Azitra Receives Study May Proceed letter from the FDA for IND to Treat Skin Rash from EGFR Inhibitors

Rhea-AI Summary

Azitra (NYSE American: AZTR) has received FDA clearance for an IND application to conduct a Phase 1/2 clinical study of ATR-04, targeting moderate to severe EGFR inhibitor-associated dermal toxicity. This condition affects an estimated 150,000 patients in the US, representing a global market size exceeding $1 billion. ATR-04, a live biotherapeutic product, has shown promise in preclinical studies by reducing IL-36γ and Staphylococcus aureus, key factors in EGFRi-associated skin rash. The company plans to initiate a multicenter, randomized, controlled trial by the end of 2024. This development expands Azitra's clinical pipeline, addressing a significant unmet need for cancer patients receiving EGFR inhibitors who often experience severe skin side effects.

Positive

• FDA clearance received for IND application to conduct Phase 1/2 clinical study of ATR-04
• Targeting a global market size exceeding $1 billion
• Preclinical data shows ATR-04 reduces key drivers of EGFRi-associated skin rash
• Expansion of Azitra's clinical pipeline addressing an unmet medical need

Negative

• Clinical trial initiation planned for end of 2024, indicating a long timeline before potential revenue generation
• No approved therapies currently exist for this condition, suggesting potential regulatory challenges

Insights

Medical Research Analyst

The FDA's clearance of Azitra's IND application for ATR-04 is a significant milestone in addressing EGFR inhibitor-associated skin rash, a common side effect in cancer patients. This development is particularly noteworthy due to the lack of approved therapies for this condition, which affects an estimated 150,000 patients in the US alone.

The potential market size of over $1 billion globally underscores the commercial importance of this therapy. ATR-04's unique mechanism, targeting both IL-36γ and Staphylococcus aureus, addresses key drivers of the condition. The planned Phase 1/2 clinical trial by the end of 2024 will be important in determining the therapy's efficacy and safety in humans.

While promising, investors should note that drug development is a lengthy process with inherent risks. The success of ATR-04 could significantly impact Azitra's market position in precision dermatology, but it's essential to monitor the upcoming clinical trial results closely.

Oncology Doctor

The development of ATR-04 for EGFR inhibitor-associated dermal toxicity addresses a critical unmet need in cancer care. As an oncologist, I've seen firsthand how these skin rashes can significantly impact patients' quality of life and even lead to the discontinuation of important cancer treatments.

The engineered Staphylococcus epidermidis strain in ATR-04 is an innovative approach, potentially offering a safer alternative to current management strategies. The deletion of the antibiotic resistance gene and engineered auxotrophy are clever safety measures that could minimize risks associated with live biotherapeutics.

If successful, ATR-04 could be a game-changer in maintaining continuity of cancer treatment for patients on EGFR inhibitors. However, it's important to await the results of the upcoming clinical trials to assess its efficacy and safety profile in actual patients.

Financial Analyst

Azitra's IND clearance for ATR-04 represents a significant potential revenue stream for the company. With an estimated market size exceeding $1 billion globally, this therapy could substantially impact Azitra's financial outlook if successfully developed and commercialized.

Investors should note that Azitra (NYSE American: AZTR) is positioning itself in a niche but potentially lucrative market. The lack of approved therapies for EGFR inhibitor-associated skin rash presents a first-mover advantage opportunity. However, it's important to consider the long timeline and high costs associated with drug development.

While the news is positive, financial prudence suggests waiting for Phase 1/2 clinical trial results before making significant investment decisions. The success of ATR-04 could be a major catalyst for Azitra's stock, but investors should also be prepared for the inherent risks in biopharmaceutical development.

• 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.

BRANFORD, Conn.--(BUSINESS WIRE)-- 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240822068011/en/

Company Contact

Norman Staskey

Chief Financial Officer

staskey@azitra.com

Hayden IR

James Carbonara

(646)-755-7412

james@haydenir.com

Source: Azitra, Inc.

FAQ

What is ATR-04 and what condition does it target for Azitra (AZTR)?

ATR-04 is a live biotherapeutic product developed by Azitra (AZTR) to treat moderate to severe EGFR inhibitor-associated dermal toxicity, a skin rash that affects cancer patients receiving EGFR inhibitors.

What is the market potential for Azitra's (AZTR) ATR-04?

The market potential for Azitra's (AZTR) ATR-04 exceeds $1 billion globally, with an estimated 150,000 patients suffering from EGFRi-induced skin toxicity in the United States alone.

When does Azitra (AZTR) plan to start clinical trials for ATR-04?

Azitra (AZTR) plans to initiate a multicenter, randomized, controlled Phase 1/2 clinical trial of ATR-04 by the end of 2024.

What did preclinical studies show about Azitra's (AZTR) ATR-04?

Preclinical studies of Azitra's (AZTR) ATR-04 showed significant reductions in IL-36γ and methicillin-resistant S. aureus (MRSA) in preclinical models, which are key drivers of EGFRi-associated skin rash.