Data from first in-human clinical trial of SNF472 in haemodialysis patients published in British Journal of Clinical Pharmacology
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Laboratoris Sanifit S.L., a clinical-stage biopharmaceutical company focused on treatments for calcification disorders, today announces that data from a phase I study assessing the safety and tolerability of its lead drug candidate SNF472 in haemodialysis patients has been published in the British Journal of Clinical Pharmacology.
SNF472 is a novel calcification inhibitor being developed for the treatment of cardiovascular disease linked to calcification in haemodialysis (HD), a major factor in morbidity and mortality among the HD patient population. This double-blind, randomized, placebo-controlled study investigated the safety, tolerability and pharmacokinetics of intravenously administered SNF472 in 28 healthy volunteers and HD patients.
Data from this study demonstrated acceptable safety and tolerability with no significant adverse events, as well as a lack of significant removal of IV SNF472 drug during dialysis at the selected doses. Pharmacodynamic analyses also demonstrated that SNF472 administration reduced hydroxyapatite crystallization potential in HD patients.
“We are pleased with the promising results of this first-in-human study,” commented Dr. Joan Perelló, Chief Executive Officer of Sanifit “These data clearly show that SNF472 has strong potential as a novel treatment for cardiovascular calcification in end-stage renal disease; a significant, underserved market with no approved therapies. This provides us with further validation as we progress SNF472 through the clinic.”
The full article; First-time-in-human randomized clinical trial in healthy volunteers and haemodialysis patients with SNF472, a novel inhibitor of vascular calcification, published in the British Journal of Clinical Pharmacology can be accessed here.