New Phase IIa data indicates that Vicore Pharma’s C21 has the potential to transform the treatment of idiopathic pulmonary fibrosis (IPF) and restore lung function.
In data from the AIR trial, C21 has demonstrated long-term efficacy. At 36 weeks, the average forced vital capacity (FVC) had increased to +350ml over baseline, which is +530ml over the expected trajectory of untreated patients.
Professor Toby Maher, Keck School of Medicine at University of Southern California, commented: “The magnitude of FVC stabilisation seen with C21 in the AIR trial is very different from what we normally see in clinical practice and certainly gives hope for patients. If data are replicated in the ANDAS trial, there will be a fundamental change in how IPF is treated with an opportunity to stop progression and restore lung function”.
The new dataset shows a stabilisation of lung capacity at week six and, in line with previous interim analysis, a subsequent increase of FVC from week 16 to 36.
Carl-Johan Dalsgaard, CEO of Vicore, said: “The long-term stabilisation and increase in FVC is unique for patients treated with C21 and consistent with the mechanism of action of an ATRAG. Restoring alveolar integrity is key in treating IPF and that is what C21 is doing”.
Recruitment to the AIR trial will be concluded to fully focus on the next step of development, the Phase IIb ANDAS trial.