Catabasis Pharmaceuticals has commenced a Phase I study of CAT-2003 for the treatment of severe hypertriglyceridemia in healthy volunteers and in adults with mildly elevated lipids.
The randomised study will assess the safety, tolerability and pharmacokinetics of CAT-2003, a conjugate of niacin and eicosapentaenoic acid (EPA) covalently linked using the company’s Smart Linker technology to form a new chemical entity.
"In preclinical animal models, CAT-2003 produced robust triglyceride and low density lipoprotein (LDL) cholesterol lowering, and synergistic reductions in LDL cholesterol when CAT-2003 was combined with a statin," Jirousek said.
The results from the placebo-controlled study, which will be conducted in two parts, are expected in the second quarter of 2013.
Healthy adults will be administered with a single ascending dose of CAT-2003 or placebo in the first part of the study.
In the second part, CAT-2003 or placebo will be administered each day for 14 days in healthy adults or patients with mildly elevated lipids.
The double-blind study will also assess triglycerides, LDL cholesterol and biomarkers related to the mechanism of action of CAT-2003.
CAT-2003 demonstrated a significant and dose-dependent reduction in plasma triglycerides in preclinical models of severe hypertriglyceridemia and LDL cholesterol reduction in preclinical models of dyslipidemia.