Paper highlights Zabalafin Hydrogel's
potential as a single topical atopic dermatitis therapy that
impacts the Staphylococcus aureus component and treats all other
disease symptoms across severity levels
ANNAPOLIS, Md., Nov. 1, 2024
/PRNewswire/ -- Alphyn Biologics, Inc., a clinical-stage
dermatology company developing first-in-class Multi-Target
Therapeutics®, announced today the publication of a
peer-reviewed paper in the Journal of Drugs in Dermatology
that highlights the potential of Zabalafin Hydrogel to manage the
Staphylococcus aureus (S. aureus)-driven mechanism
behind atopic dermatitis (AD), as well as treat all the additional
AD problems and severities, regardless of AD skin infection status.
The paper, titled "A Consensus on Staphylococcus aureus Exacerbated
Atopic Dermatitis and the Need for a Novel Treatment," underscores
the importance of managing the S. aureus-driven causes
of AD, S. aureus-related AD exacerbation, and the
S. aureus component in infected AD lesions to
comprehensively treat AD.
The panel of six leading pediatric dermatologists who researched
and authored the paper included Lawrence A.
Schachner, MD., Mercedes E.
Gonzalez, MD, Karan Lal, DO,
Adelaide A. Hebert, MD, Lawrence F. Eichenfield, MD, and Peter Lio, MD, with the assistance of
Anneke Andriessen, Ph.D. The
group presented a consensus of five statements on S.
aureus-driven AD exacerbation, challenges in current treatments
for AD skin that is infected, and new developments to improve
patient care and outcomes. The consensus statements offer
recommendations for treating patients having infected AD skin and
define a significant unmet need for a single topical AD therapeutic
effective against all AD symptoms regardless of infection status,
including AD pruritus, S. aureus-driven AD etiology and
exacerbation, infected AD skin, and AD inflammation. The
dermatologists reviewed data from Alphyn's Phase 2a clinical trials
and used a modified Delphi process comprising face-to-face expert
panel discussions and follow-up, along with a systemic literature
review to inform their recommendations.
"The skin microbiome is essential for skin barrier function.
Decreased diversity of the skin microbiome in AD correlates with
increased S. aureus on AD skin and increased AD
disease severity. Managing S. aureus on AD skin is
therefore central to effectively treating this chronic condition,
yet antibiotic stewardship is crucial," said Dr. Peter Lio. "The majority of today's AD therapies
target only one aspect of AD, inflammation, while topical or
systemic antibiotics treat AD skin infected by S.
aureus and its drug-resistant strains such as MRSA.
Zabalafin Hydrogel offers a promising alternative to
anti-inflammatory and antibiotic drugs by treating all the aspects
of AD, uniquely including S. aureus-driven AD and its
symptoms, and addresses the unmet need for a single topical AD
therapy that can treat the pruritus, inflammation, and dysbiosis
without systemic side effects."
Alphyn Chief Scientific Officer Gary
Pekoe, Ph.D., commented, "This paper authored by six of the
most well-respected pediatric dermatologists strongly supports the
evolution in AD treatment to focus on the bacterial cause of AD.
Our Zabalafin Hydrogel is at the forefront of this treatment
evolution, with its desirable properties of being natural based,
treating the S. aureus AD problem directly, treating AD itch
directly, and directly treating AD inflammation. The paper presents
important insights into S. aureus-driven AD etiology and
exacerbation, the challenges of treating AD-infected skin, and the
need for an effective and comprehensive AD treatment that has a
safety, side effect, and patient tolerability profile suitable for
long-term and continuous use in the youngest of children."
Zabalafin Hydrogel is a novel, first-in-class complex
single-source botanical drug with multiple bioactive compounds that
provide multiple mechanisms of action, including anti-pruritic,
antibacterial, and anti-inflammatory activity. Two Phase 2a
clinical trials met all primary and secondary endpoints, showing
clinically relevant improvements in itch, patient-assessed
quality-of-life indicators, inflammation, and safety, with minimal
side effects and strong patient tolerability. The company plans
Phase 2b clinical trials next year to
further demonstrate its potential as the drug of choice for AD.
Zabalafin Hydrogel is derived from the company's Zabalafin
Platform.
ABOUT ALPHYN BIOLOGICS
Alphyn Biologics, Inc. is a
clinical-stage dermatology company developing first-in-class
Multi-Target Therapeutics® for severe and prevalent skin
diseases based on its Zabalafin Platform. Its lead product
candidate, Zabalafin Hydrogel, is being developed as a topical
treatment for atopic dermatitis (AD), the most common form of
eczema.
Zabalafin Hydrogel has demonstrated strong efficacy in Phase 2a
clinical trials, and the company believes it will be the first
therapeutic for AD to directly treat AD's itch and directly treat
bacteria that are increasingly thought to cause AD's inflammation
and flares. It also directly treats infected AD skin and directly
treats AD's inflammation. Clinical trial results of Zabalafin
Hydrogel suggest it has the potential to be the first AD treatment
that is worry-free for long-term, continuous use.
Alphyn's Zabalafin Platform has multiple bioactive compounds
and, therefore, multiple mechanisms of action to support a robust
pipeline of dermatologic therapeutics that have potential safety,
side effect, patient tolerability, efficacy, and regulatory
marketing authorization advantages. Alphyn is based in Annapolis, Maryland, and Cincinnati, Ohio, and has wholly owned
subsidiaries in Australia and
Austria. The company became
operational in 2020 and has raised approximately $16 million.
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SOURCE Alphyn Biologics, Inc.