Phase 2a Clinical Trial Enrollment for AD Passes Halfway Point

Alphyn Biologics announced that the enrollment in its phase 2a clinical trial of AB-101a for the treatment of mild-to-moderate atopic dermatitis (AD) has passed the halfway mark.¹ The randomized, vehicle-controlled, double-blind trial is evaluating AB-101a for the treatment of AD in adults and children, aged 2 years and older. The study is especially unique because it is also evaluating a subset of patients who suffer from bacterial infections associated with AD.

According to Alphyn, many newer AD therapy options only focus on the immune system modulation of AD. There are no drugs currently available that treat both immune modulation and bacterial infections commonly seen in AD lesions. Overall, AB-101a is designed to relieve inflammation, reduce itching, and treat skin infections. The “all-in-one" approach will provide patients with an effective and safe solution to reducing many of their bothersome AD symptoms.

Patients with AD commonly experience bacterial infections, most often associated with Staphylococcus aureus (Staph), including methicillin-resistant Staph (MRSA). These common bacteria live on the skin, releasing toxins that trigger inflammation and itch in patients with AD, making them more vulnerable to exacerbation and infection, and preventing healing.

The multi-site clinical trial is evaluating the treatment protocol of the topical AB-101a, in patients aged 2 years old and above in 2cohorts. The 2 cohorts include non-infected AD patients and infected AD patients. The non-infected cohort has completed patient enrollment, and the first patient has been dosed in the infected cohort.

Alphyn believes AMB-101a is unique due to its safety, efficacy, convenience, and accessibility to a broader population. AMB-101a is also designed for pediatric patients with AD, a group of AD patients that needs better treatment options. AB-101a was developed using Alphyn's proprietary AB-101 platform. The platform has multiple bioactive compounds. AB-101a has demonstrated a strong safety profile and is in development to uniquely target AD's immune system and bacterial components.

Reference:

1. Alphyn Biologics announces enrollment passes halfway point in phase 2a clinical trial of mild-to-moderate atopic dermatitis treatment. PR Newswire. Published October 18, 2022. Accessed October 18, 2022. https://www.prnewswire.com/news-releases/alphyn-biologics-announces-enrollment-passes-halfway-point-in-phase2a-clinical-trial-of-mild-to-moderate-atopic-dermatitis-treatment-301651511.html