Azitra Receives Study May Proceed letter from the FDA for IND to Treat Skin Rash from EGFR Inhibitors
August 22 2024 - 9:00AM
Business Wire
- New investigational new drug (IND) application cleared to
proceed by the US FDA for a Phase 1/2 clinical study of ATR-04 for
moderate to severe EGFR inhibitor (“EGFRi”) associated dermal
toxicity.
- There are an estimated 150,000 patients with EGFRi-associated
skin rash in the US, representing a >$1 billion global market
size.
- Preclinical data show ATR-04 reduces IL-36γ and Staphylococcus
aureus, key drivers of EGFRi-associated skin rash.
Azitra, Inc. (NYSE American: AZTR), a clinical-stage
biopharmaceutical company focused on developing innovative
therapies for precision dermatology, today announced the clearance
of an investigational new drug (IND) application to U.S. Food and
Drug Administration (FDA) for a first-in-human Phase 1/2 clinical
study of ATR-04 for moderate to severe EGFRi associated dermal
toxicity.
Francisco Salva, Azitra’s CEO, stated, "We are delighted to
announce a new IND clearance in an indication with high unmet need.
Many cancer patients receive EGFR inhibitors, which are efficacious
for certain cancers. However, these EGFR inhibitors often have
significant side effects, resulting in rashes that require
treatment with antibiotics, steroids or other medications. In some
cases, discontinuation of cancer therapy with the EGFR inhibitors
is necessary. There are no approved therapies for this skin
toxicity, and it is a high burden for these cancer patients. We are
excited to expand Azitra’s clinical pipeline with this IND.”
ATR-04 is a live biotherapeutic product candidate including 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 by EGFRis and subsequent
inflammation and often elevated levels of IL-36γ and
S. aureus. There are approximately 150,000 patients suffering from
EGFRi-induced skin toxicity in the United States, representing a
>$1 billion market opportunity.
Earlier this year, Azitra announced the preclinical data around
ATR-04 at the Society for Investigative Dermatology (SID) annual
meeting and the Annual Meeting for the American Society of Cell and
Gene Therapy, showing significant reductions in IL-36γ
and methicillin-resistant S. aureus (MRSA) in preclinical
models.
Following the clearance of the IND, Azitra plans to initiate a
multicenter, randomized, controlled Phase 1/2 clinical trial of
ATR-04 in patients undergoing EGFR inhibitors with dermal toxicity
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 expected
timing of the presentation of data from the Phase 1/2 study of
ATR-04 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 successfully complete
our Phase 1/2 trial for ATR-04 and preclinical studies of other
product candidates and obtain required approval before
commercialization; 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 are described 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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Company Contact Norman Staskey Chief Financial Officer
staskey@azitra.com
Hayden IR James Carbonara (646)-755-7412 james@haydenir.com
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