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 Findings from a mid-stage clinical trial involving 584 patients
showed on Wednesday the experimental drug tezepelumab reduced the
annual rate of serious asthma attacks, known as exacerbations, by
between 61 and 71 percent, depending on dose.
The results could put the first-in-class injection in a strong
position in a competitive market as it heads into final-stage Phase
III tests later this year or early next.
"Tezepelumab appears to be the broadest and most promising biologic
for the treatment of persistent uncontrolled asthma to date,"
Elisabeth Bel of Amsterdam's Academic Medical Center wrote in an
editorial in the New England Journal of Medicine.
Still, she cautioned researchers needed to confirm its safety
profile in larger trials, since there was a potential risk its
impact on the immune system might lead to infections.
Shares in AstraZeneca rose 1 percent on Thursday following the news,
with Barclays analysts citing it as an example of the strength of
the drugs pipeline beyond cancer, which will be in focus at a
medical meeting in Madrid this weekend.
Injections for severe asthma have opened up a multibillion-dollar
market as competing drugmakers have raced to develop antibody-based
medicines for the 15 percent or more of patients who do poorly even
on the latest inhalers.
Despite treatment advances in recent decades, their asthma is still
not well controlled by standard therapy, which consists of inhaled
steroids and drugs to open the airways.
Nucala and Teva's Cinqair are two recently approved new injectable
drugs and AstraZeneca's benralizumab is likely to join them soon,
since it is awaiting approval in the fourth quarter of this year.
Sanofi's Dupixent, already approved for severe eczema, is a bit
further behind but is widely seen as a strong contender.
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However, all these new medicines only appear to help people with
certain types of severe asthma, by targeting specific inflammatory
chemicals made in the body that drive asthma, making them suitable
for subgroups of patients.
Tezepelumab is different because it acts further upstream in the
inflammatory cascade responsible for asthma by blocking the action
of a cell-signalling protein called thymic stromal lymphopoietin (TSLP).
That means it can help a wider range of patients and could be a
"game-changer", according Tom Keith-Roach, head of AstraZeneca's
respiratory, inflammation and autoimmune business.
Biotech drugs for severe asthma are already worth $2 billion in
annual sales and Keith-Roach believes there is significant scope for
growth since currently only about 10 percent of patients who might
benefit are getting them.
Tezepelumab, like Dupixent, is also being developed for eczema.
The results of the Phase IIb asthma study, which were published
online by the New England Journal of Medicine, will also be
presented at the European Respiratory Society annual meeting in
Milan next week.
(Reporting by Ben Hirschler; Editing by Mark Potter)
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