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In a recent phase 2b study, patients with asthma reported reduced exacerbations and improved lung function after receiving dupilumab, an investigational therapy from Sanofi-Aventis and Regeneron Pharmaceuticals Inc.
In a recent phase 2b study, patients with asthma reported reduced exacerbations and improved lung function after receiving dupilumab, an investigational therapy from Sanofi-Aventis and Regeneron Pharmaceuticals Inc.
According to the companies, dupilumab blocks interleukin 4 and 13, which are 2 cytokines needed for the T helper cell type 2 immune response.
In the trial, 776 patients with moderate-to-severe uncontrolled asthma were randomized to receive 1 of 4 doses of dupilumab or placebo. Those who received the 3 highest doses of dupilumab and continued standard-of-care therapy experienced significant improvement in forced expiratory volume over 1 second (FEV1) at week 12, compared with those who did not receive the drug.
Some individuals had an adverse injection site reaction, while others experienced upper respiratory tract infection, headache, nasopharyngitis, and bronchitis.
“Patients with moderate-to-severe asthma have a high unmet medical need, often struggling with daily symptoms and recurring asthma attacks, despite the use of inhaled steroids, long-acting beta agonists, and rescue medications,” said George D. Yancopoulos, MD, PhD, chief scientific officer of Regeneron and president of Regeneron Laboratories, in a press release. “This trial is encouraging, given the positive results observed on the most clinically meaningful endpoints—FEV1, a key measure of lung function, and asthma exacerbations–were seen on top of ongoing background therapy.”
Both manufacturers now plan to move the drug into phase 3 clinical development.