Regeneron’s Antibody Therapy Reduces Deaths in Some Hospitalized COVID-19 Patients – Study

  • The therapy reduced deaths in the seronegative patients by a fifth
  • Can be used in combination with other treatments
  • Finding good signs for other antibody treatments

LONDON, June 16 (Reuters) – A COVID-19 antibody cocktail developed by Regeneron Pharmaceuticals Inc (REGN.O) and Roche (ROG.S) reduced deaths in hospitalized patients whose own immune systems failed to produce a response, a major British study found on Wednesday.

The therapy, REGEN-COV, has received emergency use approval in the United States for people with mild to moderate COVID-19, but the results of the RECOVERY study provide the clearest evidence of its effectiveness in hospitalized patients.

It found that antibody therapy reduced the 28-day mortality by a fifth of people hospitalized with COVID-19 whose immune systems had not elicited an antibody response, known as seronegative.

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The result translates into six fewer deaths for every 100 seronegative patients treated with the therapy, the researchers said.

There was no discernible effect of the treatment on those who had generated natural antibody responses.

“People were very, very skeptical that a treatment for this particular virus would work if people were hospitalized,” Martin Landray, the trial’s joint chief investigator, told reporters.

“If you haven’t grown your own antibodies, you would really benefit from getting some,” he said.

The treatment also shortened the seronegative patients’ hospital stay and reduced their likelihood of needing a mechanical ventilator, Landray said.

Regeneron had previously said its treatment in hospitalized patients was promising enough to warrant continuing its study. These data provide the first large-scale confirmation of this claim.

There were 9,785 patients hospitalized with COVID-19 who were randomly assigned to usual care plus antibody combination therapy or usual care only, of whom 30% were seronegative.

The RECOVERY study also showed that Roche’s (ROG.S) steroid dexamethasone and arthritis drug Actemra (tocilizumab) reduced deaths in hospitalized patients.

While these treatments focus on inflammation caused by the response to the coronavirus, Regeneron’s therapy, which belongs to a class of biotech drugs called monoclonal antibodies, mimics natural antibodies the body produces to fight off infection .

Regeneron Pharmaceuticals’ corporate logo is seen on a building at the company’s Westchester campus in Tarrytown, New York, the United States, September 17, 2020. REUTERS/Brendan McDermid/File Photo

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“This is the first time we’ve had one that actually targets the virus itself,” Landray said, adding that it could be used alongside the other treatments.

“It’s not like you’re doing one or the other. Those benefits add up in these patients,” he said.

POSSIBILITY FOR OTHERS

Other companies have developed similar treatments.

Emergency Use Authorization has been granted for antibody treatments developed by Eli Lilly and Co (LLY.N) and Vir Biotechnology Inc (VIR.O) with GlaxoSmithKline Plc (GSK.L). Both are approved for use in mild to moderate cases.

On Tuesday, AstraZeneca (AZN.L) said its antibody therapy had shown no evidence protecting people from developing the disease after exposure, although other trials of its cocktail as prevention or treatment are underway.

Landray said the RECOVERY results should give developers of other monoclonal antibody therapies optimism that they can also be used in some hospitalized patients.

“This opens up the possibility for many, many others,” he said.

“People see some negative studies and say, ‘Well, that’s never going to work,’ and they get off and go and do something else. (But) that’s very, very clear, the picture we got from this study.”

Regeneron has commissioned the Swiss pharmaceutical company Roche to manufacture the drug.

Some warned that the drug’s full cost-benefit ratio would not be clear until more details of the study became available.

“The absolute magnitude of the benefit in mortality is not large, and it means that a large (potentially 20) number of people need to be treated with the extremely expensive drug to prevent a single death,” said Stephen Evans, professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine.

“If (patients) can be easily identified and treated, then there is some benefit in practice, but its benefits should not be overstated.”

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Reporting by Alistair Smout Editing by Bill Berkrot

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