(Gerd Altmann, Pixabay)
18 Dec. 2020. A clinical trial conducted by National Institutes of Health is evaluating two more synthetic antibodies as treatments for patients hospitalized with Covid-19 infections. The late-stage, large-scale trial known as Activ-3 is designed to allow adding or changing treatments in mid-stream, in this case adding tests of experimental antibody treatments among patients needing to be hospitalized because of their infections.
The clinical 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.
The Activ-3 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. With these common rules, standards, and practices in place, adaptive trials make it possible to evaluate drugs and devices quicker, add new population groups to a study, or close treatment interventions if needed, even as data are being collected.
Under its master protocol, Activ-3 is adding a synthetic antibody code-named VIR-7831 developed by Vir Biotechnology in San Francisco and licensed to drug maker GlaxoSmithKline in London. Vir Biotech’s technology creates synthetic antibodies that work like natural, but often rare, antibodies produced by people who recover form infections, in this case from SARS-CoV-2 viruses responsible for Covid-19. The company’s antibodies are designed to neutralize pathogens or stimulate the immune system, in some cases both.
Activ-3 is also adding a combination of synthetic antibodies developed by Brii Biosciences, in Durham, North Carolina and Beijing. The two antibodies, code-named BRII-196 and BRII-198, are 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.
For this part of Activ-3, the study team is first enrolling 450 patients hospitalized with mild to moderate Covid-19 infections, and experiencing symptoms for no more than 13 days. These participants are randomly assigned to receive VIR-7831, BRII-196/198, or a placebo, with researchers assessing the volunteers’ conditions after five days on a rating scales ranging from undertaking normal activities to death.
Once the first results show the treatments’ safety and effectiveness, the study team will add 1,050 patients, including those with more serious symptoms. As before, this larger group will be randomly assigned to receive VIR-7831, BRII-196/198, or a placebo. The researchers in this case are looking primarily for indicators of a sustained recovery, defined as discharge from the hospital and living at home for 14 consecutive days. The study team also plans a follow-up after 90 days.
As reported by Science & Enterprise in October, Activ-3 trial results can reveal therapies that don’t work as well as those that may succeed. Drug maker Eli Lilly and Co. ended participation in Activ-3 testing bamlanivimab, its synthetic antibody treatment for Covid-19 infections among hospitalized patients. Those findings showed bamlanivimab offers little clinical value to hospitalized patients, although other trials of the antibody among non-hospitalized patients, and residents and staff in long-term care facilities are continuing.
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