GlaxoSmithKline (GSK) and its partner Vir Biotechnology (VIR) announced that they have entered Phase 2/3 clinical trials with their COVID-19 antibody treatment.

According to the companies, the first patient in the study was dosed last week with its VIR-7831 monoclonal antibody treatment. The VIR-7831 is for early treatment of COVID-19 patients who are at high risk of hospitalization, the companies said.

“Treating those with early COVID-19 disease so that it doesn’t become worse is critical both for the patients and for society,” George Scangos, CEO at Vir, said in a statement. “Hospital systems are overwhelmed worldwide, with new infections continuing to strain already limited resources.

“This study is designed to demonstrate whether VIR-7831 can significantly reduce the need for hospitalization in high-risk individuals, such as the elderly or those with pre-existing conditions such as lung or heart disease,” he added.

The study is expected to enroll about 1,300 patients globally who have early symptoms of COVID-19. The study will assess if the VIR-7831 treatment can help to prevent the hospitalization of these patients.

The companies expect initial results of the trial to be available before the end of 2020, with complete results available in the first quarter of 2021. The treatment is also expected to have potential early access to the public in the first half of 2021.

“Monoclonal antibodies directed against the SARS-CoV-2 virus 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,” Dr. Hal Barron, chief scientific officer and president R&D at GlaxoSmithKline, said in a statement.

“This study will assess the ability of VIR-7831 to prevent high-risk individuals from progressing to severe disease, and in future studies we will also test the antibody’s ability to prevent infection in high-risk patients and to reduce disease severity in patients who are already hospitalized,” Barron said.

GlaxoSmithKline and Vir formed a partnership for the development of the VIR-7831 antibody treatment in April.

Shares of GlaxoSmithKline were trading at $39.64 as of 10:26 a.m. EDT, up 4 cents or 0.09% while shares of Vir Biotechnology were trading at $40.41, down $1.23 or 2.95% at the same time.

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