Azitra Receives Study May Proceed Letter From The FDA For IND To Treat Skin Rash From EGFR Inhibitors
Azitra Receives Study May Proceed Letter From The FDA For IND To Treat Skin Rash From EGFR Inhibitors
Azitra收到FDA关于IND前行研究的批准信，用于治疗EGFR抑制剂引起的皮疹。
- New investigational new drug (IND) application cleared to proceed by the US FDA for a Phase 1/2 clinical study of ATR-04 for moderate to severe EGFR inhibitor ("EGFRi") associated dermal toxicity.
- There are an estimated 150,000 patients with EGFRi-associated skin rash in the US, representing a >$1 billion global market size.
- Preclinical data show ATR-04 reduces IL-36γ and Staphylococcus aureus, key drivers of EGFRi-associated skin rash.
- 美国FDA已批准ATR-04用于中度至重度EGFR抑制剂相关皮肤毒性的一期/二期临床研究的新的临床试验(IND)申请获准继续进行。
- 据估计，美国有大约15万名EGFR抑制剂相关皮疹患者，全球市场规模超过10亿美元。
- 临床前数据显示ATR-04能够减少EGFR抑制剂相关皮疹的关键驱动因子IL-36γ和金黄色葡萄球菌。
Azitra, Inc. (NYSE:AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced the clearance of an investigational new drug (IND) application to U.S. Food and Drug Administration (FDA) for a first-in-human Phase 1/2 clinical study of ATR-04 for moderate to severe EGFRi associated dermal toxicity.
纽交所上市的Azitra，Inc. (NYSE:AZTR)是一家临床阶段的生物制药公司，致力于开发创新的精准皮肤病疗法，今天宣布已获得美国食品和药物管理局(FDA)批准进行一项关于ATR-04用于中度至重度EGFR抑制剂相关皮肤毒性的首次人体一期/二期临床研究的临床前研究新药(IND)申请。