-Alphyn Biologics Announces Passage of Phase 2a Clinical Trial of Treatment of Mild to Moderate Atopic Dermatitis

Study Evaluates AB-101a in Patients With and Without Concurrent Bacterial Infection

ANNAPOLIS, Md., Oct. 19, 2022 /PRNewswire/ -- Alphyn Biologics, a clinical-stage dermatology company developing world-class multi-target therapies, today announced enrollment in its Phase 2a clinical trial of AB-101a for mild to moderate atopic dermatitis (AD) it has passed the midpoint. The randomized, double-blind, vehicle-controlled trial is evaluating AB-101a for the treatment of AD in adults and children, 2 years of age and older, and exclusively includes a subset of patients with commonly reported bacterial infections. associated with the disease.

"While most therapies focus on immune system modulation of AD, there are currently no drugs available that simultaneously treat through immune modulation as well as the bacterial infection present in AD lesions of most patients. patients," said Dr. Shalini Gupta, a dermatologist and member of the Angel Physicians Fund, an investor in Alphyn. "We are excited about the prospects for AB-101a and anticipate that it will be remarkable in its ability to relieve inflammation, reduce itching and treat skin infection - a potentially effective and safe approach all in one."

A growing body of research shows that, in addition to the immune system component of AD, AD has a bacterial component.1 AD patients frequently experience bacterial infections, most associated with Staphylococcus aureus (staphylococcus), including methicillin-resistant staphylococcus (MRS). These common bacteria live on the skin, emitting toxins that trigger inflammation and itching in AD patients, making them prone to flare-ups and infection, and preventing healing.

The multicenter clinical trial will evaluate the treatment protocol of AB-101a, a topical, in patients 2 years of age and older in two cohorts, including uninfected AD patients and infected AD patients. The uninfected cohort has completed patient enrollment, and the first patient has been dosed in the infected cohort.

"Safety is a major concern with many AD drugs on the market," said Alphyn CEO Neal Koller. "We believe that AB-101a will provide patients and their physicians with a unique and compelling treatment option that is safe, effective, convenient and accessible to a broad population, including children, for whom the need for new treatments is critical."

AB-101a was developed using Alphyn's proprietary AB-101 platform. The platform has multiple bioactive compounds and thus multiple mechanisms of action to potentially address multiple problems of any target disease. Due to the strong safety profile of AB-101, Alphyn began its clinical trial program in phase 2.

1 Staphylococcus aureus and Atopic Dermatitis: A Complex and Evolving Relationship. Joan A. Geoghegan, Alan D. Irvine and Timothy J. Foster. Trends in Microbiology. 2018 Jun;26(6):484-497. doi: 10.1016/j.tim.2017.11.008. Epub 2017 Dec 9

ABOUT ALPHYN BIOLOGICS

Alphyn Biologics is a clinical-stage dermatology company developing a world-class multi-target therapy for serious and prevalent skin diseases based on its AB-101 platform. Its lead product candidate, AB-101a, is being developed as a topical treatment for atopic dermatitis (AD), the most common form of eczema. AB-101a has demonstrated a strong safety profile and is being developed to exclusively target the immune system and bacterial components of AD, making it ideal for treating infected and uninfected AD. Alphyn's AB-101 platform has multiple bioactive compounds and thus multiple mechanisms of action to support a robust portfolio of dermatological therapeutics with potential benefits in terms of safety, efficacy and market clearance. Alphyn is headquartered in Annapolis, Maryland and Cincinnati, Ohio, with its own subsidiary in Australia. The company went live in 2020 and has raised approximately $6.9 million.

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