Dupixent® is the first biologic to demonstrate significant improvement in lung function compared to placebo, a pivotal Phase III trial has shown.
Key data from the BOREAS Phase III trial, the first out of two Phase III trials in the Dupixent® (dupilumab) development programme, has shown that of 939 adult patients, 30 percent experienced reduction in moderate or severe acute chronic obstructive pulmonary disease (COPD) exacerbations over 52 weeks.
The fully human monoclonal antibody is the first and only biologic to demonstrate significant improvements in lung function. This improvement showed 160mL in forced expiratory volume (FEV)1 compared to placebo (77 mL in FEV1) over 12 weeks. The benefit versus placebo was sustained through week 52.
Dupixent demonstrated ability to decrease type 2 inflammation in Phase III trials, establishing that IL-4 and IL-13 are key and central drivers. Over 600,000 patients are being treated for a variety of indications with Dupixent globally.
In Regeneron Pharmaceuticals and Sanofi’s pivotal Phase III trial, Dupixent was delivered in adults on maximal standard-of-care inhaled therapy (triple therapy) with uncontrolled COPD and evidence of type 2 inflammation.
COPD is a life-threatening respiratory disease that damages the lungs and causes progressive lung function decline. No new treatment approaches have been approved in over a decade, Sanofi stated.
Dupixent – a promising biologic
Dr George D Yancopoulos, PhD, President and Chief Scientific Officer at Regeneron, and a principal inventor of Dupixent shared: “In this landmark Phase III trial, patients with uncontrolled COPD achieved clinical outcomes with Dupixent at a magnitude never before seen with a biologic. These results also validate the role type 2 inflammation plays in driving COPD in these patients.”
patients with uncontrolled COPD achieved clinical outcomes with Dupixent at a magnitude never before seen with a biologic.”
The safety results were generally consistent with the known safety profile of Dupixent in its approved indications.
Detailed efficacy and safety results from the clinical trial will be presented in a future scientific forum. The second, replicate Phase III trial of Dupixent in COPD (NOTUS) is ongoing with data expected in 2024.
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