Azitra, Inc. Announces Positive Preclinical Data of ATR-12 and Clinical Design in Netherton Syndrome Presented at the ASGCT Annual Meeting
10 Maggio 2024 - 2:00PM
Business Wire
- ATR-12 has nanomolar inhibition of key protease in vitro that
drives Netherton syndrome
- Topical application of ATR-12 to ex vivo human skin results in
superior LEKTI delivery compared to topical LEKTI application
- ATR-12 reduces IL-36g, a pro-inflammatory cytokine that drives
Netherton syndrome
- Safe and well tolerated in minipigs
Azitra, Inc. (NYSE American: AZTR), a clinical-stage
biopharmaceutical company focused on developing innovative
therapies for precision dermatology, today announced preclinical
data from the Company’s platform and pipeline. The data are being
presented on Friday, May 10, 2024, in two oral sessions entitled
“Engineered Staphylococcus Epidermidis as a Protein Delivery System
for Treating Skin Diseases” and “Staphylococcus epidermidis Strain
Expressing LEKTI-D6 (ATR12-351) for Netherton Syndrome” at the
American Society of Gene and Cell Therapy (ASGCT) 2024 Annual
Meeting in Baltimore, MD.
The data in the two oral presentations today showcase the
preclinical development of ATR-12 and the clinical study design of
a Phase 1b study in Netherton syndrome patients. In vitro data show
that LEKTI (lympho-epithelial Kazal-type-related inhibitor) protein
secreted by ATR-12 has nanomolar inhibition of a key protease that
drives Netherton syndrome, kallikrein (KLK) 5 (IC50=26 nM).
Additionally, in human ex vivo Netherton syndrome models, ATR-12
supernatant reduces protease activity nearly 7-fold to levels
comparable to healthy skin. Furthermore, in ex vivo human skin
models, ATR-12 led to a higher amount of LEKTI delivery to the skin
compared to topically applied LEKTI alone (6.1 µg/cm2 vs. 2.3
µg/cm2, p=0.008) after 24 hours and resulted in deeper
biodistribution of LEKTI. Application of ATR-12 in human skin cell
culture reduced IL-36γ by 92% compared to skin
extracts induced to overexpress IL-36γ. Topical
application of ATR-12 to in vitro human skin treated with erlotinib
reduced IL-36γ by 69%.
In studies conducted in minipigs with abraded skin, topical
application of ATR-12 resulted in 11.9 ng/cm2 of LEKTI on the
surface of the skin vs. 2.6 ng/cm2 in the vehicle group at day 14.
ATR-12 application was safe and well-tolerated in GLP toxicology
studies with minipigs.
The oral presentation entitled “Staphylococcus epidermidis
Strain Expressing LEKTI-D6 (ATR-12) for Netherton Syndrome” also
provides the study design for an active clinical trial of ATR-12 in
Netherton syndrome patients. The Phase 1b study (NCT06137157) is a
multicenter, randomized, double-blind, vehicle-controlled study in
adults (n=12) with Netherton syndrome. Patients will be treated
twice daily with 109 CFU / g ATR-12 for 14 days. The primary
objective is to assess the safety and tolerability of topical
application of ATR-12, and the secondary objectives are to evaluate
efficacy signals (e.g., investigator and patient global
assessments) and to evaluate the skin pharmacokinetics of LEKTI.
Exploratory objectives include the evaluation of pharmacodynamic
parameters, including anti-LEKTI response, cytokine responses,
biomarkers such as KLK5, KLK7, IL-36γ, trypsin-like
activity, and chymotrypsin-like activity.
“We are thrilled to announce full preclinical data around ATR-12
as well as our clinical plan in Netherton syndrome that demonstrate
proof-of-concept data supporting the use of genetically engineered
skin commensals to deliver proteins to the skin,” said Travis
Whitfill, Azitra’s co-founder and COO. “These data show the robust
preclinical activity of ATR-12 in Netherton syndrome models and
further supports the rationale behind our Phase 1b clinical trial
in Netherton syndrome patients.”
The presentations are now available on Azitra’s website at
https://ir.azitrainc.com/news-events/presentations.
About ATR-12
ATR-12 (also known as ATR12-351) is an engineered strain of S.
epidermidis that expresses a fragment 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, the filing of an IND application, and the presentation of
data from our Phase 1b for ATR-04, the IND filing for ATR-01, the
timing of having a signed license agreement with Bayer, and
statements about our clinical and pre-clinical programs, and
corporate and clinical/pre-clinical 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 pre-clinical 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 concerning Azitra's programs and
operations are described in its annual report on Form 10-K filed
with the SEC on March 15, 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/20240510005056/en/
Norman Staskey Chief Financial Officer staskey@azitrainc.com
Hayden IR James Carbonara (646) 755-7412 james@haydenir.com
Grafico Azioni Azitra (AMEX:AZTR)
Storico
Da Gen 2025 a Feb 2025
Grafico Azioni Azitra (AMEX:AZTR)
Storico
Da Feb 2024 a Feb 2025