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Novel Inhibitor of Vascular Calcification Tested in Clinical Trial of Haemodialysis Patients

Cardiovascular calcification is a major health concern in patients with kidney failure undergoing haemodialysis. A first-time-in-human clinical trial of an investigational calcification inhibitor has generated promising results in terms of safety, tolerability, and pharmacokinetics. The findings are published in the British Journal of Clinical Pharmacology.

Wednesday, October 3, 2018 12:01 am EDT
"We are very proud of this first-in-human trial, which reveals a linear and predictable pharmacokinetic behavior and strengthens the excellent safety profile of SNF472"

Cardiovascular calcification is a major health concern in patients with kidney failure undergoing haemodialysis. A first-time-in-human clinical trial of an investigational calcification inhibitor has generated promising results in terms of safety, tolerability, and pharmacokinetics. The findings are published in the British Journal of Clinical Pharmacology.

The drug, called SNF472, is being studied in additional clinical trials, using various doses and dosing schedules. A phase 1b study was completed in 2016, evaluating the safety, tolerability, and pharmacokinetic and pharmacodynamic activity of SNF472 at repeated dosing in haemodialysis patients. A phase 2 proof of concept study in calciphylaxis patients undergoing haemodialysis was successfully finalized in early 2018, suggesting a positive effect of SNF472 on wound healing and pain in this very ill patient population. A 270-patient, phase 2b, randomized, placebo-controlled study is evaluating the effect of SNF472 in attenuating cardiovascular calcification over 1 year in haemodialysis patients.

“We are very proud of this first-in-human trial, which reveals a linear and predictable pharmacokinetic behavior and strengthens the excellent safety profile of SNF472”, said senior author Dr. Carolina Salcedo, of Laboratoris Sanifit, in Spain.

“This study is just the first step of an ambitious clinical development program with SNF472 to address severe unmet medical needs in patients who suffer from the devastating consequences of accelerated cardiovascular calcification. We are hopeful that in the near future this experimental drug will be available to calciphylaxis and haemodialysis patients”, added senior author Dr. Joan Perelló, also of Laboratoris Sanifit.

Peer Reviewed, Retrospective Study, Human

Additional Information

Link to Study: https://onlinelibrary.wiley.com/doi/10.1111/bcp.13752

About Journal

Published on behalf of the British Pharmacological Society, the British Journal of Clinical Pharmacology contains papers and reports on all aspects of drug action in humans: review articles, mini review articles, original papers, commentaries, editorials and letters. The Journal enjoys a wide readership, bridging the gap between the medical profession, clinical research and the pharmaceutical industry. It also publishes research on new methods, new drugs and new approaches to treatment.

About Wiley

Wiley is a global leader in education and scholarly research. Our online scientific, technical, medical, and scholarly journals, combined with our digital learning, assessment and certification solutions help universities, learned societies, businesses, governments and individuals increase the academic and professional impact of their work. For more than 210 years, we have delivered consistent performance to our stakeholders. The company's website can be accessed at www.wiley.com.

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