AstraZeneca's Covid-19 Drug Fails to Meet Primary Goal in Trial -- Update
15 Juni 2021 - 12:50PM
Dow Jones News
--AstraZeneca said AZD7442 didn't meet primary target in a Phase
3 trial
--Drug didn't achieve a statistically significant prevention of
symptomatic Covid-19 after exposure to the virus
--Company observed protection against virus in patients who
tested negative in PCR test
By Adria Calatayud
AstraZeneca PLC said Tuesday that a Phase 3 trial to assess the
safety and efficacy of a long-acting antibody combination, called
AZD7442, for the prevention of symptomatic Covid-19 after exposure
didn't meet the primary goal.
The Cambridge, U.K.-based pharmaceutical company said that
AZD7442, developed with support from the U.S. government, reduced
the risk of developing symptomatic Covid-19 in unvaccinated adults
with confirmed exposure to a person with a case of the SARS-CoV-2
virus within the past eight days by 33% compared to a placebo,
which wasn't statistically significant.
However, the drug reduced the risk of developing symptomatic
Covid-19 by 73% in participants who tested negative in a polymerase
chain reaction, or PCR, test at time of dosing, AstraZeneca said.
In patients who were PCR negative, AZD7442 reduced the risk of
developing symptomatic Covid-19 by 92% compared to a placebo more
than seven days after dosing, and by 51% up to seven days after
dosing, the company said.
Myron J. Levin, professor of Pediatrics and Medicine at the
University of Colorado School of Medicine and principal
investigator on the trial, said results from the study suggest that
the drug might be useful in preventing symptoms in individuals not
already infected.
The trial, which was conducted in the U.K. and the U.S. with
1,121 participants, showed that the drug was well-tolerated,
AstraZeneca said. Full results from the trial will be submitted for
publication in a peer-reviewed medical journal and presented at a
forthcoming medical meeting, it said.
"While this trial did not meet the primary endpoint against
symptomatic illness, we are encouraged by the protection seen in
the PCR negative participants following treatment with AZD7442,"
AstraZeneca's BioPharmaceuticals R&D Executive Vice President
Mene Pangalos said.
AZD7442 is a cocktail of tixagevimab and cilgavimab, two
long-acting antibodies derived from cells donated by convalescent
patients after being infected with the coronavirus that causes
Covid-19. The drug was discovered by Vanderbilt University Medical
Center and licensed to AstraZeneca in June 2020.
The drug is being tested in two additional Phase 3 trials for
Covid-19 prevention and treatment. The company on April 30 said
that it expected first data from the first of those trials, to
evaluate the efficacy of the drug for treatment of Covid-19 in
nonhospitalized patients, by the end of June.
First data from another AZD7442 trial to assess its safety and
efficacy in adults who are at increased risk for coronavirus
infection due to living or work situations, or who are at increased
risk of responding inadequately to vaccines is expected in the
second half of the year, AstraZeneca said.
The company in March said that it had extended an agreement with
the U.S. government to supply up to 500,000 additional doses of
AZD7442 for $205 million, taking the total potential U.S. supply to
700,000, contingent on AZD7442 receiving emergency-use
authorization from the U.S. Food and Drug Administration.
Discussions with the U.S. government regarding next steps are
continuing, AstraZeneca said.
The company, which has developed a Covid-19 vaccine in
collaboration with the University of Oxford, has also evaluated the
potential of some of its medicines to treat coronavirus infections,
but those trials failed to meet their goals.
In November, AstraZeneca said that its Calquence oncology drug
didn't meet the primary efficacy goal in Phase 2 trials. In April,
the company said that a Phase 3 trial to assess the potential of
its Farxiga diabetes drug to treat patients with Covid-19 at risk
of developing serious complications didn't achieve statistical
significance for its primary targets of prevention and
recovery.
Write to Adria Calatayud at adria.calatayud@dowjones.com
(END) Dow Jones Newswires
June 15, 2021 06:44 ET (10:44 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
AstraZeneca (NASDAQ:AZN)
Historical Stock Chart
Von Jun 2024 bis Jul 2024
AstraZeneca (NASDAQ:AZN)
Historical Stock Chart
Von Jul 2023 bis Jul 2024