Study hints drug may cut virus hospitalizations
A drug company says that partial results from a study testing an antibody drug give hints that it may help keep mildtomoderatelyillCOVID19 patients from needing to be hospitalized, a goal no current coronavirus medicine has been able to meet.
Eli Lilly announced the resultsWednesday in a press release, but they have not been published or reviewed by independent scientists.
The drug missed the study’smaingoalof reducing the amount of virus patients hadafter11days, exceptatthe middle of three doses being tested. However, most study participants, eventhosegiven a placebo treatment, had cleared the virus by then, so that time point now seems too late to judge that potentialbenefifififififit, thecompanysaid.
Othertestssuggestthedrug was reducing virus sooner, andthe results areanencouraging “proof of principle” as this and other studies continue, Lilly said.
Thecompanysaiditwould talk with regulators about possiblenext steps but that it was too soon to speculate on whether these interimresults might lead to any action to allow early use.
“I’mstrongly encouraged” by the results, saidDr. Myron Cohen, aUniversity ofNorth Carolina virologist. He had no role in the Lilly study but helps direct antibody studies for a public-private research group the federal government formed to speed testing of these drugs.
“This seems to demonstrate what we thought” — that such drugs would give a benefifit, he said.
Antibodies areproteins the body makes when an infection occurs; they attach to a virus and help it be eliminated. Thebloodof survivors is being tested as a treatment forCOVID-19patientsbecause it contains such antibodies, but the strength and types of antibodies varies depending oneachdonor, anddoingthis onalargescale isimpractical.
The drugs that Lilly and other companies are testing are concentrated versions of specifific antibodies that worked best against the coronavirus in lab and animal tests, and can be made in large, standardized doses.
They are being tested to treatnewlydiagnosedCOVID19 patients in hope of preventing serious disease or death, and to try to prevent infection in people at high risk of that such as nursing home residents and health workers.
Wednesday’s results come from 450 people in a midstage study testing an antibody jointly developed by Indianapolis-based Lilly and theCanadiancompanyAbCellera in people with COVID19 symptoms not severe enough to warrant hospitalization. The drug is given once through an IV and was tested at threedoses. Neither the patients nor their doctors knew which patients received the drug orplacebo infusions.
HospitalizationorERvisits occurred in 1.7%, or 5 of 302 patients given the drug and 6% or 9 of 150 of those given placebo. The company did not disclose whether those resultsmet scientifific tests to rule out that they could have occurred by chance alone.
The company felt that giving the actual numbers “told the story in the most balanced way,” said Lilly’s chief scientifific offifficer, Dr. Daniel Skovronsky.
The difffffffffffference seemslarge enough to suggest a true benefifit and the result is “promising” even though the study missed itsmaingoal, said Dr. Peter Bach, a health policy expert atMemorialSloanKettering Cancer Center in New Yorkwithnorole inthestudy.