Azitra Receives Fast Track Designation for ATR-04 for Skin Rash from EGFR Inhibitors
September 18 2024 - 9:00AM
Business Wire
Azitra, Inc. (NYSE American: AZTR), a clinical-stage
biopharmaceutical company focused on developing innovative
therapies for precision dermatology, today announced the U.S. Food
and Drug Administration (FDA) has granted Fast Track Designation
for topically applied ATR-04 to treat moderate to severe Epidermal
Growth Factor Receptor inhibitor (EGFRi) associated dermal
toxicity.
Francisco Salva, Azitra’s CEO, stated, "We are thrilled to
announce the FDA has granted Fast Track designation to ATR-04,
demonstrating that the FDA recognizes the unmet need for treatment
of EGFRi-associated skin rash. Many cancer patients receive EGFR
inhibitors, which often have significant side effects, resulting in
rashes that require off-label treatment with antibiotics, steroids
or other medications, or discontinuation of EGFRi therapy. The skin
toxicity creates a high burden for these cancer patients, with a
profound impact on their quality of life. We look forward to
potentially accelerating the development of ATR-04 to treat this
condition.”
The FDA's Fast Track program aims to facilitate the development,
and expedite the review, of novel potential therapies that are
designed to treat serious conditions and have the potential to
address significant, unmet medical needs. This may include more
frequent meetings with the FDA and eligibility for accelerated
approval or rolling review.
ATR-04 is a live biotherapeutic product candidate containing an
isolated, naturally derived Staphylococcus epidermidis strain that
was engineered to be safer by deleting an antibiotic resistance
gene and engineering auxotrophy to control the growth of ATR-04.
ATR-04 is in development for EGFRi-associated skin rash, which is
caused by the suppression of skin immunity and subsequent
inflammation and often elevated levels of IL-36γ and
S. aureus. Approximately 150,000 patients are affected by
EGFRi-induced skin toxicity in the United States, representing a
>$1 billion market opportunity.
Azitra plans to initiate a multicenter, randomized, controlled
Phase 1/2 clinical trial of ATR-04 in patients with dermal toxicity
due to EGFR inhibitors by the end of 2024.
About Azitra, Inc.
Azitra, Inc. is an early-stage clinical biopharmaceutical
company focused on developing innovative therapies for precision
dermatology using engineered proteins and topical live
biotherapeutic products. The Company has built a proprietary
platform that includes a microbial library comprised of
approximately 1,500 unique bacterial strains that can be screened
for unique therapeutic characteristics. The platform is augmented
by artificial intelligence and machine learning technology that
analyzes, predicts and helps screen the Company's library of
strains for drug like molecules. The Company's initial focus is on
the development of genetically engineered strains of Staphylococcus
epidermidis, or S. epidermidis, which the Company considers to be
an optimal therapeutic candidate species for engineering of
dermatologic therapies. 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 clinical
development of our ATR-04 product candidate and the expected
benefits of the FDA’s grant of Fast Track designation for
ATR-04.
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 not realize the potential
benefits of the FDA’s grant of Fast Track designation for ATR-04;
we may fail to successfully complete our Phase 1/2 trial for ATR-04
and preclinical studies of other product candidates; we may not be
able to obtain additional working capital with which to continue
our current operations and clinical trials as and when needed;
success in early phases of preclinical and clinical trials do not
ensure later clinical trials will be successful; no drug product
incorporating our engineered proteins or topical live
biotherapeutic products has received FDA premarket approval or
otherwise been incorporated into a commercial drug product; and
those other risks disclosed or incorporated in the section “Risk
Factors” included in our Form 10-Q filed with the SEC on August 12,
2024. Azitra explicitly disclaims any obligation to update any
forward-looking statements except to the extent required by
law.
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version on businesswire.com: https://www.businesswire.com/news/home/20240918592771/en/
Norman Staskey Chief Financial Officer staskey@azitra.com Hayden
IR James Carbonara (646)-755-7412 james@haydenir.com
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