Date: 2011-09-19
Type of information:
phase: 1
Announcement: initiation
Company: Pronova BioPharma (Norway)
Product: PRC-4016
Action mechanism: 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.
Disease: combined dyslipidemia
Therapeutic area: Metabolic diseases Cardiovascular diseases
Country: UK
Trial details: 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.
Latest news: Pronova BioPharma has started dosing in a Phase I clinical trial of PRC-4016, a new chemical entity for the treatment of combined dyslipidemia. 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. Results are expected in the first quarter of 2012
