GMT)

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