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Two Therapies Dropped from NIH Covid-19 Trial

SARS-CoV-2 and cell

Scanning electron microscope image shows SARS-CoV-2 viruses emerging from the surface of cells cultured in the lab. (NIAID, NIH)

5 Mar. 2021. A clinical trial testing multiple treatments for people hospitalized with Covid-19 infections is dropping two therapies for not meeting efficacy standards. The Activ-3 trial sponsored by National Institute of Allergy and Infectious Diseases or NIAID, part of National Institutes of Health, removed from the trial synthetic antibody treatments made by Brii Biosciences in Durham, North Carolina and Beijing, and Vir Biotechnology in San Francisco.

The trial is part of NIH’s Accelerating Covid-19 Therapeutic Interventions and Vaccines, or Activ, program to streamline and coordinate actions to combat the Covid-19 pandemic among agencies in the U.S. government, private pharmaceutical and biotech companies, international agencies, and not-for-profit groups. Among Activ’s goals is to accelerate evaluation of vaccine and therapy candidates to speed regulatory approval, including clinical trials of experimental drugs.

Activ-3 is enrolling 10,000 participants at 78 sites worldwide hospitalized with Covid-19 disease, to test safety and efficacy of several therapies. The trial uses an adaptive design that allows for changing the course of the study while underway, without compromising gold-standard quality of the efficacy or safety data. Adaptive trials are usually governed by a single governing board and master protocol spelling out ground rules for the study, including standards and processes for assessing results, adding or closing sample groups, and adding new drugs or devices for testing.

As reported by Science & Enterprise in December 2020, Activ-3 under its master protocol, added a combination of two synthetic antibodies made by Brii Bio, code-named BRII-196 and BRII-198, designed to neutralize SARS-CoV-2 viruses, while reducing the risk of antibody-dependent enhancement, an unintended consequence that makes it easier for the original viruses to infect cells.

The study also added Vir Biotech’s synthetic antibody code-named VIR-7831, licensed to drug maker GlaxoSmithKline. Vir Biotech creates synthetic antibodies that work like natural, but often rare, antibodies produced by people who recover from infections, in this case from SARS-CoV-2 viruses responsible for Covid-19.

Not meeting pre-defined efficacy criteria

Brii Bio says in a statement that Activ-3’s independent data and safety monitoring board reviewed the first phase of data from 343 participants randomized to receive either the BRII-196/BRII-198 combination or a placebo. The board found findings from these participants on five ordinal rating scales indicate recipients of the synthetic antibodies did not meet the pre-specified effiacy criteria for continuing the trial.

A comparable review of 344 participants by the Activ-3 board found VIR-7831 also did not meet pre-specified effiacy criteria for continuing the trial. NIAID says in a statement that initial findings show VIR-7831 with clinical benefits, but placebo recipients in the trial were in a more advanced disease state than VIR-7831 recipients, and after adjustments in the data, those initial gains were erased.

The initial data did not indicate any safety issues with either therapy. The Activ-3 trial continues testing an experimental long-acting antibody combination code-named AZD7442, developed by drug maker AstraZeneca in Cambridge, U.K. The study’s data and safety monitoring board plans to review initial data for that therapy candidate once findings from 300 participants are collected.

Vir Biotech says two mid- and late-stage clinical trials continue to test VIR-7831 among non-hospitalized patients with mild to moderate forms of Covid-19. And the Activ-2 trial, sponsored by NIAID, is testing the BRII-196/BRII-198 combination therapy, also among non-hospitalized Covid-19 patients.

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