US-based clinical stage biotechnology firm Catabasis Pharmaceuticals has started the second Phase II clinical trial to assess the safety and efficacy of CAT-2003 in patients with severe hypertriglyceridemia, defined as serum triglyceride levels of 500mg/dL or greater.
CAT-2003 is a new chemical entity that is a SMART Linker conjugate of niacin and the omega 3 fatty acid eicosapentaenoic acid (EPA).
Patients with severe hypertriglyceridemia, either naive or refractory to current therapy, will be treated for 28 days in the trial.
The primary endpoint is change from baseline in fasting triglycerides, while secondary endpoints include changes from baseline in postprandial total and chylomicron triglyceride levels.
The company expects that the top-line results from the trial will be released in mid-2014.
Catabasis co-founder and chief executive officer Jill Milne said: “We believe that CAT-2003 may effectively reduce both fasting and postprandial triglyceride levels in these patients, potentially offering a differentiated efficacy profile.”
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The Phase II trial programme for CAT-2003 includes an ongoing Phase II trial in patients with hypertriglyceridemia and in combination with statins in patients with hypercholesterolemia.
The company said that in animal models of severe hypertriglyceridemia, significant and dose-dependent reductions in plasma triglycerides were observed with CAT-2003, while in animal models of dyslipidemia, it reduced LDL cholesterol.
In a Phase I clinical trial, CAT-2003 showed reductions in fasting and post-prandial triglyceride levels and had positive effects on lipid biomarkers including reductions in LDL, apolipoprotein C-III (ApoC-III), ApoB and PCSK9.