Sanofi-Regeneron find narrower population of former smokers for COPD drug after mid-stage trial fails overall goal

Lung Fibrosis
Previous COPD research and clinical evidence has discovered that some drugs work better in active versus former smokers. (Getty Images)

Sanofi and Regeneron began their collaboration in in chronic obstructive pulmonary disorder with a goal of targeting all patients, but now the data is pointing them towards former smokers.

A phase 2a study, published in The Lancet Wednesday, showed that the companies’ monoclonal antibody itepekimab lowered acute COPD exacerbations in former smokers. The study overall did not meet its goal, but the data did reveal some subgroups and different types of inflammation that could benefit from treatment.

“I've been practicing for 20 years and most of the drugs developed are still just different versions of the same inhalers that we've been using,” said Naimish Patel, Sanofi’s Therapeutic Area Head, Immunology and Inflammation. There remains a significant unmet need for patients, he noted.

Sanofi's latest results are helping it whittle down the right group of patients who could benefit from itepekimab. The company is working with Regeneron on the therapy, which originally developed it in-house.

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Sanofi and Regeneron already have a COPD trial with Dupixent, a blockbuster drug that is approved for atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyps. The French pharma's focus in COPD is on type 2 inflammation patients. Itepekimab, on the other hand, is being examined through an “all-comers” approach, according to Patel.

​  Naimish Patel
Naimish Patel (Sanofi)

Former smokers make up about 70% to 75% of the COPD population, which means itepekimab could have a big market. Dupixent, on the other hand, could pick up the rest of the group should the drug ultimately be approved for both populations.

“We'll probably have covered somewhere in the ballpark of 80 to 90% of COPD patients,” Patel said. “Our approach is using different compounds, different subtypes to try to eventually cover most all COPD patients who have this very high burden of disease and very high unmet need.”

Because of the variation in how COPD presents in patients, Patel said Sanofi started with the wider population for itepekimab. 

“There's a lot of difference between that big umbrella of COPD and it's probably not a disease that you can have a one size fits all therapy,” Patel said. COPD is typically treated with inhaled steroids or bronchodilators, which he describes as those “one size fits all” therapies.

Sanofi and Regeneron ultimately wanted to see a reduction in exacerbations in the entire study population, but the data showed only a 19% reduction, or a “trend” toward a benefit. But patients in the former smokers subgroup saw a 42% reduction in exacerbations. These results were highly statistically significant, according to Patel. Lung function was also improved in this group.

“42% reduction is huge. It's something that hasn't been really seen with any other treatment. Especially for this sick population,” Patel said.

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Previous COPD research and clinical evidence has discovered that some drugs work better in active versus former smokers. While the connection is not well understood, Patel said this suggests that there are different types of inflammation going on in each group of patients.

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.

Sanofi and Regeneron previously had hopes for a combination of itepekimab and Dupixent in asthma but ultimately halted development of that indication in February.