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C21 is a small molecule compound, which is in clinical development for the treatment of IPF and COVID-19. The experimental programme will assess the potential of C21 for addressing fibrosis, inflammation and vasculopathy in a variety of diseases such as IPF.
The AIR trial1 is an open label single arm phase 2 trial in treatment naïve IPF patients in which 100 mg of C21 (VP01) was administered twice daily for 24 weeks with an optional 12-week extension.
With these results, the company initiates the planning of AIR 2, a double-blind controlled phase 2 dose-finding study to confirm these results and accelerate the development of C21 in parallel to completing the AIR trial.
The study is a phase II, multi-center, open-label, single-arm trial investigating the safety, effect on lung function and pharmacokinetics of C21 in 60 subjects with IPF.
Fresh human IPF lung tissue harvested from a patient during lung transplantation showed stable expression of the VP01 target, AT2R, and treatment with clinically relevant concentrations of VP01 caused a dose-dependent decrease of TGFb1.