Sanofi-Regeneron's COPD Drug Fails In Mid-Stage Trial, But Shows Potential Benefit In Subgroup of Former Smokers

Sanofi SA SNY and Regeneron Pharmaceuticals Inc REGN started their collaboration in chronic obstructive pulmonary disorder (COPD) to target all patients, and the data is pointing them towards former smokers.

What Happened: A phase 2a study, published in The Lancet, showed that the companies' itepekimab, a monoclonal antibody lowered acute COPD exacerbations in former smokers. 

Overall, the study did not meet its goal, but the data did reveal some subgroups and different types of inflammation that could potentially benefit from treatment.

Annualized rates of acute exacerbations of COPD were 1·61 in the placebo group and 1·30 in the itepekimab group (relative risk [RR] 0·81.

When the analysis was restricted to former smokers, treatment with itepekimab was associated with nominally significant reductions in acute exacerbations of COPD (RR 0·58). 

Why It Matters: Current smokers treated with itepekimab showed no treatment benefit versus placebo for exacerbations. 

Treatment-emergent adverse events (TEAEs) occurred in 135 (78%) patients in the itepekimab group and 136 (80%) in the placebo group. 

The most common TEAEs were nasopharyngitis (16% vs. 29%), bronchitis (10% vs. 8%), headache (8% vs. 13%), and upper respiratory tract infection (18% vs. 9%).

The study also includes an arm of active smokers to confirm the lack of effect from itepekimab. Meanwhile, itepekimab has already moved into phase 3 clinical trials in the former smoker population.

Price Action: REGN shares are up 0.99% at $589.49, and SNY stock is up 0.15% at $51.58 during the market session on the last check Thursday.

Photo by Gerd Altmann from Pixabay