Arrowhead Presents New Phase 2 Data at AHA 2022 on Cardiometabolic Pipeline
- ARO-APOC3 decreased triglycerides by 86%, and non-HDL-C by 45% while increasing HDL-C by 99% in patients with severe hypertriglyceridemia
- ARO-ANG3 decreased triglycerides by 59%, LDL-C by 32%, and was associated with a relative reduction in liver fat fraction in patients with mixed dyslipidemia
- Olpasiran reduced lipoprotein(a) levels by more than 95% in patients with established ASCVD
- Company will host a virtual analyst and investor event on
“Our team and our partners at Amgen collectively showed promising new clinical data across three late-breaking AHA 2022 presentations on investigational candidates, ARO-APOC3, ARO-ANG3, and olpasiran, which were all developed utilizing Arrowhead’s proprietary Targeted RNAi Molecule (TRiM™) technology. The totality of these data demonstrates the significant progress achieved in RNAi drug development and they specifically suggest a potential future treatment paradigm where RNAi may be prominently leveraged in preventive cardiology,” said
In the SHASTA-2 study in subjects with severe hypertriglyceridemia who had baseline triglycerides (TGs) of greater than 500 mg/dL, treatment with ARO-APOC3 at doses of 10 mg, 25 mg, and 50 mg all durably decreased APOC3 up to 87%, TGs up to 86%, non-HDL-C up to 45%, and increased HDL-C up to 99% through the week 16 timepoint. ARO-APOC3 has been well tolerated with treatment emergent adverse events reported to date that reflect the underlying comorbidities and conditions of the population under study.
Amgen also presented end-of-treatment data from its Phase 2 OCEAN(a)-DOSE study of TRiM-enabled investigational olpasiran in adults with elevated lipoprotein(a) [Lp(a)] levels (greater than 150 nmol/L) and a history of atherosclerotic cardiovascular disease (ASCVD). These data were presented during the
A copy of the presentation materials and a webcast link for the analyst and investor event will be available on the Events and Presentations page under the Investors section of the Arrowhead website.
ARO-ANG3 is the company’s investigational RNA interference (RNAi) therapeutic designed to silence the hepatic expression of angiopoietin-like protein 3 (ANGPTL3), a liver synthesized inhibitor of lipoprotein lipase and endothelial lipase, being developed as a treatment for patients with mixed dyslipidemia. In the Phase 2
ARO-APOC3 is the company’s investigational RNAi therapeutic targeting apolipoprotein C-III (APOC3) being developed as a treatment for patients with hypertriglyceridemia (HTG), severe hypertriglyceridemia (SHTG), and familial chylomicronemia syndrome (FCS). In the Phase 2 SHASTA-2 clinical study (NCT04720534), eligible subjects (n=177/216 planned subjects) were randomized 3:1 to receive subcutaneous injections of 10, 25, or 50 mg ARO-APOC3 or placebo on day 1 and at week 12. Patients with
OCEAN(a)-DOSE is Amgen’s multicenter, randomized, double-blind, placebo-controlled dose-finding study of olpasiran in 281 patients with established ASCVD and Lp(a) levels >150 nmol/L. Patients were randomized to one of four doses of olpasiran (10 mg Q12 weeks, 75 mg Q12 weeks, 225 mg Q12 weeks or 225 mg Q24 weeks) or placebo, given subcutaneously. Across cohorts, the median baseline Lp(a) concentration was 260.3 nmol/L. Patients who received 75 mg or higher every 12 weeks had a 95% or greater reduction in Lp(a) compared to placebo at week 36. At these doses (75 mg or higher), more than 98% of patients achieved an Lp(a) level of 125 nmol/L or less at week 36. Overall, the rates of adverse events were similar in the olpasiran and placebo arms. The most common treatment-related adverse events were injection site reactions, primarily pain.
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