相关临床试验
4
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
已完成
2
50.0%
招募中
1
25.0%
撤回
1
25.0%
暂无批准数据
- Azitra has dosed the first patient in its Phase 1/2 clinical trial of ATR04-484, a topically applied live biotherapeutic designed to treat EGFR inhibitor-associated rash affecting approximately 150,000 people annually in the U.S. - The multicenter, randomized, double-blind study will evaluate the safety and tolerability of the engineered Staphylococcus epidermidis strain, which was selected for its ability to reduce IL-36γ and S. aureus levels elevated in EGFRi-associated skin rash. - EGFR inhibitor-associated papulopustular rash occurs in 50-80% of patients receiving these targeted cancer therapies and can severely impact quality of life, often leading to treatment interruption or discontinuation. - The FDA has granted Fast Track designation for ATR04-484, highlighting the critical unmet medical need for managing dermatologic toxicities that accompany EGFRi treatments across multiple cancer types including NSCLC and colorectal cancer.
- Azitra has initiated a Phase 1b trial for ATR-12 in Netherton syndrome patients, with initial safety data expected in H1 2025 and topline results by year-end 2025. - The company received FDA clearance and Fast Track designation for ATR-04, targeting EGFR inhibitor-associated skin rash, with Phase 1/2 trial initiation planned for first half of 2025. - Preclinical data showed ATR-12 significantly reduced protease activity in Netherton syndrome skin samples, while ATR-04 demonstrated inhibition of key disease drivers IL-36g and S. aureus.
- Azitra dosed the first patient in its Phase 1b trial of ATR-12 for Netherton syndrome, a genetic skin disorder, marking a key milestone in the drug's development. - The FDA granted Fast Track designation to ATR-04 for EGFR inhibitor-associated rash, expediting its development and review process. - A Phase 1/2 clinical study of ATR-04 for EGFRi rash is set to begin in early 2025, following IND clearance from the FDA. - Azitra reported $10 million in gross proceeds from a follow-on offering, strengthening its financial position to advance its clinical programs.
- Azitra's ATR-04, a topical therapy for moderate to severe skin rash induced by EGFR inhibitors, has received FDA Fast Track designation. - The Fast Track program aims to expedite the development and review of drugs addressing serious conditions with unmet medical needs, potentially accelerating ATR-04's approval. - ATR-04 is a live biotherapeutic product with a modified Staphylococcus epidermidis strain, designed to enhance safety and address skin immunity suppression. - Azitra plans to initiate a Phase I/II clinical trial by the end of 2024 to evaluate ATR-04's efficacy and safety in treating EGFR inhibitor-induced dermal toxicity.
