BRIEF — Amryt allowed to add infants to epidermolysis bullosa trial

Rare diseases company Amryt Pharma has announced an update on its Phase III EASE trial for AP101 as a potential treatment for epidermolysis bullosa (EB).

Following an assessment by the trial’s Independent Data Monitoring Committee (IDMC), the company can now enrol infants and children with EB between the ages of 21 days to 4 years of age in to the trial.

The IDMC’s analysis was conducted using pharmacokinetic data received from patients already enrolled in the trial. This follows the announcement of the unblinded interim efficacy analysis in January.

Amryt will begin the recruitment process for infants and children into EASE immediately. The trial is the largest ever global Phase III study conducted in patients with EB and top-line data is expected in the second half of this year.