© Reuters. FILE PHOTO: A patient suffering from COVID-19 receives treatment in the Intensive Care Unit (ICU) for coronavirus disease (COVID-19) at the “Klinikum Darmstadt” clinic in Darmstadt, Germany, on May 20, 2021 REUTERS / Kai Pfaffenbach / File Photo
By Alistair Smout
LONDON (Reuters) – Regeneron Pharmaceuticals Inc’s (NASDAQ 🙂 COVID-19 antibody cocktail reduces deaths in hospitalized patients who have not mounted their own antibody response, a large British study published Wednesday found.
The therapy, REGEN-COV, received emergency use authorization for people with mild to moderate COVID-19 in the United States, but the results of the RECOVERY trial provide the clearest evidence of its effectiveness among hospitalized patients.
It found that antibody therapy reduced the 28-day mortality of people admitted to the hospital with COVID-19 whose immune systems had not mounted an antibody response, known as seronegative, by a fifth.
The result translates to six fewer deaths for every 100 seronegative patients treated with the therapy, the researchers said.
There was no discernible effect of treatment in those who had generated natural antibody responses and were seropositive.
“People have been very, very skeptical that any treatment for this particular virus would work by the time people enter the hospital,” Martin Landray, the trial’s deputy chief investigator, told reporters.
“If you haven’t produced your own antibodies, you really would benefit from getting some,” he said.
The treatment also shortened the hospital stay of those who were seronegative and reduced their chances of needing a mechanical ventilator, Landray said.
Regeneron had previously said that his treatment had shown promise enough in hospitalized patients to warrant continuing his trial. These data provide the first large-scale confirmation of that claim.
There were 9,785 hospitalized COVID-19 patients who were randomly assigned to receive usual care plus antibody combination therapy or just usual care, of which 30% were seronegative.
The RECOVERY trial also showed that the steroid dexamethasone and Roche’s arthritis drug Actemra (tocilizumab) reduced deaths in hospitalized patients.
While those treatments target the inflammation caused by the reaction to the coronavirus, Regeneron’s therapy, which belongs to a class of biotech drugs called monoclonal antibodies, mimics the natural antibodies the body produces to fight infection.
“This is the first time we have one that really targets the virus itself,” Landray said, adding that it could be used in conjunction with the other treatments.
“It’s not that you do one thing or another. These benefits are additive in these patients,” he said.
POSSIBILITY FOR OTHERS
Other companies have been developing similar treatments.
US Emergency Use Authorization has been granted to antibody treatments developed by Eli Lilly (NYSE 🙂 and Co, as well as Vir Biotechnology (NASDAQ 🙂 Inc with GlaxoSmithKline (NYSE 🙂 Plc. Both are approved for use in mild to moderate cases.
On Tuesday, AstraZeneca (NASDAQ 🙂 said its antibody therapy had shown no evidence of protecting people from developing the disease after exposure, although other trials of its cocktail are underway as prevention or treatment.
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 the possibility for many, many others,” he said.
“People see some negative trials and they say ‘well, that will never work’ and they choose not to participate and they go away and do something else. (But) this is very, very clear, the image that we got from this trial.”