Sanofi and Regeneron Pharmaceuticals have announced positive results from a second phase 3 trial, showing Dupixent (dupilumab) – when administered in 300mg doses weekly – significantly improved the signs and symptoms of eosinophilic oesophagitis (EoE) at 24 weeks, when compared to placebo in patients aged 12 years and above.
The data was presented at the 2022 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting and showed that patients treated with 300mg of Dupixent on a weekly basis experienced changes by week 24 compared to placebo, including a reduction of 64% in disease symptoms from baseline, compared to 41% for those who received placebo.
Additionally, the trial found that significantly more patients treated with Dupixent every two weeks, reduced their oesophageal eosinophilic count to the normal range compared to placebo. Despite this, there was not a significant improvement in dysphagia symptoms.
Detailed results on the every two week dosing will be presented at an upcoming congress.
EoE is a chronic, progressive type 2 inflammatory disease which damages the oesophagus and stops it from functioning normally. Swallowing the smallest amount of food or taking a sip of water can be a painful, increasing the risk of choking for patients with EoE.
The condition can also cause narrowing of the oesophagus, meaning physical expansion of the oesophagus may be needed which can often be painful for the patient. A feeding tube is the only option in severe cases of EoE, in order to ensure substantial caloric intake and weight gain.
In the US, there are approximately 160,000 patients living with EoE who are currently treated. Out of this amount, approximately 48,000 patients have failed multiple treatments.
Evan Dellon, Professor of gastroenterology and hepatology at the University of North Carolina School of Medicine and co-principal investigator of the trial, said: “Currently, there are no FDA-approved treatment options that address the underlying drivers of this disease. The data from this trial showed dupilumab taken weekly not only improved patients’ ability to swallow, but also reduced markers of type 2 inflammation in the oesophagus, indicating its potential to address a major underlying cause of eosinophilic oesophagitis.”
Results from the second phase 3 trial enrolled 80 patients in the Dupixent group and 79 patients in the placebo group, were announced in October 2021 and confirm results from the first phase 3 trial.
Data from the latest clinical trial programme have been submitted to the US Food and Drug Administration (FDA). The programme is ongoing, with patients involved from the first and second trials continuing into a 28-week extension trial, with results from the trial available later in 2022.