Patients with idiopathic pulmonary fibrosis (IPF) treated with C21 showed disease stabilization over the 36-week study period of the phase 2a AIR trial.
The AIR (NCT00214526) trial assessed the safety and efficacy of the angiotensin type 2 receptor agonist C21 in 60 patients with IPF. Rohit Batta, MD, who presented the data of the current interim analysis at the 2023 American Thoracic Society (ATS) International Conference, held May 19-24, in Washington, DC, emphasized that the baseline characteristics of the study patients were in line with other trials that included either treatment-naïve patients or patients who 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). Dr. Batta 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 safe and tolerable. “There were no serious gastrointestinal side effects,” commented Dr. Batta. “The only adverse event that occurred in more than 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.
The results of the AIR trial indicate that treatment with C21 is safe and may lead to disease stabilization in patients with IPF, Dr. Batta concluded. Together with the good tolerability of C21 and positive patient testimonials, the investigators concluded that the results strongly support further investigation of C21 in a phase 2b study.
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