Here, we outline the design of a Phase 2 rollover study (Clairleaf) assessing long-term safety and efficacy of BI 1291583.Methods: Clairleaf will include ~220 patients who have completed the parent trials Airleaf or Clairafly. Part A of Clairleaf is a randomised, double-blind study ...
First evidence comes from the CatC inhibitor brensocatib (formerly AZD7986), which is currently in Phase 3 development for bronchiectasis (NCT04594369) [29]. BI 1291583 is a novel, highly potent and selective CatC inhibitor under investigation as a potential disease-modifying therapy for patients ...
HSK31858 is a CatC inhibitor that is currently being assessed in a Phase 2 clinical trial in patients with non-CF bronchiectasis (NCT05601778). Brensocatib (formerly AZD7986) is an Fig. 5 PR3 activity in mouse BALF neutrophil lysate after treat- ment with BI 1291583 and subsequent...
Novel cathepsin C inhibitor, BI 1291583, intended for treatment of bronchiectasis: Phase I characterization in healthy volunteers Here, we present the phase I characterization of the novel CatC inhibitor, BI 1291583. Five phase I trials of BI 1291583 in healthy subjects are ... P Badorrek,C ...
Additionally, BI 1291583 inhibited CatC in a dose‐dependent manner, inhibited downstream NE activity, and decreased PR3 levels. No food effect was observed. Co‐administration of multiple doses of itraconazole increased BI 1291583 exposure approximately twofold. Due to these promising phase I results...
The preclinical and phase 1 development of the novel oral cathepsin C inhibitor BI 1291583 Preclinical and phase 1 study results indicate that BI 1291583 is a reversible, highly potent and highly selective CatC inhibitor that markedly inhibits ac... James D Chalmers,Philipp Badorrek,Claudia Diefenb...
Preclinical and phase 1 study results indicate that BI 1291583 is a reversible, highly potent and highly selective CatC inhibitor that markedly inhibits active NSP production in a dose-dependent manner, supporting phase 2 trials in bronchiectasis patients https://bit.ly/47PZ8E5.James D Chalmers...
Additionally, BI 1291583 inhibited CatC in a dose‐dependent manner, inhibited downstream NE activity, and decreased PR3 levels. No food effect was observed. Co‐administration of multiple doses of itraconazole increased BI 1291583 exposure approximately twofold. Due to these promising phase I ...
Results: Overall, 36 subjects (n = 24 for SRD part; n = 12 for MD part) entered this Phase I trial. BI 1291583 was safe and well tolerated across the doses tested. All AEs were of mild intensity, with no drug‐related treatment‐emergent AEs, deaths, serious AEs or AEs of special...