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Sanofi (NASDAQ:SNY) and Regeneron Pharmaceuticals’ (NASDAQ: REGION) Dupixent met the primary endpoint and all key secondary endpoints of a Phase 3 trial to treat adult current or former smokers with chronic obstructive pulmonary disease (COPD).
French pharmaceutical giant said Dupixent (dupilumab) showed the potential to become the first biologic to treat COPD by showing a significant reduction in exacerbations in the trial.
The late-stage study, called BOREAS, enrolled 939 adults, current or former smokers, 40 to 80 years of age with moderate to severe COPD and evidence of type 2 inflammation. Patients received Dupixent (n=468) or placebo. (n=471), in addition to maximum standard inhaled therapy (triple therapy). BOREAS is one of two trials in the Dupixent EPOC programme.
Patients treated with Dupixent experienced a 30% reduction in moderate to severe acute exacerbations of COPD over 52 weeks, which was the primary endpoint of the trial.
Sanofi said that Dupixent is the first and only biologic to demonstrate a clinically and statistically significant reduction in exacerbations compared to placebo.
In addition, the company said that Dupixent is the first and only biologic to show rapid and significant improvement in lung function.
Patients receiving Dupixent showed improved lung function from baseline by 160 mL at 12 weeks compared to 77 mL for placebo, and the benefit compared to placebo was maintained through week 52, both of which were key secondary endpoints. of the study according to the company.
Dupixent also showed improvements in quality of life and respiratory symptoms of COPD, according to the company.
“We took a bold approach with our direct-to-Phase 3 program, shaving years off standard clinical development timelines. We are excited to share these unprecedented and paradigm-shifting clinical results, which may give new hope to patients, caregivers and doctors. said Dietmar Berger, Sanofi’s acting director of global R&D and chief medical officer.
The company said the security was generally consistent with Dupixent’s known security profile. The overall adverse event (AE) rates were 77% for Dupixent and 76% for placebo.
The companies plan to share the results with the regulatory authorities.
COPD is a respiratory disease that damages the lungs and causes a progressive decline in lung function. Smoking is a key risk factor for COPD, but even people who quit smoking can develop the disease, according to the company.
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