A first-in-human clinical trial of a new drug has generated promising results in reducing vascular calcification of hemodialysis patients.
Vascular calcification is the leading cause of death in patients with end-stage renal disease undergoing hemodialysis. According to The US Renal Data System, nearly 50% of patients with end-stage renal disease die of vascular disease, due to the rapidly progressing atherosclerotic burden and heavy arterial calcification. For patients above 60 years, their life expectancy is lower than 4.5 years in the US, and the survival rate is strongly correlated with the calcification level.
No drug to treat vascular calcification
Current strategies to control the rate of progression of vascular calcification rely on the management of an individual’s calcium and phosphate levels. These could be done by manipulating dietary intake and managing vitamin D status. No drug has, however, been approved to date, specifically for the treatment of vascular calcification.
First-in-human clinical trial shows promising results
In a recent study published in The British Journal of Clinical Pharmacology, a group of researchers from Spain conducted a clinical trial to evaluate the safety, tolerability, and pharmacokinetic activity of a new drug, which inhibits calcification. The new formulation, SNF472, is an intravenous injectable drug consisting of naturally-occurring substance IP6 which is beneficial for treating calcium-related diseases.
This first-in-human, double-blind, randomized, placebo-controlled clinical trial was conducted at three different hospitals in the United Kingdom (UK). The researchers randomly divided eight male patients aged 45-74 years into two groups, either receiving SNF472 or matching placebo. These patients were all undergoing standard hemodialysis three times a week at the point of the study. After receiving various doses and dosing schedules, patients were monitored for hypocalcemia by assessing clinical vital signs and measuring calcium levels in blood throughout the study period.
Drug may soon be available on the market
The results from this study showed promising safety and tolerability. Patients received SNF472 administration showed remarkably reduced calcium crystallization level by 80 %. This exciting study supports the benefit of administrating SNF472 calcification inhibitor for treating patients who suffer from the devastating consequences of accelerated vascular calcification. It is expected that soon this experimental drug will be available to the market.
Written by Man-tik Choy, Ph.D
Reference: Perelló J. et al. First-time-in-human randomized clinical trial in healthy volunteers and haemodialysis patients with SNF472, a novel inhibitor of vascular calcification. British Journal of Clinical Pharmacology. 2018. DOI: 10.1111/bcp.13752.