Sanofi and Regeneron have reported that the Phase III AERIFY-1 trial of the fully human monoclonal antibody itepekimab in former smokers who have inadequately controlled chronic obstructive pulmonary disease (COPD), met the primary goal.
Former smokers are said to be those who remain unsmoked for a minimum of six months.
Go deeper with GlobalData
The trial, which included 1,127 subjects, has achieved the primary endpoint, with a significant decrease of 27% in moderate or severe acute exacerbations against placebo at week 52.
Other Phase III study, AERIFY-2 in 953 subjects, however, did not meet the same primary goal, despite showing an earlier benefit in the trial.
These randomised, double-blind, placebo-controlled trials assessed the safety and efficacy of the antibody in adult patients aged 40-85 years.
Subjects in both studies were given itepekimab every two or four weeks, or a placebo, in addition to standard-of-care therapy.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataThe companies noted that the total number of exacerbations in both trials was lower than expected, potentially due to enrolment during the Covid pandemic globally, which may have influenced the overall exacerbation rates.
The safety profile of the antibody was found to be consistent across dosing regimens.
Sanofi Research and Development head and executive vice-president Houman Ashrafian said: “While we are encouraged by the results of AERIFY-1, the results of both studies merit further exploration to have a full understanding of the data and the role that interleukin-33 (IL33) plays in this complex disease.”
In AERIFY-1, the overall rates of adverse events (AEs) were observed as 67% and 68% for itepekimab every two weeks and every four weeks, respectively, against 68% for placebo.
AERIFY-2 showed similar results, with overall rates of AEs at 64% and 71% for the respective itepekimab dosing schedules, against 64% for placebo.
The rate of serious infections was slightly lower in the antibody arms than in the placebo in AERIFY-1, but similar in AERIFY-2.
Deaths due to AEs were low across both trials, with anti-drug antibodies being uncommon and without any apparent impact on drug levels.
In 2023, the companies reported positive interim data from the Phase III NOTUS trial with Dupixent (dupilumab), showing a 34% decrease in exacerbations in COPD patients.
