Sanofi, Regeneron boast PhIII win with Dupixent in COPD, clearing first bar for expansion

Dupixent, the blockbuster anti-inflammatory drug from Sanofi and Regeneron, has cleared a high-stakes Phase III study in chronic obstructive pulmonary disease, the companies announced Thursday morning.

If they hold up in a second, identical trial, the data pave the way for Dupixent to become the first biologic to treat patients whose COPD remains uncontrolled despite being on maximal standard-of-care inhaled therapy — the patient population studied in the pivotal program. The companies had spotlighted this as a key readout as they look to expand the Dupixent franchise and explore its full potential.

The BOREAS trial enrolled 939 adults with COPD between 40 and 80 years old who were current or former smokers. Half received Dupixent and the other half received placebo, both on top of maximal standard of care.

In the Dupixent group, Sanofi and Regeneron tracked a 30% reduction in moderate or severe acute COPD exacerbations over a year (p=0.0005), hitting the primary endpoint.

Dietmar Berger

Dietmar Berger, Sanofi’s chief medical officer and interim head of global R&D, noted that people living with uncontrolled COPD face limited options and many investigational treatments have disappointed in clinical trials.

Other than inhalers, currently, patients can take tablets to help make breathing easier. Often, they are either bronchodilators that widen the airway in the lung or drugs that suppress inflammation. Then there are treatments like Daliresp, approved to prevent exacerbations.

But ultimately most of the current treatments only offer symptom relief rather than addressing the underlying causes of the disease, developers of biologics argue. Notably, AstraZeneca’s Fasenra and GSK’s Nucala — approved for asthma — both failed to prove their use in COPD.

“We took a bold approach with our direct to Phase 3 program, shaving years off standard clinical development timelines,” Berger said in a statement.

On top of the reduction in exacerbations, Dupixent was also shown to improve lung function from baseline by 160 mL at 12 weeks, compared to 77 mL for placebo (p<0.0001), and the benefit was sustained through week 52 (p=0.0003).

To enroll in the trial, patients were screened for the presence of eosinophils, a type of disease-fighting white blood cells and evidence for type 2 inflammation — which the companies say its IL-4/IL-13 inhibitor is particularly suited to treat.

Sanofi and Regeneron also excluded patients with asthma from the trial, preempting questions about the drivers of efficacy. GSK faced those questions with Nucala, which passed one trial, failed another and was ultimately rejected by the FDA.

biologics
medical
fda
clinical trials