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

Alphyn Biologics

PR98331

 

ANNAPOLIS, Md., Oct. 18, 2022 /PRNewswire=KYODO JBN/ --

 

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

    infection

 

Alphyn Biologics (

https://c212.net/c/link/?t=0&l=en&o=3680049-1&h=958198912&u=https%3A%2F%2Falphynbiologics.com%2F&a=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.

 

Logo -

https://mma.prnewswire.com/media/1899346/Alphyn_Biologics__LLC__Logo_Hi_Res_Transparent_Bckgrd_Logo.jpg

 

 

"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. (1) Patients with AD frequently

experience bacterial infection, most often associated with Staphylococcus

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.

 

SOURCE  Alphyn Biologics

 

CONTACT: Corporate, Neal Koller, nkoller@alphynbiologics.com, (410) 690-8687;

Media, Susan Thomas, susan@endpointcommunications.net, (619) 540-9195

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