Sanofi, Regeneron shares nosedive after mixed Itepekimab results
Sanofi’s U.S.-listed shares plunged more than 6% in premarket trading by 08:03 GMT, while Regeneron fell over 8%.
In one study involving former smokers with uncontrolled chronic obstructive pulmonary disease, the drug achieved its primary goal, showing a 27% reduction in moderate or severe exacerbations over 52 weeks compared to placebo.
However, the second late-stage trial did not meet its primary endpoint, though the companies noted signs of benefit earlier in the study period.
Itepekimab was generally well tolerated across both trials, Sanofi said in a release.
“While we are encouraged by the results of AERIFY-1, the results of both studies merit further exploration to have a full understanding of the data and the role that IL33 plays in this complex disease,” said Houman Ashrafian, Executive Vice President and Head of Research and Development at Sanofi.
“Certain people with COPD are in desperate need of new treatment options, especially those who continue to experience exacerbations despite being on maximal therapy, and we remain committed to discussing these data with regulatory agencies to evaluate our path forward.”
The French drugmaker said it is reviewing the findings with Regeneron and plans to consult with regulatory agencies to determine potential next steps.
Itepekimab is an experimental monoclonal antibody targeting interleukin-33 (IL-33), a cytokine believed to play a role in airway inflammation.
It is being developed by Sanofi and Regeneron as a treatment for COPD, particularly in patients who remain symptomatic despite standard therapies. The drug aims to reduce disease exacerbations by modulating inflammatory pathways linked to COPD progression.
