Sanofi/Regeneron Dupixent shows efficacy in kids with esophagus inflammation in phase 3 trial
Sanofi (NASDAQ:SNY) and Regeneron Pharmaceuticals (NASDAQ:REGN) said their medicine Dupixent showed positive results in a phase 3 trial to treat children aged one to 11 years with active eosinophilic esophagitis (EoE).
EoE is a chronic and progressive inflammatory disease which damages the esophagus and can make it difficult to swallow.
Dupixent led to significant improvements in the main efficacy measure for higher (n=37) and lower (n=31) dose groups at 16 weeks in placebo-controlled study, Sanofi said in an Oct. 11 press release.
For those on Dupixent, 68% of children on higher dose and 58% of patients on lower dose achieved the main goal of significant histological disease remission, compared to 3% for placebo, the company added.
Sanofi noted that patients on the higher dose regimen also experienced significant improvements in abnormal endoscopic findings of their esophagus, with a reduction of 3.5 points for the drug, compared to an increase of 0.3 points for placebo.
Sanofi noted that though not statistically significant, symptomatically, higher dose Dupixent led to a numerical improvement in the proportion of days children experienced disease symptoms from baseline, compared to placebo.
In addition, the company said that Dupixent led to a 3.09 percentile increase in body weight for age percentile from baseline, compared to 0.29 for placebo.
For the 16-week, the overall rates of adverse events (AEs) were 79% (higher dose n=27/37, lower dose n=26/30) for Dupixent and 91% (n=31/34) for placebo.
AEs most commonly seen with Dupixent (≥5%) compared to placebo included COVID-19 (higher dose n=5/37, lower dose n=9/30, placebo n=0/34; all cases were mild or moderate and did not lead to study discontinuation); rash (higher dose n=3/37, lower dose n=3/30, placebo n=2/34); viral gastroenteritis (higher dose n=4/37, lower dose n=0/30, placebo n=1/34), among others, the company added.
Sanofi noted that safety results were generally consistent with the profile seen in children and adults aged 12 years and older with EoE.
In May, Dupixent was approved in the U.S. to treat children and adults aged 12 years and older with EoE.