* Antibody combo 77% effective in preventing COVID-19
* New hope for immunocompromised with low vaccine protection
* AstraZeneca pursuing initial approval well before year-end
(Adds further development, expected review, strategic
implications)
By Ludwig Burger
Aug 20 (Reuters) - AstraZeneca's new antibody
therapy reduced the risk of people developing COVID-19 symptoms
by 77% in a late-stage trial, putting the drugmaker on track to
offer protection to those who respond poorly to vaccines.
The company said on Friday that 75% of the participants in
the trial for the therapy - two types of antibodies discovered
by Vanderbilt University Medical Center - had chronic conditions
including some with a lower immune response to vaccinations.
Similar therapies made with a drug class called monoclonal
antibodies which mimic naturally occurring immune system
proteins are being developed by Regeneron, Eli Lilly
and GlaxoSmithKline with partner Vir.
But AstraZeneca is the first to publish positive COVID
prevention data from an antibody trial.
The good news on the therapy was tempered, however, by a
separate AstraZeneca statement https://www.astrazeneca.com/media-centre/press-releases/2021/update-on-ultomiris-phase-iii-als-trial.html
on Friday.
It said a trial of a treatment for the rare neurological
disorder amyotrophic lateral sclerosis (ALS), developed by
AstraZeneca's newly acquired Alexion, had been stopped early due
to a lack of efficacy.
AstraZeneca executive Mene Pangalos said the therapy trial
results were taken three months after the antibodies were
injected and investigators would follow up as far out as 15
months in the hope the company can tout the shot as a year-long
shield.
Pangalos signalled that the prospects of a new COVID-19
product in AstraZeneca's medicine cabinet could also enhance the
strategic value of its existing vaccine Vaxzevria, which it
developed in collaboration with Oxford University.
"No other company has delivered two molecules against
SARS-CoV2. This definitely helps us in positioning us in terms
of COVID," Pangalos told Reuters. SARS-CoV2 is the scientific
name for the coronavirus that causes COVID-19.
Another leading AstraZeneca executive, Ruud Dobber, had said
last month that different strategic options were being explored
for AstraZeneca's vaccine operations, which have faced a string
of challenges.
APPROVAL TARGETS
The Anglo-Swedish drugmaker has suffered production problems
during the rollout of Vaxzevria while very rare cases of blood
clotting have weighed heavily on demand for the shot in Europe.
The vaccine has also yet to win clearance in the United States.
Concerns over the new Delta variant and waning vaccine
efficacy have prompted several high-income countries to offer a
third vaccine shot on top of the usual two-shot regimen to the
immunocompromised and other groups at risk.
The immunocompromised, such as those with organ transplants
or in cancer care, make up about 2% of the population and would
be the main target group for the new therapy. Naval forces on
missions could also benefit, among others, Pangalos said.
Even though only 12% to 13% of the trial volunteers were
vaccinated when the therapy trial data was generated,
AstraZeneca will seek to position the shot as a top-up to
previous inoculations.
Pangalos said AstraZeneca was targeting conditional approval
in major markets for the therapy well before year-end and that
roughly 1 to 2 million doses would be produced by then.
Any bulk supply contracts would prompt the company to boost
production, with one or two manufacturing sites at as-yet
undisclosed locations serving world demand, he said.
(Additional Reporting by Muvija M in Bengaluru; Editing by
Sriraj Kalluvila, Jason Neely and David Clarke)
Glaxosmithkline (GSK)
Astrazeneca (AZN)