Azitra is developing ATR04-484 for the treatment of EGFR
inhibitor-associated rash with plans to dose first patient in Phase
1/2 trial in the first half of 2025
BRANFORD, Conn.,
April 25,
2025 /PRNewswire/ -- Azitra, Inc. (NYSE American:
AZTR), a clinical stage biopharmaceutical company focused on
developing innovative therapies for precision dermatology, today
announced that an abstract detailing the Phase 1/2 clinical trial
of ATR04-484 in EGFR inhibitor ("EGFRi")-associated rash has been
accepted for presentation at the 2025 American Society of Clinical
Oncology (ASCO) Annual Meeting being held May 30-June 3, 2025 in Chicago.
"We look forward to presenting an update on the ATR-04 program
at ASCO as we plan to dose the first patient in the first half of
2025," said Francisco Salva, CEO of Azitra. "ASCO is widely
regarded as the most prestigious cancer research conference in the
world, and we are eager to educate leaders in the oncology
community on the potential of ATR04-484 to treat the unique
dermatologic toxicities that often accompany EGFRi treatments,
which can hamper treatment efforts and cause significant physical
and psychological discomfort for patients."
ATR04-484 is a live biotherapeutic product candidate including
an isolated, naturally derived Staphylococcus epidermidis
strain that was engineered to be safe by deleting an antibiotic
resistance gene and engineering auxotrophy to control the growth of
ATR04-484. ATR04-484 is in development for EGFRi-associated skin
rash, which is associated with the suppression of skin immunity by
EGFR inhibitors and subsequent inflammation, often accompanied by
elevated levels of IL-36γ and S. aureus. Azitra has received
Fast Track designation from the FDA for EGFRi associated rash and
has initiated a Phase 1/2 clinical study in patients with EGFRi
rash with the first patient expected to be dosed in the first half
of 2025.
EGFR inhibitors are a class of cancer drugs that target and
block the activity of the EGFR protein, which plays a crucial role
in cell growth and survival. They are primarily used to treat
certain types of cancer, including non-small cell lung cancer
(NSCLC) and colorectal cancer.
The full ASCO abstracts will be available on May 22, 2025, after 5 p.m.
ET. Abstract titles are available at:
https://www.asco.org/abstracts.
About Azitra, Inc.
Azitra, Inc. is a clinical stage biopharmaceutical company
focused on developing innovative therapies for precision
dermatology. The Company's lead program, ATR-12, uses an engineered
strain of S. epidermidis designed to treat Netherton
syndrome, a rare, chronic skin disease with no approved treatment
options. Netherton syndrome may be fatal in infancy with those
living beyond a year having profound lifelong challenges. The
ATR-12 program includes a Phase 1b
clinical trial in adult Netherton syndrome patients. ATR-04,
Azitra's additional advanced program, utilizes another engineered
strain of S. epidermidis for the treatment of EGFR inhibitor
("EGFRi") associated rash. Azitra has received Fast Track
designation from the FDA for EGFRi associated rash, which impacts
approximately 150,000 people in the U.S. Azitra has an open IND for
its ATR-04 program in patients with EGFRi associated rash. The
ATR-12 and ATR-04 programs were developed from Azitra's proprietary
platform of engineered proteins and topical live biotherapeutic
products that includes a microbial library comprised of
approximately 1,500 bacterial strains. The platform is augmented by
artificial intelligence and machine learning technology that
analyzes, predicts, and helps screen the library of strains for
drug like molecules. For more information, please visit
https://azitrainc.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended. These statements may be identified by words such
as "aims," "anticipates," "believes," "could," "estimates,"
"expects," "forecasts," "goal," "intends," "may," "plans,"
"possible," "potential," "seeks," "will," and variations of these
words or similar expressions that are intended to identify
forward-looking statements. Any such statements in this press
release that are not statements of historical fact may be deemed to
be forward-looking statements. These forward-looking statements
include, without limitation, statements regarding the expected
timing of the abstract detailing the Phase 1/2 clinical trial for
our ATR-04 program, the initiation of dosing in the Phase 1/2
clinical trial for our ATR-04 program, and statements about our
clinical and preclinical programs, and corporate and
clinical/preclinical strategies.
Any forward-looking statements in this press release are based
on current expectations, estimates and projections only as of the
date of this release and are subject to a number of risks and
uncertainties that could cause actual results to differ materially
and adversely from those set forth in or implied by such
forward-looking statements. These risks and uncertainties include,
but are not limited to that we may fail to present this abstract
detailing the Phase 1/2 clinical trial or, if we are able to do so,
that the abstract will be favorably received; we may experience
delays in the dosing the first patient in this Phase 1/2 trial; our
product candidates may not be effective; there may be delays in
regulatory approval or changes in regulatory framework that are out
of our control; our estimation of addressable markets of our
product candidates may be inaccurate; we may fail to timely raise
additional required funding; more efficient competitors or more
effective competing treatment may emerge; we may be involved in
disputes surrounding the use of our intellectual property crucial
to our success; we may not be able to attract and retain key
employees and qualified personnel; earlier study results may not be
predictive of later stage study outcomes; and we are dependent on
third-parties for some or all aspects of our product manufacturing,
research and preclinical and clinical testing. Additional risks
concerning Azitra's programs and operations are described or
incorporated by reference in our annual report on Form 10-K filed
with the SEC on February 24, 2025.
Azitra explicitly disclaims any obligation to update any
forward-looking statements except to the extent required by
law.
Contact
Norman
Staskey
Chief Financial
Officer
staskey@azitrainc.com
Investor Relations
Tiberend Strategic Advisors,
Inc.
Jon
Nugent
205-566-3026
jnugent@tiberend.com
Media Relations
Tiberend Strategic Advisors,
Inc.
Casey
McDonald
646-577-8520
cmcdonald@tiberend.com
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SOURCE Azitra, Inc.
