ATR-04 / Azitra - LARVOL DELTA

A Study to Evaluate Topical ATR04-484 for EGFRi-Associated Dermal Toxicity (clinicaltrials.gov) - P1/2 | N=32 | Recruiting | Sponsor: Azitra Inc. | Trial completion date: May 2026 ➔ Feb 2027 | Trial primary completion date: Mar 2026 ➔ Jan 2027

Trial completion date • Trial primary completion date

Study to Evaluate the Safety of ATR-04 (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Azitra Inc. | Phase classification: P1b/2a ➔ P1/2 | N=60 ➔ 0 | Suspended ➔ Withdrawn

Enrollment change • Phase classification • Trial withdrawal • Dermatology • Rosacea

Epidermal growth factor receptor (EGFR) inhibitor-induced dermal toxicity treated with topical application of a novel Staphylococcus epidermidis compound. (ASCO 2025) - "IL-36γ levels were measured on RHE treated with erlotinib alone or in combination with ATR04-484. The bioavailability of ATR04-484 and pharmacodynamic parameters (including IL-36γ) are also studied. This clinical study will establish the basis for continued clinical development of ATR04-484."

Colorectal Cancer • Dermatology • Head and Neck Cancer • Infectious Disease • Oncology • Pain • Pruritus • Solid Tumor

A Novel Staphylococcus epidermidis Compound for the Topical Treatment Epidermal Growth Factor Receptor (EGFR) Inhibitor-Induced Dermal Toxicity (ASGCT 2025) - "IL-36g levels were measured on RHE treated with erlotinib alone or in combination with ATR04-484. This clinical study will establish the basis for continued clinical development of ATR04-484. Disease Focus of Abstract:Inflammatory Disorders"

Dermatology • Infectious Disease • Oncology • Pain • Pancreatic Cancer • Pruritus

A Study to Evaluate Topical ATR04-484 for EGFRi-Associated Dermal Toxicity (clinicaltrials.gov) - P1/2 | N=32 | Recruiting | Sponsor: Azitra Inc. | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2025 ➔ Jun 2025

Enrollment open • Trial initiation date

Azitra, Inc. to Present ATR-04 Program Update at ASCO 2025 (PRNewswire) - "Azitra, Inc...announced that an abstract detailing the Phase 1/2 clinical trial of ATR04-484 in EGFR inhibitor ('EGFRi')-associated rash has been accepted for presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting being held May 30-June 3, 2025 in Chicago....'We look forward to presenting an update on the ATR-04 program at ASCO as we plan to dose the first patient in the first half of 2025.'"

Trial status • Dermatology

Azitra, Inc. Announces Full Year 2024 Financial Results and Provides Business Updates (PRNewswire) - "Initiated a Phase 1b clinical trial investigating ATR-12 in adult Netherton syndrome patients; Initial safety data from first set of Netherton syndrome patients expected in the first half of 2025 with topline data from the Phase 1b trial by year-end 2025...'Our next milestone in the development of ATR-04 is the first patient dosed in a multicenter, randomized, controlled Phase 1/2 clinical trial in patients undergoing EGFR inhibitors with dermal toxicity, which we expect to occur in the first half of 2025.'"

New P1/2 trial • P1 data • Dermatology • Metabolic Disorders