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Excellent results for C21 in idiopathic pulmonary fibrosis

Presented by
Prof. Toby Maher , Keck School of Medicine of USC, USA
ATS 2023
Phase 2, AIR
Patients with idiopathic pulmonary fibrosis (IPF) who were treated with the angiotensin type 2 receptor agonist C21 showed disease stabilisation over the 36-week study period of the phase 2a AIR trial. Together with the good tolerability of this agent and positive patient testimonials, the authors concluded that the results strongly support further investigation of C21 in a phase 2b study. 

The AIR (NCT00214526) trial assessed the safety and efficacy of C21 in 60 patients with IPF [1]. Prof. Toby Maher (Keck School of Medicine, University of Southern California, CA, USA), who presented the data of the current interim analysis, emphasised that the baseline characteristics of the included patients were in line with other trials that included either treatment-naïve patients or patients that were not treated with the standard-of-care.  

At 36 weeks, C21 displayed a significant positive impact on forced vital capacity compared with baseline (P<0.001). Prof. Maher added that C21 was still efficacious if a ‘worst-case-scenario’ was wielded for the missing data (P<0.01). Importantly, C21 appeared to be a safe and tolerable agent. “There were no serious gastro-intestinal side effects,” commented Prof. Maher. “The only adverse event that occurred in >10% of the patients was hair loss, more frequently seen in the higher dose groups.” He added that, compared with nintedanib, the safety profile of C21 looks promising. 

Prof. Maher concluded that the results of the AIR trial indicate that treatment with C21 is safe and may lead to disease stabilisation in patients with IPF. 

  1. Batta R, et al. An updated interim analysis of the Air trial: an open-label single-arm 36 week phase 2 trial of an angiotensin type 2 receptor agonist, C21, in individuals with IPF. Session A99, ATS International Conference 2023, 19–24 May, Washington DC, USA. 


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