Positive data from Sanifit’s Phase 2b CaLIPSO trial of SNF472 published in Circulation
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Sanifit today announced that the positive topline results from the CaLIPSO phase 2b international clinical trial of SNF472 have been published in Circulation, the journal of the American Heart Association. The trial met its primary endpoint, demonstrating significantly reduced progression of coronary artery calcium (CAC) volume in patients treated with SNF472 compared to placebo.
The CaLIPSO trial was a 52-week, double-blind, randomized, placebo-controlled trial assessing SNF472, a selective inhibitor of the formation and growth of hydroxyapatite crystals, in patients with ESKD on hemodialysis. The trial compared progression of CAC volume score and other measurements of cardiovascular calcification (CVC) by CT scan during 52 weeks of treatment with SNF472 or placebo, in addition to standard therapy, in adult patients with ESKD receiving hemodialysis. Patients were randomized 1:1:1 to SNF472 300 mg (n=92), SNF472 600 mg (n=91), or placebo (n=91) thrice weekly during hemodialysis sessions.
The primary endpoint was change in CAC volume score from baseline to week 52. The primary analysis combined the SNF472 treatment groups and included all patients who received at least one dose of SNF472 or placebo and had a post-randomization evaluable CT scan. The study was conducted at 65 investigational sites in the US, Spain and the UK.