| PARIS/NEW YORK, July 9
PARIS/NEW YORK, July 9 An experimental drug from
Sanofi and Regeneron Pharmaceuticals Inc
significantly reduced skin lesions and itching in adult patients
with atopic dermatitis, a chronic form of eczema that is poorly
controlled by standard drugs, the companies said on Wednesday.
The findings were seen in a Phase IIb, or mid-stage, trial
of the injectable drug dupilumab, which is also being tested by
the drugmakers against two other allergic conditions: asthma and
Dupilumab was named "clinical advance of the year" in 2013
by industry publication Scrip Intelligence, and some analysts
expect it to capture annual sales up to $2 billion if approved.
Atopic dermatitis causes patches of dry, red and 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.
Currently, patients get limited relief from topical steroid
creams and oral steroid medicines that are not approved in the
United States for the condition.
Dupilumab works through a new approach, by blocking two
proteins linked to inflammation, interleukin-4 (IL-4) and
The 16-week Phase IIb clinical trial involved 380 adults
with moderate to severe atopic dermatitis, and about half their
skin was affected by the disease. All doses of dupilumab met the
study's main goal, showing greater improvement of eczema
symptoms compared to placebo.
Improvement rates ranged from 74 percent for patients on the
highest dose (300 mg weekly) to 45 percent in those with the
weakest dose (100 mg monthly), as judged by a standard index
that evaluates area and severity of eczema. That compared with
an 18 percent improvement in patients given a placebo.
"It's really the itch associated with atopic dermatitis that
can affect your quality of life, your employment and ability to
function and to go to school and to sleep," George Yancopoulos,
Regeneron's research chief, said in an interview.
Dupilumab, if approved, would likely be the first drug to
directly target proteins that cause the disease, Yancopoulos
In separate Phase IIa trial results published last year,
dupilumab slashed asthma episodes by 87 percent, making it a
potential game changer for patients with moderate to severe
The most common side effects of the drug include
nasopharyngitis (common cold) and headache.
Sanofi and Regeneron expect to begin late-stage trials of
dupilumab in atopic dermatitis later this year.
The New England Journal of Medicine on Wednesday published
favorable data from earlier studies of dupilumab in atopic
Dr. Lisa Beck, a professor of dermatology at Rochester
Medical Center who helped conduct those trials, said about 3.4
million U.S. adults have moderate to severe atopic dermatitis.
"We will get a surge of eczema patients seeking treatment
with this drug" if it is approved, she predicted.
(Reporting by Natalie Huet and Ransdell Pierson; Editing by