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2025年7月和8月,Liquidia分析了为期52周的前瞻性、开放标签ASCENT研究的中期数据,该研究全面招募了54名患有间质性肺病(PH-ILD)相关肺动脉高压的患者
2025-08-12 18:36
- Safety data and observed exploratory efficacy data was summarized for Week 8 and Week 16 timepoints.
- The tolerability profile of YUTREPIA in PH-ILD was consistent with initial observations in the first 20 patients at Week 8. Most patients continued on treatment to Week 16 with 10 of 54 (18.5%) discontinuing the study.
- There were no discontinuations stemming from drug-related adverse events, such as cough or throat irritation. Of those patients who reported a treatment related cough, 24 of 26 patients reported a mild cough and 2 patients reported a moderate cough.
- The mean daytime simplified cough scores remained essentially unchanged from baseline through Week 16, suggesting the cough tended to be transient nature. Dose titration remains steady, with a median dose of 132.5 mcg QID at Week 8, and 159 mcg QID at Week 16.
- The highest exposure at Week 16 was 318 mcg QID. The median improvements in six-minute walk distance were 21.5 meters at Week 8 and 31.5 meters at Week 16.
- Release of detailed clinical data is targeted for medical conferences in September and October of 2025.
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