AC-203 clinical trial enrollment starts for EBS patients
Patients with EBS-related wounds sought in U.S., Europe, Asia, Australia
A Phase 2/3 clinical trial testing AC-203 (diacerein 1% ointment) in people with epidermolysis bullosa simplex (EBS) is recruiting participants.
The trial, EBShield (NCT06073132), seeks to enroll approximately 80 people ages 6 months and older with localized, severe, or intermediate EBS. To be eligible for participation, patients must have EBS-related wounds on at least 3% of their total body surface area, not counting the palms of the hands or soles of the feet. Enrollment is ongoing at more than 30 locations across the U.S., Europe, Asia, and Australia.
Participants in EBShield will be randomly assigned to treat their wounds daily with AC-203, applied to the skin as an ointment, or with a placebo ointment, for eight weeks.
Clinicians will rate the severity of patients’ wounds on a five-point scale from 0 (no wound) to 4 (severe wound). The study’s main goal is to see if AC-203 is better than the placebo at achieving treatment success, as defined by a score of 0 or 1 with at least a 2-point reduction relative to starting scores. The treatment’s effects on other measures, including pain, itching, and life quality, will also be assessed.
Clinical trial enrollment may lead to extension study
Participants who complete the eight-week placebo-controlled part of the trial can opt to enter an open-label extension study in which all will be treated with AC-203 and monitored for an additional period.
The trial is sponsored by TWi Biotechnology, which is developing AC-203 in partnership with Castle Creek Biosciences. An earlier Phase 2 trial (NCT03468322) sponsored by TWi tested AC-203 in nine people with EBS and other types of epidermolysis bullosa, with results showing that areas treated with AC-203 tended to have fewer blisters than areas given a placebo treatment.
A separate Phase 2 trial (NCT03154333) sponsored by Castle Creek tested AC-203 against a placebo in 54 people with EBS, with the goal of testing whether AC-203 was better than the placebo at reducing the area of wounds by at least 60%. The trial was terminated early after data showed it was unlikely to meet this goal.
AC-203Â is an ointment containing an anti-inflammatory compound called diacerein. EBS is marked by chronic wounds and blisters that don’t heal well, and chronic inflammation is thought to play a role in the formation and persistence of these wounds. By easing inflammation, AC-203 aims to help promote wound healing.
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