AB-101a rapidly reduces itch in patients aged as young as 2 years with atopic dermatitis
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Key takeaways:
- 53.3% of pediatric patients treated with AB-101a achieved a 1-point decrease in IGA vs. 0% of those treated with vehicle.
- This outcome was also seen in 60% of adults using the topical vs. 37.5% using vehicle.
Alphyn Biologics announced new data from its phase 2a clinical trial evaluating topical AB-101a for the treatment of mild to moderate atopic dermatitis in patients aged as young as 2 years, according to a company release.
Earlier this year, Alphyn Biologics announced that this phase 2a trial met all primary and secondary efficacy endpoints, as Healio previously reported.
Now, new data from the trial has been released in a poster at the 25th World Congress of Dermatology in Singapore showing that AB-101a, a hydrogel topical, rapidly reduces itch during AD flares.
“Research shows that the bacteria microbiome on the AD skin causes flare-ups, which also sometimes worsen to cause infection,” Neal Koller, CEO of Alphyn, told Healio. “What Alphyn uniquely aims to do with AB-101a is to manage the bacteria on the AD skin to control flare-ups and to offer a strong safety profile that allows for long-term continuous use.”
In the first of two cohorts in this study, researchers evaluated the efficacy and safety of the twice-daily topical in 41 patients for 4 weeks.
Results showed that 53.3% of patients aged 2 to 17 years treated with AB-101a achieved a 1-point decrease in IGA score by day 29 compared with 0% of those treated with vehicle. Also, 60% of adults using the topical achieved the same compared with 37.5% using vehicle.
According to the World Congress of Dermatology presentation, all secondary endpoints showed positive trends vs. vehicle, including 50% improvement in both EASI and body surface area, as well as improvement in secondary infection rating scale. Additionally, patients treated with AB-101 experienced fast itch reduction by day 4, with some also achieving 75% improvement in EASI.
The only drug-related adverse events reported were three cases of mild stinging upon application and one headache.
“The results of the first cohort of AB-101a demonstrate its safety profile and show statistically significant effectiveness on par or superior to approved topical AD drugs, including JAK inhibitors, for mild to moderate AD,” Koller told Healio.
The second cohort of the trial is an open-label study evaluating patients with mild, moderate and severe AD. Comprised of 20 patients, results from this study were scheduled to be presented at The Society for Pediatric Dermatology Annual Meeting, according to the press release.
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