Sanofi and Regeneron have begun collaborative research on chronic obstructive pulmonary disease with the goal of targeting all patients, but data are now targeting them to ex-smokers.
A phase 2a study presented at Lancet on Wednesday showed that the monoclonal antibodies itepekimab from both companies reduced the acute COPD exacerbations of former smokers. Although the study did not achieve that goal overall, the data revealed different types of inflammation than some subgroups that could benefit from treatment.
Naimish Patel, Head of Immunology and Inflammation Treatment at Sanofi, said: He said there remains a significant unmet need for patients.
Sanofi’s latest results have helped reduce the appropriate patient group that may benefit from itepekimab. The company is working with Regeneron on treatments originally developed in-house. Regeneron has another drug called dupilumab that is currently in Phase 3 trials for COPD.
Sanofi is already conducting a COPD trial with the blockbuster drug dupilumab in partnership with Regeneron It is approved for atopic dermatitis, asthma, and chronic sinusitis with nasal polyps. French pharmaceutical companies are focusing on COPD for patients with type 2 inflammation. On the other hand, according to Patel, itepequimab is being considered with an “everyone” approach.
Former smokers make up about 70% to 75% of the COPD population, which means that itepeki mab has the potential to have a large market. Dupilumab, on the other hand, may pick up the remaining members of the group if the drug is ultimately approved in both populations.
“Probably covers somewhere in the stadium of 80-90% of COPD patients,” Patel said. “Our approach uses different compounds and different subtypes to ultimately cover almost all COPD patients with this very high disease burden and very high unmet needs.”
Due to the variability in how COPD appears in patients, Patel said sanofi began with a wider population of itepekimab.
“There are many differences between large COPD umbrellas, and it’s probably not a disease to be able to fit all treatments in one size,” Patel said. COPD is usually treated with inhaled corticosteroids or bronchodilators. He explains that this is a “one size fits all” treatment.
Sanofi and Regeneron eventually wanted to see a decrease in the deterioration of the entire study population, but the data showed only a 19% decrease, a “trend” to profits. However, patients in the previous smoker subgroup had a 40% reduction in exacerbations. According to Patel, these results were statistically very significant. Lung function was also improved in this group.
“The 40% reduction is huge. This is something we didn’t really see with other treatments, especially for people with this disease,” Patel said.
Previous COPD studies and clinical evidence have found that some drugs work more effectively in active smokers than in ex-smokers. The relationship is not well understood, but Patel said this suggests that there are different types of inflammation occurring in each group of patients.
The study also included an active smoker’s arm to confirm that itepekimab was ineffective. Meanwhile, itepekimab has already transitioned to a previous phase 3 clinical trial in the smoker population.
Sanofi and Regenerone had previously expected the combination of itepekimab and dupilumab in asthma, but eventually stopped developing the indication in February.
https://www.fiercebiotech.com/biotech/sanofi-wants-to-capture-up-to-90-copd-patients-itepekimab-and-dupixent Sanofi-Regeneron found that the population of former smokers of COPD drugs has declined after mid-stage trials failed the overall goal