#United States #Chicago #Azitra #Biomarker #EGFRi

Azitra, Inc. to Present Innovative Clinical Trial at ASCO 2025

Azitra, Inc. (NYSE American: AZTR), a biopharmaceutical company focused on precision dermatology, will present intriguing findings from its Phase 1/2 clinical trial of the novel therapeutic ATR04-484 aimed at treating EGFR inhibitor (EGFRi)-associated rash. This presentation is scheduled to take place during the 2025 American Society of Clinical Oncology Annual Meeting (ASCO 2025) in Chicago, from May 30 to June 3, 2025.

Overview of the ATR04-484 Clinical Trial

The pivotal study titled "Epidermal growth factor receptor (EGFR) inhibitor-induced dermal toxicity treated with topical application of a novel Staphylococcus epidermidis compound" dives into the safety and tolerability of ATR04-484. This Phase 1/2 trial comprises a multicenter, randomized, double-blind, vehicle-controlled design, and it particularly targets adult patients who experience dermal toxicity stemming from EGFR inhibitors.

The compound, ATR04-484, is developed from a live biotherapeutic product candidate, which incorporates a specially isolated strain of Staphylococcus epidermidis. This strain was carefully engineered to be both safe and effective—specifically, it excludes an antibiotic resistance gene and is modified to regulate its growth selectively.

Importance of the Drug

EGFR inhibitors play a crucial role in treating various cancers, such as non-small cell lung cancer (NSCLC) and colorectal cancer, by obstructing the action of the epidermal growth factor receptor (EGFR) protein, which is vital for cell proliferation and survival. Despite their effectiveness, these inhibitors can lead to severe dermatologic side effects, severely affecting patients’ quality of life and often leading them to reduce or discontinue treatment.

Mary Spellman, MD, Chief Medical Officer of Azitra, stresses the significant potential of ATR04-484 in improving patient outcomes: “We believe topical ATR04-484 has the potential to be an important advance in the treatment of EGFRi-associated skin rash, which is a painful and debilitating condition that often leads patients to suspend use of these life-saving cancer therapies.”

Presentation Details

The specific details of the upcoming presentation include:

• - Event: 2025 American Society of Clinical Oncology Annual Meeting
• - Location: McCormick Place, Chicago, IL
• - Track: Symptom Science and Palliative Care
• - Poster Title: Epidermal growth factor receptor (EGFR) inhibitor-induced dermal toxicity treated with topical application of a novel Staphylococcus epidermidis compound
• - Presenter: Mary Spellman, MD
• - Poster Number: 162b

Company Profile

Azitra, Inc. is at the forefront of innovation in the biopharmaceutical realm as it focuses on treatments aimed at precision dermatology. Its lead program, ATR-12, utilizes a tailored strain of S. epidermidis designed to treat Netherton syndrome, which remains a challenge due to the lack of approved treatment. This condition can pose fatal risks in infancy and present serious long-term challenges.

ATR-04, targeting EGFRi-associated rashes, aligns with Azitra's mission to address significant healthcare gaps affecting thousands— in fact, the FDA has granted Fast Track designation for its treatment of EGFRi-associated rash, which affects around 150,000 individuals in the U.S. alone. The ATR-12 and ATR-04 initiatives are built on Azitra's proprietary platform of engineered live biotherapeutic products, which leverage AI and machine learning technologies to enhance treatment efficacy.

Conclusion

As Azitra prepares to showcase these pivotal findings at ASCO 2025, the potential impact of ATR04-484 on enhancing the lives of patients suffering from the side effects of cancer treatments is monumental. With promising research and a commitment to innovation, Azitra, Inc. is poised to play a crucial role in the future of cancer therapy and patient care. Stay tuned as we witness the outcomes and future directives following this landmark presentation.