Vicore submits clinical trial application for phase II trial with C21 in IPF
The phase II clinical study in patients with IPF will be a six months single arm open label study which will compare the effect of C21 to the well documented linear decline of lung function in untreated patients. It will also be possible to, on an individual basis, extend the trial period for an additional three months, up to a total of nine months, allowing further collection of meaningful data.
As previously communicated, the updated study design, provides stronger statistical power to detect a treatment effect. This is feasible since the validated endpoint, FVC (forced vital capacity), a measurement of lung volume, is an objective and consistent measure of disease progression which decreases with approximately 120 ml per six months.
“The extension from three to six months has a dramatic effect on the statistical power which will increase our chances of capturing any treatment effect. The study will provide interpretable data that will give us the confidence to design future studies for patients. Furthermore, it is significantly more attractive for patients to participate in a study without a placebo group as they are certain to be treated with the active substance”, says Rohit Batta, CMO of Vicore Pharma.
“This is a clever and patient friendly design that will indicate whether C21 works in IPF. IPF continues to have a high unmet need and new treatments are desperately needed”, says Professor Joanna Porter, University College of London, Chief Investigator of the trial.
IPF is a debilitating lung disease with a prognosis worse than most cancers. There are no existing treatments that can reverse the fibrosis or cure IPF. Vicore anticipates recruitment of patients to the trial to start in Q3 2020. The study will include approximately 60 patients and it will be performed in the UK with the possibility to expand to additional countries.
For further information, please contact:
Carl-Johan Dalsgaard, CEO, tel: +46 70 975 98 63, email@example.com