Alphyn Biologics Announces Enrollment Passes Halfway Point in Phase2a Clinical Trial of Mild-to-Moderate Atopic Dermatitis Treatment

Study evaluates AB-101a for patients with and without concurrent bacterial infection

ANNAPOLIS,Md.,Oct. 18,2022 -- Alphyn Biologics,a clinical-stage dermatology company developing first-in-class multi-target therapeutics,announced today that enrollment in its Phase2a clinical trial of AB-101a for mild-to-moderate atopic dermatitis (AD) has passed the halfway point. The randomized,vehicle-controlled,double-blind trial is evaluating AB-101a for the treatment of AD in adults and children,starting at age 2 years old,and uniquely includes a subset of patients who are suffering from bacterial infections commonly associated with the disease.

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

A growing body of research demonstrates that in addition to AD's immune system component,AD has a bacterial component.1Patients with AD frequently experience bacterial infection,most often associated withStaphylococcus aureus(Staph),including methicillin-resistant Staph (MRSA). These common bacteria live on the skin,giving off toxins that trigger inflammation and itch in patients with AD,making them prone to exacerbation and infection,and preventing healing.

The multi-site clinical trial will evaluate the treatment protocol of AB-101a,a topical,in patients ages 2 and above in two cohorts,including 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.

"Safety is a significant concern with many AD drugs on the market," said Alphyn CEO Neal Koller. "We believe that AB-101a will provide patients and their physicians a compelling and unique treatment option that is safe,effective,convenient,and accessible to a broad population,including children,for which 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 therefore 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 at 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 first-in-class multi-target therapeutics for severe 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 in development to uniquely target AD's immune system and bacterial components,making it ideal for treating non-infected and infected AD. Alphyn's AB-101 platform has multiple bioactive compounds and therefore multiple mechanisms of action to support a robust pipeline of dermatologic therapeutics that have potential safety,efficacy and regulatory marketing authorization advantages. Alphyn is based in Annapolis,Maryland and Cincinnati,Ohio,and has a wholly owned Australia subsidiary. The company became operational in 2020 and has raised approximately $6.9 million.