Pronova's PRC-4016 enters Phase I clinical trial for treatment of combined dyslipidemia
Pronova BioPharma ASA announced that it has started dosing in a Phase I clinical trial of PRC-4016, a new chemical entity for the treatment of combined dyslipidemia.
The First-in-Human clinical trial is a double-blind, placebo-controlled, single and multiple oral dose study to investigate the safety, tolerability and pharmacokinetics of PRC-4016. The study, conducted in healthy volunteers, will be performed in the UK. Results are expected in the first quarter of 2012.
PRC-4016 is the first of a number of new chemical entities to emerge from Pronova BioPharma's research into omega-3 fatty acid derivatives since the launch of the blockbuster drug Omacor®. The drug is a structurally modified omega-3 fatty acid, which has been shown to have potent triglyceride and bad (non-HDL) cholesterol lowering effects while raising good (HDL) cholesterol in pre-clinical studies.
The clinical profile targets both primary and secondary dyslipidemia associated with cardiovascular and metabolic disease, and in particular combined dyslipidemia characterised by elevated triglycerides, low good (HDL) cholesterol and elevated bad (non-HDL) cholesterol. Combined dyslipidemia has been shown to play an important role in the development of cardiovascular diseases. The prevalence of dyslipidemia across the seven largest pharmaceutical markets is estimated at approximately 270 million people with diagnosis rates of approximately 35-40 per cent.
Morten Jurs, CEO of Pronova BioPharma, commented, "This is an important milestone for Pronova BioPharma and for the development of our pipeline of omega-3-derived products. We believe PRC-4016 has an optimal profile to set new standards in the treatment of dyslipidemia, where there is a significant medical need for approaches capable of reducing triglycerides and non-HDL-C levels in the blood while raising levels of HDL-C. Current approaches do not achieve all of these goals and have a narrow therapeutic window as well as unwanted side effects."
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