- Sanofi/Regeneron's dupilumab is being developed to treat moderate-to-severe asthma in adults whose asthma is uncontrolled despite inhaled corticosteroid and long-acting beta agonist ICS/LABA treatment.
- The companies reported positive 2b results at the American Thoracic Society meeting. The study met its primary endpoint: improving lung function in patients with high blood eosinophil counts.
- This phase 2b study is one of two pivotal studies needed before Regeneron/Sanofi can file a biologics approval application (BLA) with the FDA. The candidate is also being tested in a variety of other conditions, including as a therapy for nasal polyps and a breakthrough treatment for atopic dermatitis.
The phase 2b study conducted by the two companies was a double-blind, placebo-controlled, 24-week study with a total of 776 adult patients with moderate-to-severe uncontrolled asthma. The study enrolled patients with high eosinophil counts (300 eosiniphilic cells/microliter or more) or low counts (<300). In both patient groups, dupilumab improved lung function and reduced airway inflammation, with statistically significant results.
During the JP Morgan Healthcare Conference this past January, BioPharma Dive spoke with Sanofi EVP Pascale Witz about the company's pipeline and launch hopefuls for 2015. Witz indicated that dupilumab was one of the most exciting candidates to watch. "Quite frankly, I think dupilumab is very exciting," said Witz. "It's one biological pathway that can express itself in different forms." The drug is an IL-4 and IL-13 antibody that may become the first-ever approved, safe, and long-acting treatment for atopic dermatitis; a therapy for nasal polyps; as well as an asthma indication. It has blockbuster potential written all over it.