Azitra, Inc. Announces Positive Preclinical Data from ATR-04 Presented at the Society of Investigative Dermatology Annual Meeting
Azitra (NYSE American: AZTR), a clinical-stage biopharmaceutical company, announced positive preclinical data for ATR-04, aimed at treating EGFR inhibitor-induced dermal toxicity. This condition affects about 150,000 patients in the US. The data, presented at the Society of Investigative Dermatology 2024 Annual Meeting, showed ATR-04 reducing methicillin-resistant S. aureus (MRSA) by 99% in ex vivo pig skin and reducing the pro-inflammatory cytokine IL-36γ by 75% in treated human skin models. Additionally, ATR-04 increased human beta defensin 18-fold compared to the vehicle in human skin models. These results support an upcoming IND application to the FDA for a Phase 1b trial in patients undergoing EGFR inhibitors with dermal toxicity.
- ATR-04 reduced methicillin-resistant S. aureus (MRSA) by 99% on ex vivo pig skin.
- ATR-04 reduced IL-36γ by 75% in human skin models treated with erlotinib.
- ATR-04 increased human beta defensin 18-fold compared to the vehicle in human skin models.
- Data presentation supports an upcoming IND application to the FDA for Phase 1b trials.
- ATR-04 addresses multiple drivers of EGFRi-induced skin toxicity.
- Data is still in the preclinical stage, requiring further validation in human trials.
- Potential risks related to the safety and efficacy of ATR-04 in larger clinical trials.
- No specific timelines provided for the FDA IND application submission and Phase 1b trial initiation.
Insights
The preclinical data on ATR-04 from Azitra, Inc. offers promising evidence for a new treatment of EGFR inhibitor-induced dermal toxicity. This condition affects around 150,000 patients in the US, underscoring a significant unmet medical need. The 99% reduction in methicillin-resistant Staphylococcus aureus (MRSA) on ex vivo pig skin and the substantial decrease in the pro-inflammatory cytokine IL-36γ by 75% highlight ATR-04's potential efficacy.
From a medical perspective, these results are quite compelling as they show both antimicrobial and anti-inflammatory properties, addressing two major aspects of the condition. Additionally, the 18-fold increase in human beta defensin signifies a robust immune response induction, which is critical for treating skin toxicity. While these results are promising, they remain preclinical and thus must be replicated in human trials to fully ascertain their effectiveness and safety. The upcoming IND application and subsequent Phase 1b trials will be important in validating these findings in a clinical setting.
For retail investors, understanding the scientific basis of these results helps gauge the potential market uptake upon successful clinical trials. If ATR-04 progresses past these stages, it could lead to a notable market share in the dermatology therapeutic area, potentially boosting the company's valuation.
Azitra, Inc.’s announcement of positive preclinical data for ATR-04 serves as an important milestone in the company's development pipeline. The target market of 150,000 patients in the US for EGFRi-induced dermal toxicity represents a niche but significant segment. With the demonstrated reduction in MRSA and inflammatory cytokines, ATR-04 seems poised to address critical aspects of this condition, positioning itself uniquely against any current treatments.
From a business perspective, the positive data boosts investor confidence by showcasing progress and potential efficacy. It also strengthens Azitra’s portfolio in the precision dermatology space, potentially attracting partnerships or funding for further development. If the forthcoming IND application and Phase 1b trials replicate these preclinical successes, ATR-04 could command a significant portion of the dermatology therapeutics market, benefiting Azitra's stock performance.
Investors should monitor the upcoming regulatory milestones, as positive outcomes could significantly alter the revenue projections and market position of Azitra. Although preclinical results are promising, they do not guarantee clinical success and investors should be cautious of the inherent risks in drug development.
- ATR-04 is in development for epidermal growth factor receptor inhibitor (EGFRi)-induced dermal toxicity, which affects approximately 150,000 patients in the US
-
Reduces methicillin-resistant S. aureus by
99% on ex vivo pig skin -
Reduces IL-36g, a pro-inflammatory cytokine that drives inflammation in EGFRi-induced toxicity, in human skin model by
75% compared to erlotinib-treated skin - Increases human beta defensin 18-fold vs. vehicle on human skin model
“We are pleased to announce the first publication of preclinical data around ATR-04 in EGFR inhibitor (EGFRi)-associated dermal toxicity,” said Travis Whitfill, Azitra’s co-founder and COO. “These data show robust preclinical activity of ATR-04 in models of EGFRi-induced dermal toxicities that support an upcoming Investigational New Drug (IND) application to the FDA for a Phase 1b in patients undergoing EGFR inhibitors with dermal toxicity. We anticipate the expansion of our clinical-stage pipeline this year with ATR-04.”
ATR-04 is a live biotherapeutic product candidate consisting of an S. epidermidis strain that was isolated from a healthy volunteer and 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 toxicity, 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 data in the oral presentations today showcase the preclinical development of ATR-04. ATR-04 led to a decrease in S. aureus across multiple models. In in vitro skin models, ATR-04 treatment led to a
The presentations are now available on Azitra’s website at https://ir.azitrainc.com/news-events/presentations.
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 advancement of ATR-04 into a Phase 1b clinical trial; expectation that the initial pre-clinical data for ATR-04 will be consistent with the further pre-clinical data; and the benefits of the Company’s proprietary platform and microbial library.
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 (i) the risk that the further data from the ongoing pre-clinical trial for ATR-04 will not be favorably consistent with the initial pre-clinical data to date, (ii) the risk that the Company’s IND application for ATR-04 may not receive a safe to proceed letter from the FDA, (iii) success in early phases of pre-clinical trials do not ensure later clinical trials will be successful; we may fail to timely raise additional required funding; and those 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/20240517627260/en/
Norman Staskey
Chief Financial Officer
staskey@azitrainc.com
Hayden IR
James Carbonara
(646) 755-7412
james@haydenir.com
Source: Azitra, Inc.
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