Alphyn Biologics Announces Enrollment Passes Halfway Point in Phase2a Clinical Trial of Mild-to-Moderate Atopic Dermatitis Treatment
PR98331
ANNAPOLIS, Md., Oct. 18, 2022 /PRNewswire=KYODO JBN/ --
--Study evaluates AB-101a for patients with and without concurrent bacterial
infection
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 -
"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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