The ACESO trial is a randomised, placebo-controlled, double-blind Phase II study in which ESO-101 was compared with placebo in 43 patients in five countries. The ACESO study met its primary endpoint with a statistically significant reduction in peak eosinophil counts on histological evaluation of oesophageal biopsies, confirming superiority over placebo with a p-value <0.05. Patients receiving ESO-101 experienced a 50% reduction in eosinophil counts, while patients receiving placebo experienced no change from baseline, demonstrating a significant difference between the efficacy of active treatment and placebo control.
The study also showed that ESO-101 has a very favourable safety and tolerability profile. 7.1% (n=2) of patients treated with ESO-101 and 26.7% (n=4) in the placebo group reported mild to moderate adverse events related to the investigational product.
These results mark an important milestone for EsoCap and represent a substantial value inflection point.