NattoPharma - First Step Into The Pharmaceutical Market
Lysaker - Today it was agreed that NattoPharma’s natural vitamin K2, MenaQ7®, will be used in the VitaVasK study, a placebo-controlled, double-blind multinational European randomized trial. The hypothesis that the dietary supplementation of MenaQ7® can delay the progression of vascular and valvular calcification in patients on chronic hemodialysis will be tested. The study will last for three years and will measure placebo controlled the effect of high doses of MenaQ7® in some 600 kidney patients over one and a half years. VitaVasK is being financed by a 1,8mill grant from the European Renal Association.
Patients on hemodialysis (HD) exhibit an enormous increase in cardiovascular mortality associated with extensive vascular calcification (VC). Matrix Gla protein (MGP) is a powerful inhibitor of VC. MGP is produced by vascular smooth muscle cells and is activated (carboxylated) by vitamin K. “The proposed VitaVasK study will be the first clinical trial in HD patients to target the progression of VC using dietary vitamin K-mediated supplements”, says principle investigator Prof Jürgen Floege, head of the nephrology department at the University Hospital of the RWTH Aachen University, in Germany.
Studies carried out at Maastricht University, in collaboration with NattoPharma, indicate that MenaQ7® has the potential to prevent or even reduce vascular calcification. Especially in patients prone to vascular calcification, such as those with chronic kidney disease, this calcification reduction may positively influence patient outcome. In a pilot study, it was shown that hemodialysis patients revealed an extreme vitamin K deficiency and inactive MGP, indicating that they do not have the ability to protect against arterial calcification. It was shown that six weeks of MenaQ7® supplementation increased the active MGP levels in these patients in a dose-dependent manner, suggesting that disturbed calcification inhibitory activity in the vasculature may be improved by MenaQ7® supplementation, hopefully leading to a better outcome for dialysis patients.
According to one of the principle investigators of the Vitamin K2 study in dialysis patients, Dr Leon Schurgers, senior scientist at Maastricht University and VP of R&D at NattoPharma, “Calcification of the arteries seen in chronic kidney disease is the same type of calcification which is found in aging populations. The accumulation of calcium salts in the arteries results in stiffening and increased fragility. This might be considered a ’silent killer’ as hardening of the arteries develops without any symptoms over time.” Further, he stated that current evidence now indicates that “the process of calcification is an actively regulated process and that adequate MenaQ7® intake can prevent this process and eliminate this risk factor.”
Prof Peter Stenvinkel, nephrologist at the Karolinska institute explains, “Whereas 500.000 people in Europe and the USA suffer from dialysis-dependent chronic kidney disease, signs of mild to moderate CKD (Chronic Kidney Disease) are found in more than 10 million patients. Compared to the general population, patients with advanced chronic kidney disease experience a 10 - 100x increased risk of cardiovascular complications, which translates into a mortality risk comparable to the one found in patients with mestastatic cancer disease. This problematic situation is further complicated by the fact that many treatment strategies (including statins, increased dialysis dose and erythropoietin), in randomized controlled trials have not been shown to improve survival in this patient group. A major problem in dialysis patients is accelerated vascular calcification; a process that increases the risk of cardiovascular complications and premature death. As this deleterious process may be accelerated by a subclinical deficiency of vitamin K2, MenaQ7® supplementation may be a novel beneficial treatment strategy to slow down the calcification process and lower the risk of cardiovascular complications without troublesome side effects in this unfortunate patient group.”
“We see this as our first step into the pharmaceutical market. Until now, we have only done trials in healthy subjects. Now, for the first time, we are part of a large trial in dialysis patients suffering from a disease with a high mortality. Thus, if this trial is successful, we see a great potential for MenaQ7® as a drug in the future” says Morten Sundstø, CEO of NattoPharma.
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