New Drug is ‘Game-Changer’ for AsthmaticsTuesday, 21 May 2013
A new type of
asthma drug meant to
attack the underlying causes of the respiratory disease slashed
episodes by 87 percent in a mid-stage trial, making it a potential
game changer for patients with moderate to severe disease,
researchers said on Tuesday.
"Overall, these are the most exciting data we've seen in asthma in
20 years," said Dr.
Sally Wenzel, lead
investigator for the 104-patient study of dupilumab, an injectable
treatment being developed by
Regeneron Pharmaceuticals Inc
and French drugmaker
Sanofi.
The drug also met all its secondary goals, such as improving
symptoms and lung function and reducing the need for standard drugs
called beta agonists
.
Although far larger trials will be needed to confirm findings from
the "proof of concept" study, researchers expressed optimism. They
noted that dupilumab has also shown the ability to tame
atopic
dermatitis, or severe eczema, an allergic condition
that is not well controlled by current treatments.
Results of the 12-week
asthma study are being
presented on Tuesday at the annual scientific meeting of the
American Thoracic Society in Philadelphia.
The medicine, if approved, could hold promise for patients with
moderate to severe persistent asthma that is not well controlled by
standard drugs.
"We have been treating asthma with sort of Band-Aid therapies that
didn't get at the underlying causes,"
Wenzel said in an
interview, adding that dupilumab could be an important step in going
to the root of the problem.
The drug works by simultaneously blocking proteins that have been
linked to inflammation, interleukin-4 (IL-4) and interleukin-13
(IL-13).
HITS ELUSIVE TARGETS
Wenzel, director of the Asthma Institute at the University of
Pittsburgh, said other drugmakers have tested medicines that block
one or both of the proteins, but without success.
The trial recruited patients with high levels of eosinophils, a
biomarker that shows immune system cells called type 2 helper T
cells (Th2 cells) associated with allergy and asthma have been
activated.
Such patients were deemed likely to benefit from treatment.
All patients initially stayed on their standard asthma treatments,
meaning medium-to-high doses of inhaled glucocorticoids, as well as
long-acting beta agonists. But patients gradually tapered off on
those drugs and were no longer taking either of them after 9 weeks.
Throughout the Phase IIa trial, half the patients also received
weekly injections of dupilumab, while half received placebo
injections.
After the ninth week, about 25 percent of those on placebos had
experienced exacerbations, a catch-all term that included the need
to take a beta agonist, a decrease in lung function, the need for an
oral or inhaled corticosteroid, or if the patient went to the
hospital or emergency room for worsening asthma.
"By end of the trial, after 12 weeks, 44 percent of those in the
placebo group had exacerbations, compared with 5 percent of those on
dupilumab," Wenzel said.
That represented an overall 87 percent reduction in exacerbations,
which Wenzel said was highly statistically significant.
Wenzel said dupilumab was well tolerated, with side effects similar
to placebo. But she cautioned that longer trials are needed to fully
assess the drug.
Regeneron and Sanofi said standard drugs are unable to
control asthma well in 10 to 20 percent of patients. They estimate
that inflammation caused by Th2 cells - the type of inflammation
among patients they tested - plays a role in half of those moderate
to severe cases and affects as many as 2.5 million people in the
United States and up to 30 million worldwide.
Dupilumab has also shown strong hints of safety and effectiveness in
two early-stage trials that involved 67 patients with atopic
dermatitis. Larger studies are slated to begin later this year.
Atopic dermatitis is inherited and involves patches of highly itchy
skin on any part of the body. Patients, many of whom also have
asthma and hay fever, have compared the sensation to having unending
poison ivy.
"This asthma data and the data we already have in atopic dermatitis
really raises the possibility the scientific community has finally
hit upon the key pathway across all these allergic diseases," George
Yancopoulos, Regeneron's research chief, said in an interview.
Regeneron has become one of the world's biggest biotechnology
companies in the past 18 months, following the U.S. approval in late
2011 of its Eylea treatment, developed with Bayer AG. It is used to
treat the "wet" form of macular degeneration, the leading cause of
blindness in the elderly.
The company and partner Sanofi are also developing promising
treatments for cholesterol and rheumatoid arthritis.
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