Clinical Trials – Phase IIb mixed dyslipidemia trial.

The company anticipates concluding the trial by the end of this year; topline results will be reported in the first half of next year.
mixed dyslipidemia

Phase IIb mixed dyslipidemia trial.

Arrowhead Pharmaceuticals has concluded the subject enrollment as planned in the Phase IIb clinical trial of ARO-ANG3 to treat mixed dyslipidemia patients.

A total of 182 subjects were currently enrolled into the trial. The company anticipates concluding the trial by the end of this year, while topline results will be reported in the first half of next year.

Named ARCHES-2 or AROANG3-2001, the placebo-controlled, double-blind trial will analyze the safety and efficacy of ARO-ANG3 to treat mixed dyslipidemia in adult patients.

The study will also enroll up to nearly 20 additional subjects, who were being screened when the trial reached the planned full enrollment.

All dose arms enrolled a minimum of 60 subjects, who were randomised into a 3:1 ratio to receive either a subcutaneous dose of ARO-ANG3 or placebo on day one and week 12.

ARO-ANG3’s three dose levels, 50mg, 100mg and 200mg, will be analyzed against placebo in the trial subjects.

From screening to the end-of-trial examination week 36, the study will last nearly 42 weeks.

mixed dyslipidemia

On concluding the week 36 visit, subjects will be eligible to continue in an open-label extension period.

Assessing the safety and efficacy of ARO-ANG3 in adult mixed dyslipidemia patients will be the primary objective of the trial.

The trial will also detect an optimal dose and dosing regimen for further trials in these patients.

Arrowhead chief medical officer Javier San Martin said: “Arrowhead’s investigational ARO-ANG3 is designed to silence the hepatic expression of angiopoietin-like protein 3 (ANGPTL3), a liver synthesized inhibitor of lipoprotein lipase and endothelial lipase.

“ANGPTL3 inhibition has been shown to lower serum and liver triglycerides, serum LDL cholesterol, and has genetic validation as a novel target for cardiovascular disease.”

The latest development comes after the company dosed the first subjects in the Phase I/II trial of ARO-C3 to potentially treat various complement-mediated diseases.

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