Eli Lilly reports EBGLYSS Phase 3b dermatitis results

• Eli Lilly (NYSE:LLY) reported that EBGLYSS met the primary and secondary endpoints in a Phase 3b study evaluating hand-and-foot atopic dermatitis.
• At Week 16, 53% of EBGLYSS patients achieved clear or almost clear hands and feet compared with 27% for placebo.
• Lilly submitted the data to the FDA and plans regulatory submissions in select markets for a potential label update.

Eli Lilly (NYSE:LLY) reported Phase 3b ADtouch study results showing EBGLYSS monotherapy met its primary and secondary endpoints in adults and adolescents with hand-and-foot atopic dermatitis.

The study enrolled 221 participants and compared EBGLYSS treatment every two weeks with placebo over 16 weeks, with 53% of treated patients achieving clear or almost clear hands and feet compared with 27% receiving placebo.

Among patients with baseline symptom scores of at least four, a four-point improvement in itch was reported in 57% of EBGLYSS patients versus 19% for placebo, while pain improvement was reported in 59% versus 19%, respectively, and adverse events occurred in 41.8% versus 39.6%.

The study also found that among patients initially dissatisfied with hand clearance, 77% of EBGLYSS-treated patients reported being satisfied or very satisfied at Week 16 compared with 40% for placebo.

Eli Lilly submitted the ADtouch data to the U.S. Food and Drug Administration and stated that it plans additional submissions to select global regulators for a potential EBGLYSS label update.