Astra antibody cocktail fails to prevent COVID-19 symptoms in large trial (updated)

Celltrion

15/06/2021 07:27

* No reliable results from trial to show prevention of
infections 
    * AstraZeneca has five more ongoing trials 
    * Industry testing range of antibodies

 (Recasts, adds details of antibody therapy, U.S. deal, analyst
quote)
    By Vishwadha Chander and Ludwig Burger
    June 15 (Reuters) - AstraZeneca  AZN.L  said on Tuesday a
late-stage trial failed to provide evidence that its COVID-19
antibody therapy protected people who had contact with an
infected person from the disease, a small setback in its efforts
to find alternatives to vaccines.
    The study assessed whether the therapy, a cocktail of two
types of antibodies, could prevent adults who had been exposed
to the virus in the past eight days from developing COVID-19
symptoms.
     The therapy, AZD7442, was 33% effective in reducing the
risk of people developing symptoms compared with a placebo, but
that result was not statistically significant — meaning it might
have been due to chance and not the therapy.     
    The Phase III study, which has not been peer reviewed,
included 1,121 participants in the United Kingdom and the United
States. The vast majority, though not all, were free of the
virus at the start of the trial.
    Results for a subset of participants who were not infected
to begin with was more encouraging but the primary analysis
rested on results from all participants. 
    "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 Executive Vice President Mene Pangalos said in a
statement.
    The company is banking on further studies to revive the
product's fortunes. Five more trials are ongoing, testing the
antibody cocktail as treatment or in prevention.
    The next one will likely be from a larger trial testing the
product in people with a weakened immune system due to cancer or
an organ transplant, who may not benefit from a vaccine. 
    
    TARGETED ALTERNATIVES
    AZD7442 belongs to a class of drugs called monoclonal
antibodies which mimic natural antibodies produced by the body
to fight off infections.
    Similar therapies developed by rivals Regeneron  REGN.O  and
Eli Lilly  LLY.N  have been approved by U.S. regulators for
treating unhospitalised COVID patients.
    European regulators have also authorised Regeneron's therapy
and are reviewing those developed by partners GlaxoSmithKline
 GSK.L  and Vir Biotechnology  VIR.O  as well as by Lilly and
Celltrion  068270.KS .  urn:newsml:reuters.com:*:nL2N2NK1A6 urn:newsml:reuters.com:*:nL3N2NM2U4
    Regeneron is also seeking U.S. authorisation for its therapy
as a preventative treatment.  urn:newsml:reuters.com:*:nL8N2M526F
    But the AstraZeneca results are a small blow for the drug
industry as it tries to find more targeted alternatives to
COVID-19 inoculations, particularly for people who may not be
able to get vaccinated or those who may have an inadequate
response to inoculations.
    The Anglo-Swedish drugmaker, which has faced a rollercoaster
of challenges with the rollout of its COVID-19 vaccine, is also
developing new treatments and repurposing existing drugs to
fight the virus.
    AstraZeneca also said on Tuesday it was in talks with the
U.S. government on "next steps" regarding a $205 million deal to
supply up to 500,000 doses of AZD7442. Swiss manufacturer Lonza
 LONN.S  was contracted to produce AZD7442.
 urn:newsml:reuters.com:*:nL4N2LE1VJ urn:newsml:reuters.com:*:nL8N2HL6Q5
    Shares in the company were largely unchanged on the London
Stock Exchange.
    The full results will be submitted for publication in a
peer-reviewed medical journal, the company said.

 (Reporting by Vishwadha Chander in Bengaluru; Editing by
Shounak Dasgupta, Kim Coghill and Emelia Sithole-Matarise)
 ((Vishwadha.Chander@thomsonreuters.com; Mobile: +91 7506036802;
Twitter:  https://twitter.com/vishwadha))