Phase 3 Trial Begins of COVID-19 Antibody Treatment for Immune Suppressed People

Peter Russell

November 21, 2020

A UK patient will today become the first in the world to join a trial to test whether AstraZeneca's long-acting antibody (LAAB) combination, AZD7442, will prevent COVID-19 for up to a year.

The phase 3 trial will recruit 5000 participants globally to evaluate the safety and effectiveness of LAAB.

The treatment, specifically designed for immunosuppressed patients, consists of a pair of monoclonal antibodies (mAbs) derived from convalescent patient samples that are highly potent.

They work by binding to two different epitopes on the SARS-CoV-2 spike protein.

The mAbs have an extended half-life, engineered using proprietary technology, to extend longevity in the body.

Two key members of the trial team briefed journalists on the antibody combination treatment in a seminar hosted by the Science Media Centre.

Protection Could Last Up to 12 Months

"We think they will confer protection for between 6 but more likely closer to 12 months, which makes them in effect almost like a passive vaccination," said Sir Mene Pangalos, head of research and development at the British-based pharmaceutical company.

In total, there will be around nine sites in the UK taking part in the Provence study with 1000 patients.

Participants will be a mixed group, said Prof Andrew Ustianowski, principal clinical research lead at North Manchester General Hospital. "Some people will be those who are immunosuppressed or may have intolerance or contraindications to having vaccination. The other groups are those that are potentially at high risk of exposure, which may include healthcare staff and others."

Researchers also aim to enrol people in care and residential homes.

'Attractive Cocktail'

Kate Bingham, chair of the Vaccines Taskforce, described the inclusion of two antibodies in the treatment as "the most attractive cocktail" and a protection against resistant strains of the SARS-CoV-2 virus.

LAABs mimic natural antibodies. They have the potential to treat and prevent disease progression in patients already infected with the virus, as well as to be given as a preventative intervention prior to exposure to the virus.

The treatment is likely to be expensive, although Sir Mene Pangalos declined to put a figure on it at this stage.

However, he pointed out that while any coronavirus vaccine could be manufactured in billions, "we'll be able to make in the region of three to four million doses" of AZD7442.

Initial results from the phase 3 trial are expected in the first quarter of 2021.

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