Clinical Trials Arena

Sanofi and Regeneron’s Dupixent scores second win in Phase III COPD trial

Companies plan to submit the supplemental data on Dupixent to the US Food and Drug Administration (FDA) by the end of 2023.

Sanofi and Regeneron have reported positive interim data from the Phase III NOTUS trial with Dupixent (dupilumab) showing a 34% reduction in exacerbations in chronic obstructive pulmonary disease (COPD) patients.

The NOTUS trial (NCT04456673) data confirms the results from the previous Phase III BOREAS trial (NCT03930732). Sanofi and Regeneron added that in light of the “overwhelming positive efficacy of the primary endpoint”, the interim analysis will be considered the primary analysis of the trial, as per a 27 November press release.

The companies also plan to submit data from NOTUS and BOREAS trials to the FDA by the end of 2023.

Earlier this year, Dupixent was granted breakthrough therapy designation as an add-on maintenance treatment in adult patients with uncontrolled COPD associated with a history of exacerbations and an eosinophilic phenotype by the FDA.

Dupixent is an interleukin-4 receptor alpha antagonist monoclonal antibody. The drug is jointly developed by Regeneron and Sanofi. The drug has been approved for multiple indications including atopic dermatitis, asthma and eosinophilic oesophagitis.

Dupixent generated €2.85bn ($3.1bn) in global sales in Q3 2023, as per Sanofi’s Q3 financial report. The drug sales are expected to increase, with the drug forecasted to generate $19.8bn in global sales in 2029, as per GlobalData analysis.

GlobalData is the parent company of Clinical Trials Arena.

Phase III NOTUS trial data

The randomised, placebo-controlled Phase III NOTUS trial enrolled 935 adult patients with moderate-to-severe COPD with type 2 inflammation who were either current or former smokers. The trial met its primary endpoint with a 34% reduction in moderate or severe acute COPD exacerbations over 52 weeks.

At 12 weeks, the lung function improved by 139ml in the treatment group compared to 57ml in the placebo group. This lung improvement was sustained over 52 weeks, with 115ml and 54ml improvement in lung function in the treatment and placebo groups, respectively.

The overall adverse event rates were comparable at 67% and 66% for the Dupixent and placebo groups, respectively. Commonly observed adverse effects seen in the trial were Covid-19, nasopharyngitis and headache. However, 2.6% of adverse events lead to death in the Dupixent group compared to 1.5% in the placebo group.

The results were comparable to the published data from the BOREAS trial. In the Phase III trial, there was a 30% reduction in moderate or severe acute COPD exacerbations over 52 weeks.

Sanofi and Regeneron are also developing another COPD treatment, itepekimab, an IL-33 inhibiting monoclonal antibody. Itepekimab is currently being evaluated in a Phase III trial (NCT04751487) in patients with moderate to severe COPD with data expected in 2025.