Clinical-stage biopharmaceutical firm Laboratoris Sanifit has enrolled the first patient in CaLIPSO, a Phase IIb study of SNF472 to treat cardiovascular calcification (CVC) in end-stage-renal-disease (ESRD) patients for haemodialysis (HD).
SNF472 is an intravenous drug designed to selectively block the pathological cardiovascular calcification progression, leading to the decrease of cardiovascular events in dialysis patients and in the case of calciphylaxis.
CaLIPSO trial is a 52-week, double-blind, randomised, placebo-controlled study that assesses the effects of SNF472 300 and 600mg doses, on the progression of cardiovascular calcification (CVC).
To be conducted at approximately 75 investigation sites in the US, Spain, Italy and the UK, the firm plans to enrol 400 patients in the study.
The results of CaLIPSO trail are expected to be reported in 2019.
Sanifit chief executive officer Joan Perelló said: "SNF472 selectively blocks the pathological cardiovascular calcification progression and we are delighted to initiate this trial.
"We believe SNF472 has significant potential as a novel treatment of cardiovascular calcification for ESRD patients suffering from this life-threatening clinical condition.
"We have assembled a strong management team and look forward to progressing the development of our lead compound for this high unmet medical need."
The firm has also initiated a Phase II clinical trial to evaluate SNF472 for the treatment of calciphylaxis.
The drug has secured orphan drug designation from the European Medical Agency (EMA) in June 2012 and the US Food and Drug Administration (FDA) in December 2012.