Sanofi-Regeneron's trial drug may let smokers breathe easy

HQ Team

March 24, 2023: Smokers may benefit from Sanofi’s asthma drug after a phase III trial showed “significant improvements in lung function, quality of life” and uncontrolled chronic obstructive pulmonary disease respiratory symptoms.

It is the first drug to demonstrate a “clinically meaningful” reduction, of 30%, in exacerbations compared to the placebo and improve lung function, according to a company statement.

The group of lung diseases, or COPD, is the third leading cause of death worldwide, with no new treatment approaches approved in more than a decade.

Smoking is a key risk factor for developing pulmonary disease, but even individuals who quit smoking can still develop the disease. In the U.S. alone, approximately 300,000 people live with the uncontrolled disease with type II inflammation.

The life-threatening respiratory disease damages the lungs and causes a progressive decline in lung function.

Persistent cough

Symptoms include persistent cough and breathlessness that may impair the ability to perform routine daily activities and lead to anxiety, depression and sleep disturbances.

Acute exacerbations require systemic corticosteroid treatment or lead to hospitalization or even death.

The phase-three trial enrolled patients with moderate to severe disease and evidence of type 2 inflammation (blood eosinophils ≥300 cells/μL.)

“Change cannot come quick enough for people living with uncontrolled COPD, but, unfortunately, many investigational treatments have failed to demonstrate significant clinical outcomes leaving these vulnerable patients with limited treatment options, said Dietmar Berger, Head of Global R&D at Sanofi.

‘Shaving years off‘

“We took a bold approach with our direct-to-Phase 3 programs, shaving years off standard clinical development timelines.”

Dupixent met all the endpoints, including improvement in patient-reported health-related quality of life and reduction in the severity of respiratory symptoms of COPD, according to the statement.

In the phase III trial (the first of two Phase 3 trials), 939 adults who were current or former smokers aged 40 to 80 years were randomized to receive Dupixent or placebo, added to maximal standard-of-care inhaled therapy.

Overall rates of adverse events were 77% for Dupixent and 76% for the placebo.

“COPD is an urgent global health concern and a notoriously difficult-to-treat disease due to its heterogeneity, with no novel treatments approved in more than a decade,” said George D. Yancopoulos, President and Chief Scientific Officer at Regeneron, which co-developed the drug.

‘Biology of disease’

“These results also validate the role type 2 inflammation plays in driving COPD in these patients, advancing the scientific community’s understanding of the underlying biology of this disease. We look forward to discussing these exciting results with regulatory authorities.”

Detailed efficacy and safety results from the trial will be presented in a future scientific forum, according to the statement.