Endpoints met in phase 2a trial of AB-101a for pediatric atopic dermatitis

Key takeaways:

• AB-101a improved mild to moderate atopic dermatitis in pediatric patients as young as 2 years old.
• All primary and secondary efficacy endpoints were met in the phase 2a trial.

Alphyn Biologics reported positive results for topical AB-101a in a phase 2a clinical trial in pediatric patients with mild to moderate atopic dermatitis.

“We are extremely pleased with the pediatric results,” Neal Koller, CEO of Alphyn, said in a press release. “The improvements these children experienced in the severity of disease and symptoms are particularly remarkable. AD can be a lifelong chronic disease, and options are needed for long-term continuous use.”

The randomized double-blind study evaluating AB-101a, a novel topical candidate developed to treat immune and bacterial components of AD, met all primary and secondary efficacy endpoints while maintaining a positive safety profile.

Twenty-seven participants in the study were between the ages of 2 and 17 years old. After 4 weeks of treatment, approximately 52% of those who received AB-101a achieved IGA score improvement compared with 0% of those who received vehicle control.

Key secondary endpoints were also met. Approximately 35% of those who received AB-101a- achieved EASI 75 compared with 0% who received vehicle. Additionally, 32% had an improvement in body surface area, and 62% had an itch score improvement of at least 4.

No serious adverse events were reported. Adverse events for AB-101a included mild transient stinging in three participants.

The company plans to initiate a phase 2b trial in the U.S., Europe, Canada and Australia.

Reference:

• Spelman L, et al. Phase 2 trial of novel topical drug AB-101a for treatment of mild to moderate atopic dermatitis in children and adults. Presented at: European Society for Pediatric Dermatology congress; May 4-6, 2023; Málaga, Spain. https://alphynbiologics.com/news/poster-presentation-phase-2a-trial-of-ab-101a-for-mild-to-moderate-atopic-dermatitis-pediatric-patients/.