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Alphyn Biologics, a clinical-stage dermatology company developing the first of its kind to treat multi-target drug therapies, today announced that it is more than halfway
through its Phase 2a clinical trial of AB-101a for mild to moderate atopic dermatitis (AD).
This randomized, vehicle-controlled, double-blind trial evaluated AB-101a for the treatment of atopic dermatitis in adults and children older than 2 years of age, and specifically enrolled a subset of
patients with bacterial infections commonly associated with the disease.
Shalini Gupta, MD, dermatologist, member of AAlphyn Investor Angel Physicians Fund, said: "While most therapies focus on the modulation of the immune system of AD, there is currently no available drug that can simultaneously treat bacterial infections
in AD lesions in most patients through immunomodulation.
We are excited about the promise of AB-101a and expect it to be extraordinarily effective in relieving inflammation, reducing itching, and treating skin infections, a potentially effective and safe all-in-one approach
.
" "
A growing body of research has shown that AD has a bacterial component
in addition to its immune system components.
1 Patients with AD often suffer from bacterial infections, most commonly with Staphylococcus aureus, including methicillin-resistant Staphylococcus aureus (MRSA).
These common bacteria parasitize the skin, release toxins that cause inflammation and itching in AD patients, making these patients prone to aggravation and infection, and preventing the condition from healing
.
This multi-center clinical trial will evaluate
topical AB-101a in patients 2 years of age and older, including uninfected AD patients and infected AD patients.
The uninfected population has completed patient recruitment, and the first patient in the infected population has received the drug
.
Neal Koller, CEO of Alphyn, said: "Safety is an important issue
in the market associated with many AD drugs.
We strongly believe that AB-101a will provide patients and their physicians with a compelling and unique treatment option
.
This treatment option is safe, effective, easy to operate, and accessible to a wide range of people, including children, for whom the need for new therapies is critical
.
"
The AB-101a was developed
using Alphyn's proprietary AB-101 platform.
With a variety of bioactive compounds, the platform therefore has multiple mechanisms of action that potentially address multiple issues
for any target disease.
Due to the strong safety profile of AB-101, Alphyn initiated a 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