Vicore Pharma has announced data from an interim analysis suggesting that C21 stabilizes disease and increases lung function in idiopathic pulmonary fibrosis (IPF) patients as quantified by standard FVC (Forced Vital Capacity) measurement.
An interim analysis of the phase 2 proof-of-concept study in IPF (the AIR1study) showed an initial stabilization of disease and then an increase in FVC up to the end of the study at 36 weeks. At the time of the interim analysis, there were 21 evaluable patients of which 13, 9 and 7 patients reached 12, 24 and 36 weeks of treatment, respectively. After 24 weeks, the increase in mean FVC was +251 ml, a considerable difference of 371 ml compared to the expected decline of 120 ml in 24 weeks in an untreated population. Five of the seven patients who completed both 24 and 36 weeks of C21 treatment showed continued improvement in FVC and two remained stable. Analysis of FVC slope values at 28, 32 and 36 weeks are statistically significant (p=0.016 at 36 weeks) compared to the expected mean for untreated patients. The study drug was well tolerated with no related serious adverse events, acute exacerbations, or gastrointestinal signals.
The AIR study
The AIR study is an open label single arm study in treatment naïve IPF patients in which 100 mg of C21 was administered twice daily for 24 weeks with an optional 12-week extension. The study is being conducted in the UK, India, Ukraine, and Russia. A correct diagnosis was secured by central reading of high-resolution computer tomography (HRCT). To assess lung volume, the gold standard for FVC measurements, the ERT system, was used at all sites.
The next stage
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.
“Now that the interim analysis has shown both safety and a positive effect on lung function in this trial, we want to move as quickly as possible to the next stage to be able to bring this treatment to patients,” says Rohit Batta, Chief Medical Officer of Vicore.
Photo of Rohit Batta: Vicore