Azitra, Inc. Expands Eligibility for ATR-04 Phase 1/2 Clinical Trial to Include Patients with Rashes due to KRAS and MEK Inhibitors

Shorter antibiotic and steroid washout periods are expected to facilitate recruitment and accelerate enrollment.

Rhea-AI Summary

Azitra (AZTR) expanded eligibility in its ongoing Phase 1/2 ATR04-484 trial to include patients with KRAS and MEK inhibitor-associated rash. The amendments also include patients with neurofibromatosis type 1 who have MEK inhibitor-associated rash, extending enrollment beyond the trial's initial focus on epidermal growth factor receptor inhibitor-associated rash.

The protocol shortens required washout periods for antibiotics and steroids; Azitra expects the changes to facilitate recruitment and accelerate enrollment. The multicenter, randomized, double-blind, vehicle-controlled study evaluates topical ATR04-484's safety, tolerability, bioavailability, biological effects and preliminary efficacy. Its safety review committee recommended proceeding to Cohort 2 after reviewing available Cohort 1 safety data. Cohort 2 is expected to enroll approximately 24 patients, receiving once-daily treatment for 28 days.

Positive

• Minor pointExpanded trial eligibility includes KRAS and MEK inhibitor-associated rash, including MEK-associated rash in neurofibromatosis type 1 patients.
• Minor point. Forward-looking: it has not happened yet and may not happen.Shorter antibiotic and steroid washout periods are expected to facilitate recruitment and accelerate enrollment.
• Minor pointSafety review committee recommended proceeding to Cohort 2 after reviewing available Cohort 1 safety data.
• Minor point. Forward-looking: it has not happened yet and may not happen.Cohort 2 is expected to enroll approximately 24 patients for once-daily treatment over 28 days.

Negative

• None.

Argus 15 min delay 3 alerts

-4.42% vs previous close $0.86 last price 3.6x rel. volume Open Argus

Details

Market move: AZTR -4.42% vs previous close. Phase 1/2 eligibility expansion

$0.82 – $0.93 Day Range

$5.24M Mkt Cap at Last Price

On Oct 29, the day this news came out, the latest delayed price for AZTR is 4.42% below the previous close. Our momentum scanner has recorded 3 alerts for this stock so far that day. The latest delayed price is $0.86. Relative volume is very high at 3.6x the average.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Gold for real-time data.

Key Figures

Cohort 2 enrollment: approximately 24 patients Treatment duration: 28 days KRAS or MEK inhibitor treatment population: approximately 85,000 patients annually +1 more

Cohort 2 enrollment

approximately 24 patients

Expected enrollment

Treatment duration

28 days

Once-daily Cohort 2 treatment

KRAS or MEK inhibitor treatment population

approximately 85,000 patients annually

United States

EGFR inhibitor treatment population

approximately 220,000 patients annually

United States; existing ATR-04 population

Previous Clinical trial Reports

1 past event · Latest: Oct 01

Same Type 1 event

1. Oct 01

   Cohort 2 clearance

   24h Move

   -6.6%

   Safety committee cleared Cohort 2 after reviewing Cohort 1 data; the trial then focused on EGFR inhibitor-associated rash.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

pharmacodynamics, bioavailability, vehicle-controlled, washout periods, +1 more

5 terms

pharmacodynamics medical

"evaluating the safety, tolerability, bioavailability, pharmacodynamics, and preliminary efficacy"

Pharmacodynamics is how a drug actually affects the body — the strength, type and duration of its effects and the relationship between dose and response. Think of it like how turning a thermostat changes room temperature: it shows what the drug does and how much is needed to get the desired effect. Investors care because these properties drive clinical success, dosing convenience, safety profile and competitive advantage, all of which influence commercial potential and regulatory approval.

bioavailability medical

"evaluating the safety, tolerability, bioavailability, pharmacodynamics, and preliminary efficacy"

Bioavailability is the measure of how much and how quickly a substance, such as a medication or nutrient, enters the bloodstream and becomes available for use by the body. For investors, it matters because it influences how effectively a product works and how quickly results are seen, which can impact a company's success and the potential value of related investments. Think of it like how much of a medicine actually reaches your bloodstream after taking it—that determines how well it can do its job.

vehicle-controlled technical

"multicenter, randomized, double-blind, vehicle-controlled Phase 1/2 study"

A vehicle-controlled study compares a drug or therapy against the same formulation without the active ingredient — the “vehicle” is the inactive carrier or delivery medium. Think of testing a recipe by serving two dishes that look and taste the same except one lacks the key ingredient; any difference shows the ingredient’s real effect. Investors watch vehicle-controlled results because they provide a cleaner measure of a treatment’s benefit and safety, shaping regulatory decisions, clinical value, and company valuation.

washout periods medical

"shorten the required washout periods for antibiotics and steroids"

A washout period is a defined span of time during which certain actions are paused or a previously applied treatment or condition is allowed to dissipate before a subsequent action, measurement, or eligibility begins. In clinical research it means stopping a drug or therapy long enough for its effects to leave the body so a new treatment or a baseline measurement is not confounded; in regulatory, corporate, or securities contexts it can mean a prescribed interval during which transactions or changes are not allowed so earlier arrangements or disclosures can be settled or to avoid overlap. The key feature is that the interval is set to remove carryover effects or legal/administrative overlap; its length depends on the biological, contractual, or regulatory reason for the pause and is defined by protocol, law, or policy rather than by a fixed universal duration.

neurofibromatosis type 1 medical

"patients with neurofibromatosis type 1 (NF1) with rash"

A genetic condition that causes noncancerous tumors to grow on nerves and can lead to skin changes, pain, learning challenges and other complications; severity varies widely from mild to serious. Investors track it because treatments, diagnostics and care pathways for this distinct patient group can drive clinical trial outcomes, regulatory approvals and long‑term revenue, much like a niche market where the size, unmet need and treatment complexity determine potential returns.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

Expanded eligibility significantly broadens potential treatment opportunities for ATR-04 beyond EGFR inhibitor-associated skin rash

Additional protocol modifications expected to facilitate patient recruitment and accelerate clinical trial enrollment

BRANFORD, Conn., Oct. 29, 2026 /PRNewswire/ -- Azitra, Inc. ("Azitra" or the "Company") (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced amendments to its ongoing Phase 1/2 clinical trial of ATR04-484 that significantly expand patient eligibility to include individuals with rash associated with KRAS and MEK inhibitors. The expanded eligibility also includes patients with neurofibromatosis type 1 (NF1) with rash associated with MEK inhibitors. The amendments also shorten the required washout periods for antibiotics and steroids. Together, these changes broaden the potential treatment opportunities for ATR-04 beyond its initial focus on epidermal growth factor receptor inhibitor (EGFRi)-associated skin rash, while expanding the pool of eligible patients to facilitate recruitment.

The multicenter, randomized, double-blind, vehicle-controlled Phase 1/2 study (NCT06830863) is evaluating the safety, tolerability, bioavailability, pharmacodynamics, and preliminary efficacy of topical ATR04-484. The protocol amendments for the Phase 1/2 clinical trial follow Azitra's recent announcement that the study's safety review committee recommended proceeding to Cohort 2 following its review of available safety data from Cohort 1. Cohort 2 is expected to enroll approximately 24 patients who will receive once-daily treatment for 28 days.

KRAS inhibitors and MEK inhibitors are precision therapeutics used to treat various cancers, including non-small cell lung cancer (NSCLC), melanoma, colorectal cancer, and ovarian cancer. Combined, approximately 85,000 patients undergo KRAS or MEK inhibitor treatment in the United States annually. While these therapies have expanded treatment options for patients with cancer, dermatologic adverse effects, including skin rash, can substantially impair quality of life and may require dose reductions, treatment interruptions or discontinuation. The addition of these patients further broadens the potential clinical applications being explored for ATR-04 on top of the approximately 220,000 patients undergoing EGFRi treatment in the United States annually.

The expanded eligibility criteria include patients with NF1 with MEK inhibitor-associated rash. NF1 is a rare genetic disorder characterized by the development of tumors along nerves that affects approximately 100,000 patients in the United States.

"These expansions to the Phase 1/2 trial protocol represent a significant step for our ATR-04 program, increasing the possibility for this innovative treatment to benefit cancer and certain neurofibromatosis patients experiencing debilitating rash due to several targeted therapies," said Francisco Salva, Chief Executive Officer of Azitra. "While these therapies have transformed treatment for many patients, associated skin toxicities can significantly impact quality of life and interfere with treatment. By expanding our study to include patients with rash due to KRAS and MEK inhibitors, we are broadening the potential opportunity for ATR-04. Equally important, we believe the additional protocol modifications will facilitate patient recruitment and help accelerate enrollment. Following our recent advancement to Cohort 2, we are encouraged by the continued progress of this program and its potential to provide a new treatment option for patients affected by debilitating skin conditions."

About Azitra's ATR-04 Program

ATR04-484 is a live biotherapeutic product candidate including an isolated, naturally derived Staphylococcus epidermidis strain in development for skin rashes associated with various therapies for cancer treatment and neurofibromatosis. ATR04-484 was selected based on its preclinical profile of reducing the pro-inflammatory cytokine IL-36γ and Staphylococcus aureus levels, both of which are elevated in patients with cancer treatment-associated skin rash. The strain was then engineered with the aim of improving its safety profile by deleting an antibiotic resistance gene and engineering auxotrophy to control the growth of ATR04. The U.S. Food and Drug Administration (the "FDA") has granted Fast Track designation to ATR04-484 for cancer treatment-associated rash, recognizing the high unmet medical need for up to 300,000 patients affected annually in the United States.

About Azitra, Inc.
Azitra, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology and novel products across therapeutics, cosmeceuticals and biotechnology applications. The Company's portfolio is highlighted by ATR-COSF, a recombinant protein technology designed for cosmetic and skincare applications, and ATR-04, an investigational live biotherapeutic for skin rashes associated with cancer and neurofibromatosis treatments. Azitra has received Fast Track designation from the FDA for cancer treatment-associated rash, which impacts up to 300,000 people in the U.S. Azitra is also advancing additional recombinant protein initiatives designed to support biotechnology research and manufacturing applications. Azitra's technology platforms combine engineered proteins, topical live biotherapeutics, artificial intelligence, and a proprietary microbial library to develop differentiated products for consumer, research and healthcare markets. 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," "would," "target," "continue," "ongoing" 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 (i) the expected enrollment, dosing and conduct of Cohort 2 of the Phase 1/2 clinical trial of ATR-04, (ii) the expected effects of the protocol amendments, including on patient recruitment and enrollment, (iii) the safety and preliminary efficacy data from the trial, (iv) the potential of ATR-04 to treat EGFRi-, KRASi-, MEKi- associated skin rash and other similar rashes, including its potential to be the first live biotherapeutic developed for this indication, (v) the size of the potential patient population and the potential benefits of Fast Track designation, and (vi) statements about our clinical and preclinical programs, and corporate and clinical/preclinical strategies, including our cosmeceutical strategy.

You should not place undue reliance on any forward-looking statements. 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: the timing of clinical trials and their results; we may experience enrollment delays; the protocol amendments may not facilitate recruitment or accelerate enrollment as anticipated; we may experience delays in the provision of initial or additional safety data, as applicable, and topline results for ATR-04 and, if we do, such data and results may not be favorably received; the expanded patient populations may present different safety or efficacy profiles; the results from Cohort 1 may not be predictive of results in Cohort 2 or later-stage trials; the safety and efficacy of our product candidates; possible 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 or incorporated by reference in our annual report on Form 10-K filed with the United States Securities and Exchange Commission (the "SEC") on February 27, 2026 and our quarterly report on Form 10-Q filed on August 12, 2026 with the SEC. Azitra explicitly disclaims any obligation to update any forward-looking statements to reflect events or circumstances that occur after the date hereof, except to the extent required by law.

Contact
Norman Staskey
Chief Financial Officer
staskey@azitrainc.com

Investor Relations 
Tiberend Strategic Advisors, Inc.
David Irish
231-632-0002
dirish@tiberend.com

Media Relations
Tiberend Strategic Advisors, Inc.
Casey McDonald
646-577-8520
cmcdonald@tiberend.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/azitra-inc-expands-eligibility-for-atr-04-phase-12-clinical-trial-to-include-patients-with-rashes-due-to-kras-and-mek-inhibitors-302922983.html

SOURCE Azitra, Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

Which patients are now eligible for Azitra's ATR-04 Phase 1/2 trial?

The expanded eligibility includes patients with KRAS or MEK inhibitor-associated rash, including patients with neurofibromatosis type 1 who have MEK inhibitor-associated rash. This broadens eligibility beyond the initial focus on epidermal growth factor receptor inhibitor-associated skin rash.

What is planned for Cohort 2 of Azitra's ATR04-484 trial?

Cohort 2 is expected to enroll approximately 24 patients who will receive once-daily treatment for 28 days. The safety review committee recommended proceeding after reviewing available safety data from Cohort 1.