Sanofi and Regeneron have shared positive results from a late-stage trial of Dupixent (dupilumab) in chronic obstructive pulmonary disease (COPD).
The phase 3 NOTUS trial has been evaluating the investigational use of Dupixent compared to placebo in adults currently on maximal standard-of-care inhaled therapy with uncontrolled COPD and evidence of type 2 inflammation.
The trial met its primary endpoint, with Dupixent shown to reduce moderate or severe acute COPD exacerbations by 34% compared to placebo.
Results from the interim analysis also demonstrated that Dupixent improved lung function from baseline by 139ml at 12 weeks compared to 57ml for placebo, with this benefit sustained at week 52.
COPD is a chronic respiratory disease that causes lung function to progressively decline. Approximately 300,000 people in the US live with uncontrolled cases of the condition and evidence of type 2 inflammation.
The positive readout from NOTUS builds on the previous results from the phase 3 BOREAS trial, in which patients receiving Dupixent experienced a 30% reduction in moderate or severe acute COPD exacerbations over 52 weeks compared to placebo.
The study also showed a 160ml improvement in lung function from baseline at 12 weeks in the Dupixent-treated cohort versus 77ml in the control group, with the benefit versus placebo sustained through week 52.
Dupixent has already received regulatory approvals for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic oesophagitis and prurigo nodularis.
Earlier this year, the US Food and Drug Administration (FDA) granted Breakthrough Therapy designation for Dupixent as an add-on maintenance treatment in adult patients with uncontrolled COPD associated with a history of exacerbations and an eosinophilic phenotype based on the positive results from BOREAS.
Sanofi and Regeneron outlined that they plan to submit the data from NOTUS, along with positive results from BOREAS, to the FDA by the end of the year.
Naimish Patel, head of global development, immunology and inflammation at Sanofi, said: “This is the first and only time an investigational biologic in COPD has shown a significant and clinically meaningful reduction in exacerbations in two phase 3 trials and we are pleased that we can potentially deliver Dupixent faster to patients in need where no new advancements have been identified in over a decade.”