Sanofi, Regeneron’s IL-33 Drug Fails One of Two COPD Studies, Casting Doubt on FDA Approval Timeline

Sanofi and Regeneron's experimental IL-33-targeting drug, itepekimab, produced mixed results in two Phase 3 trials (AERIFY-1 and AERIFY-2) for chronic obstructive pulmonary disease (COPD)235.

In AERIFY-1, itepekimab achieved a statistically significant reduction in moderate or severe COPD exacerbations (27% reduction for two-week dosing, 21% for four-week dosing)24.

AERIFY-2 failed to demonstrate meaningful benefit, showing only a 2% reduction in exacerbations with two-week dosing and a 12% reduction with four-week dosing compared to placebo2.

Both trials enrolled over 2,000 former smokers with moderate-to-severe COPD, testing dosing every two or four weeks for 52 weeks2.

Sanofi attributed the underwhelming results partly to lower-than-expected exacerbation rates, potentially influenced by the COVID-19 pandemic affecting study power2.

The mixed results have thrown Sanofi’s timeline for an FDA approval submission into doubt, and shares of both companies dropped following the news234.

Itepekimab did not achieve statistically significant improvements across all primary endpoints, and Sanofi and Regeneron are reviewing data to determine next steps5.

Sources:

2. https://www.fiercebiotech.com/biotech/sanofi-regenerons-il-33-drug-fails-1-2-copd-studies-derailing-approval-plans

3. https://www.biopharmadive.com/news/regeneron-sanofi-itepekimab-copd-mixed-trial-results/749393/

4. https://endpts.com/sanofi-regeneron-report-underwhelming-data-for-il-33-antibody-itepekimab-shares-drop/

5. https://www.geneonline.com/sanofi-and-regeneron-report-mixed-phase-3-results-for-copd-drug-targeting-il-33-pathway/