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關於IND前行研究的批准信，用於治療EGFR抑制劑引起的皮疹。
- 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.
- 美國FDA已批准ATR-04用於中度至重度EGFR抑制劑相關皮膚毒性的一期/二期臨床研究的新的臨床試驗(IND)申請獲准繼續進行。
- 據估計，美國有大約15萬名EGFR抑制劑相關皮疹患者，全球市場規模超過10億美元。
- 臨床前數據顯示ATR-04能夠減少EGFR抑制劑相關皮疹的關鍵驅動因子IL-36γ和金黃色葡萄球菌。
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.
紐交所上市的Azitra，Inc. (NYSE:AZTR)是一家臨床階段的生物製藥公司，致力於開發創新的精準皮膚病療法，今天宣佈已獲得美國食品和藥物管理局(FDA)批准進行一項關於ATR-04用於中度至重度EGFR抑制劑相關皮膚毒性的首次人體一期/二期臨床研究的臨床前研究新藥(IND)申請。