A multiple ascending dose, phase1b study to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of lesigercept, a long-acting IgE Trap -Fc fusion protein, in participants with atopy or allergic diseases.

In 30 seconds

This phase 1b randomized controlled trial evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of lesigercept in adults with atopy or allergic diseases. The study found that lesigercept led to a significant suppression of serum free IgE levels, with longer durations below 25 ng/mL compared to placebo (10-29 days vs 0 days).

Key findings

• Treatment-emergent adverse events occurred in 36.0% of lesigercept participants in Cohorts 1-4.
• Lesigercept exposure increased dose-dependently, with no serious adverse events reported.
• Serum free IgE levels were suppressed in all lesigercept groups.
• Median durations of serum free IgE below 25 ng/mL were longer for lesigercept than placebo.

Why it matters

Understanding the safety and efficacy of new treatments like lesigercept is crucial for managing patients with atopy and allergic diseases. Effective IgE suppression can lead to improved patient outcomes.