Press release
Arrowhead Presents New Clinical Data on Cardiometabolic Candidates ARO-APOC3 and ARO-ANG3 at AHA Scientific Sessions 2019
- Company Expects to Initiate Phase 3 Clinical Trials Next Year PASADENA, Calif.--(BUSINESS WIRE)-- Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today
About this update from Arrowhead Pharmaceuticals, Inc.
[{"type":"text","content":"\n- Company Expects to Initiate Phase 3 Clinical Trials Next Year\n\n PASADENA, Calif.--(BUSINESS WIRE)--\nArrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today presented updated Phase 1 clinical data on its two RNAi-based cardiometabolic candidates, ARO-APOC3 targeting apolipoprotein C-III (APOC3) being developed as a potential treatment for patients with severe hypertriglyceridemia and familial chylomicronemia syndrome (FCS), and ARO-ANG3 targeting angiopoietin like protein 3 (ANGPTL3) being developed for the treatment of dyslipidemias, such as homozygous familial hypercholesterolemia (HoFH), and metabolic diseases. The data were presented in two late-breaking oral presentations at the American Heart Association (AHA) Scientific Sessions 2019, in Philadelphia.\n\n\nBruce Given, M.D., chief operating officer and head of R&D at Arrowhead, said: “The data presented at AHA on cardiometabolic candidates ARO-APOC3 and ARO-ANG3 are further validation of the TRiM™ platform and Arrowhead’s ability to consistently develop RNAi therapeutics that achieve deep and durable levels of gene knockdown across a broad range of targets. In particular, the knockdown in APOC3 and ANGPTL3 proteins and the resulting reductions in triglycerides and various lipid parameters strongly support our plan to initiate Phase 3 studies in 2020.”\n\n\nPresentation Details:\n\n\nRNA Interference Targeting Apolipoprotein C-III Results in Deep and Prolonged Reductions in Plasma Triglycerides\n\n\n\nSession: Late Breaking Science VI: New Frontiers in Lipid Therapy\n\n\nDate and Time: November 18, 2019 from 9:32 AM EST\n\n\nAuthors: Dr. Christie Ballantyne, presenting on behalf of Dr. Christian Schwabe, et al.\n\n\n\nKey points presented on the AROAPOC31001 Phase 1/2a clinical study included the following:\n\n\n\nSafety and tolerability\n\n\n40 subjects enrolled to receive a single dose (24 active, 16 placebo)\n\n\nNo serious or severe adverse events (AEs) reported\n\n\nOne AE of moderate transient ALT elevation (peak of 210 U/L on Day 22) in a subject receiving ARO-APOC3 who had elevated ALT at baseline (65 U/L), with return to baseline by Day 85 (61 U/L).\n\n\n8 Local Injection Site Reactions (LISRs) – all rated mild, more common at higher doses\n\n\n\n\nActivity\n\n\nDose dependent reductions in serum APOC3 were observed\n\n\nMean maximum reduction from baseline in s...