by Phil Taylor | Aug 31, 2018
Despite encouraging
midstage data for AstraZeneca’s drug for systemic lupus erythematosus (SLE),
anifrolumab has missed the target in the first of two ongoing phase 3 trials,
putting its future in doubt.
The antibody, which
binds to and inhibits the subunit 1 of the type I interferon receptor and is
designed to dampen down the activity of inflammatory cytokines, was unable to
achieve a significant reduction in disease activity compared to placebo over the
one-year TULIP 1 trial.
AZ isn’t making a
decision on its future just yet, as a second study—called TULIP 2—is still
being run and is due to deliver results before the end of the year. However,
the company’s terse statement on the disappointment
suggests prospects are looking bleak.
autoimmune disease
with significant unmet need among patients who struggle to achieve meaningful
disease control,” said AstraZeneca Chief Medical Officer Sean Bohen. “The
result of this trial is disappointing for patients and the lupus community.”
Anifrolumab is also in
two midstage trials, one looking at a subcutaneous formulation and another
zeroing in on kidney damage caused by lupus. If it turns out to be defunct, the
failure strips out a big chunk of AZ’s clinical pipeline of drugs for
autoimmune diseases, which is otherwise headed by phase 2 Sjogren’s syndrome
candidate prezalumab, and leaves the company ever more dependent on its core
respiratory, cardiovascular/metabolism and cancer assets.
TULIP 1 recruited
adult patients with moderate-to-severe SLE who were given one of two doses of
anifrolumab (150mg or 300mg) or placebo by intravenous infusion every four
weeks. The design of TULIP 2 is very similar but is pitting only the 300mg dose
against the control group.
For AstraZeneca, news
of the disappointing data comes shortly after it announced another trial
failure for MEK 1/2 inhibitor selumetinib in thyroid cancer after
an earlier miss in non-small cell lung cancer, the termination of phase 3
trials for its Eli Lilly-partnered BACE inhibitor lanabecestat for Alzheimer’s disease,
and setbacks for atopic dermatitis candidate tezepelumab and asthma drug tralokinumab.
It’s a big
disappointment for AZ, which at one time was pitching anifrolumab as a
potential rival to GlaxoSmithKline’s subcutaneous formulation of Benlysta
(belimumab), an antibody approved for SLE in 2011 with sales of around $275
million in the first half of this year. The company previously said anifrolumab
was a blockbuster prospect when the pharma
giant was fighting off an unwelcome megamerger offer from Pfizer three years
ago.
At the time, AZ CEO
Pascal Soriot estimated that a combination of anifrolumab and another
now-dropped candidate called sifalimumab could achieve $1 billion in annual
revenue in SLE.
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