Vicore Pharma Holding AB (publ) (“Vicore”), a clinical-stage pharmaceutical company developing medicines targeting the angiotensin II type 2 receptor (AT2R), today announces that the previously published interim data from AIR, a phase 2 trial in IPF), will be presented as an oral “late-breaker” on September 4 at 15:00 CET during the European Respiratory Society (ERS) congress in Barcelona, Spain.
The AIR trial1 is an open label single arm phase 2 trial 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 trial is being conducted in the UK, India, Ukraine and Russia. The IPF diagnosis was established through central reading of high-resolution computer tomography (HRCT). To assess lung function, the gold standard for FVC* measurements was used at all sites. Earlier this year, the company reported promising interim data with increases in lung capacity after 24 to 36 weeks treatment with C21.
The interim data showed that at 24 weeks, the mean FVC was +251 ml (n=9) over baseline versus the expected -120 ml reduction in an untreated population (a difference of 370 ml). At 36 weeks, 5 out of the 7 patients further increased their lung capacity, and 2 remained stable. C21 was safe and well tolerated. The phase 2 trial continues to enroll patients, and in parallel, the company is preparing for the next trial in close collaboration with regulatory and scientific experts.
“The magnitude of the impact on FVC seen in this interim analysis is truly interesting with an increase in lung function over time and if it holds through in a controlled trial, C21 will create a paradigm shift in IPF.” says presenter Professor Toby Maher, the Keck School of Medicine at the University of Southern California