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Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) has successfully completed enrollment for the Phase 2b ARCHES-2 clinical study of its investigational RNAi therapeutic, ARO-ANG3, targeting mixed dyslipidemia with over 180 participants. The trial aims to assess the safety and efficacy of various doses, with topline data expected in the first half of 2023. The study evaluates the ability of ARO-ANG3 to inhibit ANGPTL3, which plays a role in lipid metabolism. Results will inform future late-stage clinical trials.
Positive
Successful enrollment of over 180 participants in the Phase 2b ARCHES-2 clinical trial.
Topline data from the trial is anticipated in the first half of 2023, potentially advancing the drug's development.
Investigational ARO-ANG3 targets ANGPTL3, a validated target for cardiovascular disease.
Negative
None.
- Topline data expected in the first half of 2023
PASADENA, Calif.--(BUSINESS WIRE)--
Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it has reached full planned enrollment of more than 180 participants in the Phase 2b ARCHES-2 clinical study of ARO-ANG3, the company’s investigational RNA interference (RNAi) therapeutic being developed as a treatment for patients with mixed dyslipidemia. Completion of ARCHES-2 is anticipated around the end 2022 and the company intends to release topline data in the first half of 2023.
Javier San Martin, M.D., chief medical officer at Arrowhead, 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 ARCHES-2 clinical study will evaluate safety and efficacy and identify an optimal dose and dosing regimen of ARO-ANG3 to be assessed in future late-stage clinical studies. I want to thank the participating investigators and our entire clinical team for their hard work to enroll this study rapidly and effectively. We look forward to sharing topline data for ARCHES-2 in the first half of 2023.”
ARCHES-2, also called AROANG3-2001 (NCT04832971), is a double-blind, placebo-controlled Phase 2b study to evaluate the efficacy and safety of investigational ARO-ANG3 in adults with mixed dyslipidemia. Three dose levels of ARO-ANG3 (50 mg, 100 mg, and 200 mg) will be evaluated against placebo in participants with mixed dyslipidemia who had the following at screening: (i) low-density lipoprotein cholesterol (LDL-C) greater than or equal to 70 mg/dL (1.8 mmol/L) or non-high-density lipoprotein cholesterol (non-HDL-C) greater than or equal to 100 mg/dL (2.59 mmol/L) and (ii) mean fasting triglycerides (TG) greater than or equal to 150 mg/dL (1.69 mmol/L) but less than or equal to 499 mg/dL (5.61 mmol/L). A total of 182 participants have been enrolled in the study. Up to approximately 20 additional participants that were still in screening when the study reached full enrollment may also be enrolled. All dose cohorts were enrolled in parallel with at least 60 participants per cohort randomly assigned in a 3:1 ratio to receive a subcutaneous injection of ARO-ANG3 or placebo on day 1 and week 12. The duration of the study is approximately 42 weeks from screening to the week 36 end-of-study examination. After completing the week 36 visit, participants will be eligible to continue in an open-label extension period. The primary objective of the ARCHES-2 study is to evaluate the safety and efficacy of ARO-ANG3 in adults with mixed dyslipidemia and select a dosing regimen for later stage clinical studies in this patient population.
About Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
Safe Harbor Statement under the Private Securities Litigation Reform Act:
This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “hope,” “intend,” “plan,” “project,” “could,” “estimate,” or “continue” are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our business, expectations for our product pipeline or product candidates, including anticipated regulatory submissions and clinical program results, prospects or benefits of our collaborations with other companies, or other characterizations of future events or circumstances are forward-looking statements. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties, including the impact of the ongoing COVID-19 pandemic on our business, the safety and efficacy of our product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, our ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, the enforcement of our intellectual property rights, and the other risks and uncertainties described in our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other documents filed with the Securities and Exchange Commission from time to time. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.
What is the purpose of the ARCHES-2 clinical study for ARWR?
The ARCHES-2 study aims to evaluate the safety and efficacy of ARO-ANG3 in treating adults with mixed dyslipidemia.
When will topline data from the ARCHES-2 study be released?
Topline data from the ARCHES-2 clinical trial is expected to be released in the first half of 2023.
How many participants are enrolled in the ARCHES-2 study?
More than 180 participants have been enrolled in the ARCHES-2 clinical study.
What are the dosing levels being evaluated in the ARCHES-2 study?
The study evaluates three dosing levels of ARO-ANG3: 50 mg, 100 mg, and 200 mg.
What is the significance of ARO-ANG3 targeting ANGPTL3?
Targeting ANGPTL3 is significant as it can lead to reductions in liver and serum triglycerides and LDL cholesterol, which are critical factors in cardiovascular disease.
