ARWR - Arrowhead says anti-lipid agent caused up to 48% decline in bad cholesterol

2023-05-23 12:15:47 ET

Arrowhead Pharmaceuticals ( NASDAQ: ARWR ) announced Tuesday that patients with a rare form of hypercholesterolemia indicated a 44% – 48% reduction of LDL-Cholesterol, also known as “bad” cholesterol, after receiving its experimental RNAi therapeutic ARO-ANG3.

Citing interim data from its ongoing Phase 2 GATEWAY study, Arrowhead ( ARWR ) said that the results support its plans to further investigate ARO-ANG3 in a Phase 3 study for the condition known as homozygous familial hypercholesterolemia ((HoFH)).

The company plans to conduct a Phase 3 trial for ARO-ANG3 and intends to engage regulators in H2 2023 to discuss a proposed study design.

“Despite advances in the treatment of cardiovascular disease associated with high LDL-cholesterol, patients with HoFH have a particularly high need for additional therapy,” the chief medical officer of Arrowhead ( ARWR ) Javier San Martin remarked.

HoFH is a rare form of familial hypercholesterolemia, which can cause early indications of coronary artery disease if untreated.

Arrowhead’s ( ARWR ) GATEWAY study for 18 patients demonstrated that the administration of ARO-ANG3 at 200 mg or 300 mg on day one and day 84 caused a 48.1% and 44.0% decline in LDL-C at Week 20, respectively.

There were no discontinuations and dose interruptions due to treatment-emergent adverse events. However, there was an incidence of atrioventricular block that investigators classified as a serious adverse event unrelated to ARO-ANG3.

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