Sanofi, Regeneron gear up for new Dupixent filing after clearing second PhIII for eosinophilic esophagitis
This fall’s harvest is proving fruitful for Dupixent.
Days after touting a clean Phase III sweep in prurigo nodularis, Sanofi and Regeneron report that their blockbuster anti-inflammatory drug has passed another Phase III test with flying colors, paving the way for regulatory filings in 2022.
It’s the second trial where Dupixent has proven effective against eosinophilic esophagitis, meeting the co-primary endpoints by spurring significant improvements in both clinical and histologic disease measures.
A chronic immune system disease, eosinophilic esophagitis (or EoE) occurs when a type of white blood cells called eosinophils build up in the lining of the esophagus, injuring the tissue and causing difficulty — or worse, pain or danger — in swallowing.
“This trial gives insight into how terrible this disease can be, with more than a third of patients having previously required invasive endoscopic dilations that can temporarily reduce symptoms but carry the risk of rupturing the esophagus,” said George Yancopoulos, president and CSO of Regeneron.
Dupixent blocks both IL-4 and IL-13, which Regeneron has long posited are main drivers of allergic or type 2 inflammation.
The hypothesis has been borne out across five other diseases: asthma, nasal polyps, atopic dermatitis, chronic spontaneous urticaria and most recently prurigo nodularis.
In the latest EoE trial, 80 patients received Dupixent 300 mg weekly and 79 others got placebo. Those who were treated with Dupixent saw a 64% reduction in disease symptoms at week 24 from baseline compared to 41% for placebo (p=0.0008), and on a 0-84 scale capturing difficulty swallowing, they experienced a 23.78 point improvement from 38 compared to 13.86 from 36 (p<0.0001).
Perhaps more strikingly, 59% of the Dupixent group achieved histological disease remission versus just 6% in the placebo arm — nearly 10 times the difference.
Those results are in line with a positive readout from the first Phase III trial in EoE, released in May. The drug has been granted a breakthrough therapy designation from the FDA in this indication — indicating that the partners likely won’t have to wait long on the FDA.
Sanofi and Regeneron estimate that around 160,000 people in the US suffer from EoE who are currently being treated, and among them, approximately 48,000 have failed multiple treatments.
Investigators are continuing to study Dupixent in an extension trial.