Dupixent Clears Phase III in Bid to Become First Biologic for COPD
A technician holds up an X-ray of lungs/Courtesy Shutterstock
Sanofi and Regeneron’s Dupixent (dupilumab) met its primary and all secondary endpoints in the Phase III BOREAS trial, significantly reducing moderate or severe episodes of exacerbations in chronic obstructive pulmonary disease (COPD), the partners announced Thursday.
Dupixent is the first biologic agent to display statistically significant and clinically meaningful improvements in COPD exacerbations and lung function in this indication, according to the announcement.
Compared with placebo, Dupixent led to a 30% drop in moderate or severe acute COPD exacerbations over 52 weeks of treatment. Dupixent was also better than placebo at improving lung function. Patients in the respective groups saw a 160-mL and 77-mL increase in lung function at 12 weeks. This treatment effect proved to be significant in Dupixent’s favor and persisted through 52 weeks.
These findings underscore the therapeutic potential of Dupixent in COPD “at a magnitude never before seen with a biologic,” George Yancopoulos, M.D., Ph.D., president and chief scientific officer, Regeneron, said in a statement.
BOREAS, a randomized, double-blinded and placebo-controlled trial, enrolled 939 adult COPD patients who were current or former smokers and who had moderate-to-severe disease. All participants also showed evidence of type 2 inflammation.
Over the 52-week trial period, Dupixent or placebo was added to each patient’s current treatment regimen, which included inhaled corticosteroids, long-acting beta agonists and long-acting muscarinic antagonists.
Dupixent’s adverse event profile was consistent with that of its known side effects in approved indications. Adverse events arose in 77% of patients treated with Dupixent and in 76% of placebo comparators. Common side effects included headache, diarrhea and back pain.
Toxicities leading to death were also balanced between the Dupixent and placebo groups.
The partners will present detailed analyses of BOREAS at a future scientific forum and plan to engage regulatory authorities with these data, Yancopoulos said.
Dupixent is a monoclonal antibody designed to disable the IL-4 and IL-13 signaling pathways without suppressing the immune system at large. This mechanism of action has resulted in its strong clinical performance in diseases driven by type 2 inflammation.
The biologic agent is being developed jointly and equally by both Regeneron and Sanofi as part of a sweeping 2007 agreement to advance therapeutic antibodies. Dupixent has since picked up several FDA approvals, including for eczema, asthma and atopic dermatitis.
In COPD, the partners are running two pivotal programs, of which BOREAS is the first. The second, a Phase III study dubbed NOTUS, is currently ongoing, with data expected in 2024.
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