Date: 2011-06-16
Type of information:
phase:
Announcement: preparation of the submission of a CTA
Company: Pronova BioPharma (Norway)
Product: PRC-4016
Action mechanism: PRC-4016 is a structurally enhanced omega-3 fatty acid with potent triglyceride and cholesterol lowering effects.
Disease: mixed dyslipidemia
Therapeutic area: Cardiovascular diseases
Country: UK
Trial details:
Latest news: Pronova BioPharma has announced pre-clinical results of PRC-4016, a new chemical entity for the treatment of mixed dyslipidemia. The company is preparing to submit a CTA (Clinical Trial Application) for PRC-4016 in Europe, with the first patients expected to be dosed in September 2011. The Phase I trial will involve 80-120 subjects and be conducted in the UK. PRC-4016 will be tested in single and multiple escalating doses. Phase II studies are expected to begin in H1 2012. Results of pre-clinical studies of PRC-4016 indicate that PRC-4016 was shown to be more potent than fenofibrate in lowering both triglycerides and LDL cholesterol. PRC-4016 also increased HDL cholesterol more than the corresponding dose of fenofibrate in mouse models.
