Monday, December 20, 2021

Trials to begin in UK for Covid antibody cocktail drug treatment

Major trials will begin this weekend of an antibody cocktail that scientists hope will protect people against Covid-19 and could be swiftly used in care homes or on cruise ships in the event of an outbreak.

A UK volunteer will be given the first dose of a drug that is expected to give vulnerable people immediate protection. The jab into the muscle of the arm takes effect straight away and could last for six months to a year. If it works as well as scientists predict, it could be used to protect those who cannot be given vaccines because of their state of health.

The drug, which is moving into large-scale phase 3 trials in the UK, is made by AstraZeneca, the same pharmaceutical company that has partnered with Oxford University to develop a vaccine. The Oxford/AstraZeneca vaccine is the UK government’s biggest hope for a mass vaccination campaign next year. The UK has pre-ordered 100m doses but unlike rival vaccination trials from Pfizer/BioNTech and Moderna, the company has not yet published any efficacy results.

Asked whether the vaccine would be ready to use by the end of 2020, Sir Mene Pangalos, executive vice president of biopharmaceuticals R&D at AstraZeneca, said: “We are on track to still have data before the end of the year or before Christmas. I think we’re still hoping that we might be able to dose, if we show that the vaccine is safe and effective, towards the end of the year.”

Pangalos said the antibody drug would be almost like a passive vaccination. “Now that’s important because obviously there’s going to be a significant number of people even in a world where vaccines are highly effective that will not respond to vaccines, or in fact will not take vaccines and so having monoclonal antibodies as potential therapeutics I think is also important.”

Monoclonal antibodies are produced in the lab and can enhance the response of the immune system to an invading virus. The phase 3 trial launching at the weekend will recruit 5,000 patients globally to evaluate the safety and effectiveness of the long-acting antibodies. There will be nine sites in the UK with 1,000 patients, half of whom will have the trial drug and the other half a placebo.

The UK trial will test whether the drug is protective for people without Covid infection. Later trials will look to see whether it can help in an outbreak in a care home, before anyone knows whether they are infected. It will also be tested at a later date as a treatment in early stage Covid disease.

Kate Bingham, head of the UK vaccines taskforce, said the drug was “part of our portfolio to protect the whole UK”. The UK has a provisional order for 1m doses.

Vaccines typically take six weeks to work and but this would protect people immediately.

“Vaccines work in people who have a functional immune system and if you’re immunosuppressed and you’re going through bone marrow transplants or treatments that actually reduce your ability to mount an immune response, then this is basically the only current way of providing that short term passive immunity,” she said.

The cost, however, is high. Two companies, Regeneron and Eli Lilly, that have produced antibody cocktails for treating people in hospitals, set their prices at $600 (£451) to $1,000 a dose. The numbers of people who would be given the antibody cocktail instead of a vaccine were relatively small, said Pangalos. “It’s millions of doses, versus billions,” he said.

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