— Phase II Grant to Advance Development of Live Biotherapeutic
Product Candidate for Netherton Syndrome —
FARMINGTON, Conn.–(BUSINESS WIRE)–Azitra,
Inc. today announced that the company has been awarded a Phase II
Small Business Innovation Research (SBIR) grant (#1853071) of $719,700
from the National Science Foundation (NSF). This grant will support the
advanced development of AZT-02 for treating the rare genetic skin
condition, Netherton syndrome (NS). AZT-02 is a topical ointment
composed of a proprietary strain of Staphylococcus epidermidis
(SE), a bacterium naturally found in the skin microbiome. The product
candidate is engineered to secret therapeutic levels of LEKTI, an
essential protein missing in newborns affected by NS.
The new grant will expand research previously supported by a Phase I
Small Business Technology Transfer (STTR) grant from NSF and a Phase I
SBIR Award from the National Institute of Arthritis and Musculoskeletal
and Skin Diseases (NIAMS) of the National Institutes of Health (NIH).
Principal investigators on the grant are Azitra’s Founder and Chief
Scientific Officer, Travis Whitfill, MPH, and Julia
Oh, Ph.D., a skin microbiome expert at The
Jackson Laboratory (JAX), an independent, nonprofit biomedical
research institution.
“We are very pleased to receive ongoing support from NSF for the
development of AZT-02,” said Mr. Whitfill. “This program is not only
intended to meet the needs of patients with a severe, unmet medical
need, but is also designed to confirm the promise of the Company’s core
technology: the use of microbiome-based systems to deliver therapeutic
proteins to the skin.”
NS is a genetic disorder that results from mutations in the SPINK5
gene, which is responsible for making the LEKTI protein. LEKTI is a
protease inhibitor essential for controlling the rate of skin shedding.
When LEKTI is absent, NS patients suffer rapid and uncontrolled loss of
skin tissue. NS affects the skin, hair and immune system and is a
life-long disease challenge. Approximately 1 in 200,000 children are
born with the disease and as many as 10% die in their first year of
life. Complications of NS are frequent, and newborns with the disorder
are at risk of becoming dehydrated and developing skin infections and/or
sepsis. Patients are at risk throughout their lives of life-threatening
adverse events. There are currently few treatment options for NS.
“Engineered live biotherapeutic products represent a novel approach that
leverages the skin microbiome for therapeutic purposes,” said Dr. Oh.
“An engineered commensal skin bacterium such as S. epidermidis
could offer important advantages over other methods of drug delivery, as
it will establish residence on the patient’s skin and continuously and
stably deliver therapeutic proteins in situ. Moreover, certain
strains of S. epidermidis are known to exhibit important,
beneficial immunomodulatory and anti-pathogen effects in the skin, which
are relevant to NS disease severity.”
About The Jackson Laboratory
The Jackson Laboratory (www.jax.org)
is an independent, nonprofit biomedical research institution with more
than 2,200 employees. With a mammalian genetics institute as its
headquarters campus in Bar Harbor, Maine, it has a genomic medicine
institute in Farmington, Conn. and production facilities in Sacramento,
Calif., and Ellsworth, Maine. Its mission is to discover precise genomic
solutions for disease and empower the global biomedical community in the
shared quest to improve human health. For more information, please visit www.jax.org.
About Azitra
Azitra, Inc. is a clinical-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, cancer
therapy associated skin rashes and targeted orphan indications. For more
information visit http://www.azitrainc.com.
About the NSF’s Small Business Programs
America’s Seed Fund powered by NSF awards $200 million annually to
startups and small businesses, transforming scientific discovery into
products and services with commercial and societal impact. Startups
working across almost all areas of science and technology can receive up
to $1.5 million in non-dilutive funds to support research and
development (R&D), helping de-risk technology for commercial success.
America’s Seed Fund is congressionally mandated through the Small
Business Innovation Research (SBIR) program. The NSF is an independent
federal agency with a budget of about $8.4 billion that supports
fundamental research and education across all fields of science and
engineering. For more information, visit seedfund.nsf.gov.
Contacts
Media Contacts:
Michelle Linn
Bioscribe, Inc.
774-696-3803
michelle@bioscribe.com