Merck, Partner Halt Covid-19 Treatment Trial for Hospitalized Patients
April 15 2021 - 7:15AM
Dow Jones News
By Jared S. Hopkins and Betsy McKay
Merck & Co. and its partner Ridgeback Biotherapeutics LP
said they are stopping a trial of their experimental Covid-19 drug
after it failed to help hospitalized patients, delivering another
setback to doctors seeking treatments to use for the disease.
The companies said they would move forward with a separate study
that is testing the oral antiviral drug in treating patients early
in the course of the disease and who are at high risk of Covid-19
complications.
Early study results on hospitalized patients found that the
treatment is unlikely to reduce hospitalization stays and deaths,
the companies said Thursday.
Merck said testing found that the drug, called molnupiravir,
inhibits replication of the virus. But the trial of people who
weren't hospitalized was too small to show that the drug reduced
clinical symptoms during their early treatment, Merck said.
If the drug is proven effective in outpatients after the next,
larger round of testing, Merck could file for an emergency-use
authorization in the second half of this year, the company
said.
"Early treatment is really important," said Roy Baynes, Merck's
chief medical officer and head of global clinical development.
"This could have a big impact if indeed it could reduce the burden
of serious illness."
Researchers didn't observe any serious side effects related to
the drug, Merck said.
Merck and Ridgeback announced the findings after reviewing early
data from a pair of studies testing the drug in hospitalized and
nonhospitalized patients. Results haven't yet been published in a
peer-reviewed scientific journal.
Merck is still looking to play a direct role in responding to
the pandemic after several setbacks. Its two experimental vaccines
failed in testing, and it is helping to manufacture Johnson &
Johnson's vaccine.
If approved by regulators, molnupiravir, which comes in a pill
form, would immediately boost the limited toolbox of treatments for
the disease. Molnupiravir would fill a key role by conveniently
helping people who are sick but not yet hospitalized, potentially
becoming a kind of Tamiflu for the disease.
More than a year into the pandemic, there are still no
easy-to-dispense treatments that can be given to newly diagnosed
patients to prevent them from becoming gravely ill. While vaccines
are rolling out around the world, they remain inaccessible to many
people or are refused by others who could become sick.
Remdesivir, from Gilead Sciences Inc., is the only antiviral
authorized by the Food and Drug Administration and has shown to
provide only a modest benefit for hospitalized patients.
The FDA has also cleared for use three monoclonal-antibody drugs
made by Eli Lilly & Co. and Regeneron Pharmaceuticals Inc. for
people with mild to moderate Covid-19. Yet their use has been
limited, partly because they are given by intravenous infusion,
which can be laborious for hospitals to administer.
In the halted Merck study of about 300 hospitalized subjects,
researchers gave patients one of three doses of molnupiravir, or a
placebo, twice a day for five days and monitored them for about a
month. Molnupiravir reduced replication of the virus in the
patients, but the results still suggested the drug is unlikely to
help them, Merck said.
"The hospitalized patient population typically has been
symptomatic for a lot longer so they're further along in their
illness so it appears that may mitigate against favorable
outcomes," Dr. Baynes said.
Researchers evaluated the same doses in a study of similar-size
groups of people who were sick but not yet hospitalized. They found
the percentage who were hospitalized or died was lower in the more
than 200 subjects who received molnupiravir compared with the 74
people given a placebo, according to Merck.
Merck will test the dose found to have the most potential in a
larger study of 1,850 subjects.
Kenilworth, N.J.-based Merck and Miami-based Ridgeback said they
would also begin another new trial this year studying whether
molnupiravir could prevent infection after people are exposed to
the virus.
The new Merck results build upon earlier findings released in
March that found that the drug significantly reduced infectious
virus in subjects after five days of treatment.
Merck also said Thursday that it would halt development of an
experimental Covid-19 drug it acquired through a $425 million
acquisition of the firm OncoImmune. The drug showed promise in an
early look from a late-stage study, but regulators requested more
clinical data.
Even if proven successful and cleared by regulators, the drug
wouldn't be available until next year because of additional testing
and manufacturing by Merck, Dr. Baynes said.
Write to Jared S. Hopkins at jared.hopkins@wsj.com and Betsy
McKay at betsy.mckay+1@wsj.com
(END) Dow Jones Newswires
April 15, 2021 07:00 ET (11:00 GMT)
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