Catabasis commences Phase I hypertriglyceridemia study of CAT-2003

26th March 2013 (Last Updated March 26th, 2013 18:30)

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.

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.

"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.