Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ATR04-484 · 1 trial · 1 indication
Treatment-emergent adverse events
| Arm | Type | Description |
|---|---|---|
| ATR04-484 | EXPERIMENTAL | Topically applied ATR04-484 |
| Vehicle | PLACEBO_COMPARATOR | Topically applied vehicle |
| Name | Type | Description |
|---|---|---|
| ATR04-484 | DRUG | ATR04-484 is a recombinant live biotherapeutic product (rLBP) containing the engineered S. epidermidis strain SE484 in an ointment formulation for topical use |
| Vehicle | DRUG | Topically applied vehicle. |
Inclusion Criteria: * Adults ≥18 years of age * Has Grade 2 or 3 non-infected moderate to severe EGFRi-related dermal toxicity affecting the face (the neck, chest, back and other areas may also be affected) Exclusion Criteria: * Significant skin disease other than EGFRi-related dermal toxicity * ...
ATR04-484 is an investigational small molecule being developed for the treatment of EGFR inhibitor-associated rash, a dermatologic condition. It is a topical therapy designed to address dermal toxicity that can occur in patients receiving EGFR inhibitor treatments. The drug is currently being evaluated in a Phase 1 clinical trial.
ATR04-484 targets EGFR, the epidermal growth factor receptor, a protein involved in cell signaling and growth. By targeting EGFR, the drug is intended to address skin-related side effects associated with EGFR inhibitor therapy. This mechanism is the basis for its potential use in managing EGFR inhibitor-associated rash.
ATR04-484 is being developed by Azitra Inc, a biopharmaceutical company. Azitra is conducting clinical research on this investigational therapy for EGFR inhibitor-associated rash. The company is listed on the stock exchange under the ticker symbol AZTR.
ATR04-484 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 1 trial is actively recruiting participants to evaluate the therapy's safety and tolerability in patients with EGFR inhibitor-associated rash.
ATR04-484 is being studied in a Phase 1 clinical trial registered as NCT06830863. This trial is titled 'A Study to Evaluate Topical ATR04-484 for EGFRi-Associated Dermal Toxicity' and is currently recruiting participants in the United States. The study is randomized, double-blind, and placebo-controlled, with an enrollment target of 32 patients.
ATR04-484 is a distinct investigational small molecule that targets EGFR, but it is being developed specifically for the dermatologic side effect of EGFR inhibitor-associated rash. It is not described as being the same as any other named drug. Its unique formulation and indication differentiate it from other EGFR-targeting therapies.