A new interim analysis of data from the ongoing phase 2 AIR trial on the safety and efficacy of C21 in patients with idiopathic pulmonary fibrosis (IPF) reflects stabilization of lung capacity at week 6 and an increase in forced vital capacity (FVC) from weeks 18 to 36.
The results were presented in a conference call on Friday, November 4.
“The new results from the AIR trial show even greater patient benefit than in the first interim analysis. To be able to stop disease progression with a safe and well tolerated drug would be a major step forward in the treatment of IPF and if the increase in FVC holds true in future trials, it would suggest that C21 has disease modifying effects” says Carl-Johan Dalsgaard, CEO of Vicore.
C21 is an angiotensin AT2 receptor agonist. It has been shown to stimulate resolution and repair in the progenitor cells that maintain alveolar integrity in acute and chronic lung conditions such as IPF. In the AIR trial, 12 weeks of C21 treatment twice orally as monotherapy resulted in an increase of 28 mL from baseline in FVC, while in untreated patients, a decline in FVC of approximately 80 and 120 mL is typically observed at 12 and 24 weeks, respectively.
Read more about IPF experimental therapies
After 6 months of treatment with C21, an increase in FVC of 213 mL was observed, and after 9 months, the increase was 633 mL compared with baseline measurements. Based on the highly encouraging data, Vicore has established a global advisory committee to design and execute the next IPF study to employ C21.
The phase 2a AIR trial recruited its first patient in November, 2020 and is ongoing in multiple centers in the UK, India, Ukraine and Russia, although the trial has been paused in Ukraine and Russia because of the conflict.
Laurent Pharmaceuticals presents results from phase 2 clinical study of LAU-7b in cystic fibrosis at the NACFC 2022. News release. Laurent Pharmaceuticals; November 3, 2022.