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Also known as ATR-12
ATR12-351 · 1 trial · 1 indication
Incidence, severity, seriousness and relatedness of all treatment-emergent adverse events
| Arm | Type | Description |
|---|---|---|
| Internal controlled arm | EXPERIMENTAL | ATR12-351 on left side of body, vehicle on right side of body in one group; vehicle on left side of body, ATR12-351 on right side of body. |
| Name | Type | Description |
|---|---|---|
| ATR12-351 | DRUG | Topical ointment containing ATR12-351, a LEKTI-secreting strain of S. epidermidis |
Inclusion Criteria: * Adults ≥18 years of age * Confirmed mutation of the serine protease inhibitor of Kazal type 5 (SPINK5) gene * Involvement of ≥20% of body surface area with skin changes consistent with Netherton syndrome Exclusion Criteria: * Use of biologic therapies, antibiotics, antihista...
ATR12-351 is an investigational topical small molecule being developed for the treatment of Netherton Syndrome, a rare genetic skin disorder. It is not yet approved for any indication and remains in clinical development. Azitra Inc is evaluating it as a topical therapy for adults with this condition.
ATR12-351 targets LEKTI, a protein encoded by the SPINK5 gene that is deficient in Netherton Syndrome. By targeting this protein, the therapy aims to address the underlying cause of the skin barrier defect associated with the condition. LEKTI deficiency leads to uncontrolled protease activity in the skin.
ATR12-351 is being developed by Azitra Inc, a clinical-stage biopharmaceutical company. Azitra trades on the NYSE American under the ticker symbol AZTR. The company focuses on developing therapies for rare skin diseases, and ATR12-351 is its topical small molecule candidate for Netherton Syndrome.
ATR12-351 is in Phase 1 clinical development. A single Phase 1 trial has been completed, evaluating the topical therapy in adults with Netherton Syndrome. The drug is investigational and has not received FDA approval for any indication.
ATR12-351 has been studied in one completed Phase 1 trial, NCT06137157, titled Evaluation of Topical ATR12-351 in Adults With Netherton Syndrome. The trial enrolled 6 participants in the United States, was uncontrolled, and included adults aged 18 years and older of all sexes.