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Azitra Awarded NIH SBIR Grant to Develop Microbiome-based Therapeutic for Netherton Syndrome

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--The Jackson Laboratory to collaborate with Azitra --

Azitra,
Inc.
, today announced that the company has been awarded a $225,000
Small Business Innovation Research (SBIR) Phase I award (R43AR073562)
from the National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS) of the National Institutes of Health (NIH). The grant
will support development of Azitra's skin microbiome therapeutic,
AZT-02, a Live Biotherapeutic Product (LBP) for treatment of Netherton
Syndrome (NS), a severely disabling orphan skin disease. Azitra's Chief
Scientific Officer, Travis Whitfill and The
Jackson Laboratory's (JAX)
skin microbiome expert, Julia
Oh,
are the principal investigators on this grant.

"I'm thrilled to receive this funding and am honored to be joined by Dr.
Julia Oh at JAX for this research," said Travis Whitfill, MPH, Founder
and Chief Scientific Officer, Azitra. "Although NS is extremely rare, it
is a severe, unmet need and patients are desperate for new treatment
options. We hope to bring forward a novel, microbe-based therapy,
AZT-02, to deliver missing proteins as a viable therapeutic strategy.
This project demonstrates the versatility and importance of our
microbe-based platform to deliver proteins to the skin."

AZT-02 is a proprietary strain of Staphylococcus epidermidis,
a bacterium naturally found in the skin microbiome, engineered to
express therapeutic levels of LEKTI protein. LEKTI is a protease
inhibitor essential to maintaining skin structure, which is missing in
patients suffering from NS.

Under the grant, Azitra will collaborate with JAX to demonstrate that S.
epidermidis
can secrete functional LEKTI protein and that these
bacteria can improve phenotypic severity of the disease in a preclinical
model.

"There is increasing evidence that the microbiome plays a vital role in
many diseases, and the potential of rationally designing microbes to
express proteins that can treat a skin disorder such as NS is very
exciting," said Julia Oh, Ph.D., JAX assistant professor. "I am looking
forward to collaborating with Azitra as we seek to gain proof-of-concept
that the topical application of an engineered S. epidermidis that
secretes LEKTI can resolve NS symptoms in a preclinical model."

NS is a genetic disorder caused by mutations in the SPINK5 gene,
which provides instructions for making a protein called LEKTI. The
disorder affects the skin, hair, and immune system. Approximately 1
in 200,000
newborns are born with the disease, and symptoms
including red, scaly skin, typically become apparent in early childhood.
Complications are frequent and newborns with the disorder are at risk of
becoming dehydrated and developing infections in the skin or throughout
the body (sepsis), which can be life threatening. There are currently
few treatment options for NS.

"There is a tremendous unmet medical need for a safe, efficacious
approach to treating many skin disorders, including NS, which is a
debilitating illness," said Leonard M. Milstone, M.D., Senior Research
Scientist in Dermatology at Yale University. "Current treatment options
for many skin diseases fail to address the underlying causative
pathophysiologies, and AZT-02 provides a refreshing new approach to
addressing such problems and improving care for NS patients."

About Azitra
Azitra, Inc. is a preclinical stage
biotechnology company combining the power of the microbiome with
cutting-edge genetic engineering to treat skin disease. The Company was
founded in 2014 by scientists from Yale University and works with
world-leading scientists in dermatology, microbiology, and genetic
engineering to advance its consumer health and pharmaceutical programs
to treat atopic dermatitis, dry skin and targeted orphan indications.
For more information visit www.azitrainc.com.

About The Jackson Laboratory
The
Jackson Laboratory
is an independent, nonprofit biomedical research
institution based in Bar Harbor, Maine, with a National Cancer
Institute-designated Cancer Center, a facility in Sacramento,
California, and a genomic medicine institute in Farmington, Connecticut.
It employs 2,100 staff, and its mission is to discover precise genomic
solutions for disease and empower the global biomedical community in the
shared quest to improve human health. To learn more, please visit www.jax.org.

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