Azitra Announces First Patient Screened and Scheduled to Enroll in Phase 1b Trial of ATR-12 for Netherton Syndrome
August 20 2024 - 4:15PM
Business Wire
Azitra, Inc. (NYSE American: AZTR), a precision dermatology
company announced that it has successfully screened the first
patient in its Phase 1b clinical trial evaluating ATR-12 for the
treatment of Netherton syndrome. The patient is scheduled to
initiate treatment by the end of the month. The study is designed
to enroll approximately 12 adult patients with twice-daily
treatment for 14 days, with primary endpoints focusing on safety
and tolerability, and secondary and exploratory endpoints assessing
efficacy signals and biomarkers. Azitra expects to report interim
safety data from the Phase 1b trial in early 2025 with full results
anticipated in the second half of 2025.
ATR-12 is Azitra's lead candidate, a proprietary strain of
Staphylococcus epidermidis engineered to express therapeutic levels
of an active subunit of the LEKTI protein to treat Netherton
syndrome, a chronic genetic skin disease that can be life
threatening.
"Enrolling the first patient in our Phase 1b trial of ATR-12
will mark a significant milestone for Azitra and, more importantly,
for patients suffering from Netherton syndrome, who currently have
limited treatment options," said Travis Whitfill, founder and COO
of Azitra. "Our recent preclinical data demonstrate ATR-12's
potential to effectively deliver an active LEKTI subunit into the
skin and address the underlying mechanisms of Netherton
syndrome."
Mary Spellman MD, Azitra’s acting CMO, added, “We are thrilled
to begin this clinical trial of ATR-12 in Netherton syndrome
patients. These patients suffer from poor quality of life and often
debilitating disease, and this trial will inform future studies for
the treatment of Netherton syndrome in pediatric patients and for
longer treatment durations.”
The Phase 1b trial (NCT06137157) is a multicenter, randomized,
double-blind, vehicle-controlled study in approximately 12 adult
patients with Netherton syndrome. Patients will be treated with 109
CFU / g twice daily with ATR-12 or its vehicle control on the
contralateral side of the body twice daily for 14 days. The primary
objective is to assess the safety and tolerability of topical
ATR-12 application. Secondary objectives include evaluating
efficacy signals (e.g., investigator and patient global
assessments) and skin pharmacokinetics of the LEKTI subunit.
Additional exploratory objectives include evaluating
pharmacodynamic parameters, biomarkers, anti-LEKTI response, and
cytokine responses.
The trial design is supported by compelling preclinical data
recently presented at the American Society of Gene and Cell Therapy
(ASGCT) 2024 Annual Meeting. Key findings included:
- Topical application of ATR-12 in preclinical models reduced
IL-36γ by 93% compared to skin extracts induced to overexpress
IL-36γ
- ATR-12 significantly reduced protease activity in skin samples
compared to a Netherton syndrome model skin (p<0.01)
- ATR-12 produced higher amounts of LEKTI subunit compared to
topical application of LEKTI protein alone (6.0 µg vs. 2.3 µg,
respectively, p<0.01) after 24 hours and resulted in deeper skin
penetration of LEKTI
About ATR-12
ATR-12 (also known as ATR12-351) is an engineered strain of S.
epidermidis that expresses an active subunit of human
lympho-epithelial Kazal-type-related inhibitor (LEKTI) protein,
which is missing in patients with Netherton syndrome, a chronic and
sometimes fatal disease of the skin estimated to affect
approximately one to nine in every 100,000. ATR-12 has been
engineered to deliver missing LEKTI protein when applied topically
to Netherton syndrome patients. Azitra has an open IND for a Phase
1b clinical trial in adult patients (NCT06137157). Azitra has
secured clinical sites and identified Netherton syndrome patients
for enrollment in its 12-patient, Phase 1b clinical trial, which
will assess safety, tolerability, and efficacy endpoints. Azitra
expects to announce initial safety data before year end.
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 1b study of
ATR-12 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 1b trial for ATR-12 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240821927788/en/
Investor Relations Contact: Norman Staskey Chief
Financial Officer staskey@azitrainc.com
Hayden IR James Carbonara (646) 755-7412 james@haydenir.com
Azitra (AMEX:AZTR)
Historical Stock Chart
From Sep 2024 to Oct 2024
Azitra (AMEX:AZTR)
Historical Stock Chart
From Oct 2023 to Oct 2024