PASADENA, Calif.--(BUSINESS WIRE)--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has filed for regulatory clearance to initiate a Phase 1/2a clinical trial of ARO-INHBE, the company’s investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for obesity.

加利福尼亚州帕萨迪纳（商业新闻短讯）--箭头制药公司（NASDAQ:ARWR）今天宣布，它已申请监管部门的批准，启动ARO-INHBE的1/2a期临床试验，该公司的研究性RNA干扰（RNAi）治疗剂正在开发中，作为肥胖的潜在治疗方法。

Arrowhead also plans to file for regulatory clearance before the end of 2024 to initiate a clinical trial for its second obesity candidate, ARO-ALK7..

箭头还计划在2024年底前申请监管部门的批准，为其第二位肥胖候选人ARO-ALK7启动临床试验。。

“Arrowhead’s two investigational RNAi therapies for the treatment of obesity, ARO-INHBE and ARO-ALK7, are both designed to intervene in the same pathway that signals the body to store fat in adipose tissue. We have generated very promising preclinical data that suggests inhibition of these targets reduces body mass and fat mass but spares lean muscle mass resulting in improved body composition,” said James Hamilton, M.D., Chief of Discovery and Translational Medicine at Arrowhead.

“Arrowhead的两种用于治疗肥胖症的RNAi研究疗法ARO-INHBE和ARO-ALK7都旨在干预同一途径，该途径指示身体将脂肪储存在脂肪组织中。我们已经产生了非常有希望的临床前数据，表明抑制这些靶标可以减少体重和脂肪量，但可以减少瘦肌肉量，从而改善身体成分，”Arrowhead的发现和转化医学负责人詹姆斯·汉密尔顿医学博士说。

“We have designed the initial Phase 1/2 study to evaluate single and multiple doses of ARO-INHBE monotherapy in Part 1 which will enroll patients with obesity, and to evaluate multiple doses of ARO-INHBE in combination with tirzepatide in Part 2 which will enroll diabetic and non-diabetic patients with obesity.

“我们设计了最初的1/2期研究，以评估第一部分中的单剂量和多剂量ARO-INHBE单一疗法，该疗法将招募肥胖患者，并评估第二部分中的多剂量ARO-INHBE联合tirzepatide，该疗法将招募糖尿病和非糖尿病肥胖患者。

We believe new therapeutic strategies with novel mechanisms of action, like ARO-INHBE and ARO-ALK7, have the potential to make a significant impact on the way obesity is treated and we are eager to initiate clinical studies of these important new programs.”.

我们相信具有新作用机制的新治疗策略，如ARO-INHBE和ARO-ALK7，有可能对肥胖的治疗方式产生重大影响，我们渴望启动这些重要新项目的临床研究。”。

ARO-INHBE is designed to reduce the hepatic expression of the INHBE gene and its secreted gene product, Activin E. INHBE is a promising genetically validated target in which loss-of-function INHBE variants in humans are associated with lower risk of obesity and metabolic diseases, such as type 2 diabetes.

ARO-INHBE旨在降低INHBE基因及其分泌基因产物激活素E的肝脏表达。INHBE是一种有前途的基因验证靶标，其中人类功能丧失的INHBE变异与肥胖和代谢疾病（如2型糖尿病）的风险降低有关。

Activin E acts as a ligand in a pathway that regulates energy homeostasis in adipose tissue​. Intervening in this pathway with investigational ARO-INHBE treatment has the potential to increase lipolysis, and reduce adipose hypertrophy and dysfunction, visceral adiposity, and insulin resistance..

。。

An application for approval to initiate the clinical trial was submitted to the New Zealand Medicines and Medical Devices Safety Authority for review by the Standing Committee on Therapeutic Trials. Pending clearance, Arrowhead intends to proceed with AROINHBE-1001, A Phase 1/2a dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-INHBE in up to 78 adult volunteers with obesity.

启动临床试验的批准申请已提交给新西兰药品和医疗器械安全局，供治疗试验常设委员会审查。在获得批准之前，Arrowhead打算继续进行AROINHBE-1001，这是一项1/2a期剂量递增研究，旨在评估ARO-INHBE在多达78名肥胖成年志愿者中的安全性，耐受性，药代动力学和药效学。

Part 1 of the study is designed to assess single and multiple doses of ARO-INHBE monotherapy, and Part 2 of the study is designed to assess ARO-INHBE in combination with tirzepatide, a subcutaneously administered GLP-1/GIP receptor co-agonist that has been approved in the United States and the European Union for management type 2 diabetes mellitus since 2022 and weight management since 2023/2024 respectively..

该研究的第1部分旨在评估单剂量和多剂量的ARO-INHBE单药治疗，第2部分旨在评估ARO-INHBE联合tirzepatide，tirzepatide是一种皮下注射的GLP-1/GIP受体共激动剂，已被美国和欧盟分别批准用于自2022年以来的2型糖尿病管理和自2023/2024年以来的体重管理。。

About Arrowhead Pharmaceuticals

关于箭头制药

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.

箭头制药公司（Arrowhead Pharmaceuticals）通过沉默导致顽固性疾病的基因来开发治疗顽固性疾病的药物。使用广泛的RNA化学组合和有效的递送方式，箭头疗法触发RNA干扰机制，以诱导靶基因的快速，深入和持久的敲低。

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..

RNA干扰或RNAi是活细胞中存在的一种机制，可抑制特定基因的表达，从而影响特定蛋白质的产生。Arrowhead基于RNAi的疗法利用了这种基因沉默的自然途径。。

For more information, please visit www.arrowheadpharma.com, or follow us on X (formerly Twitter) at @ArrowheadPharma or on LinkedIn. To be added to the Company's email list and receive news directly, please visit http://ir.arrowheadpharma.com/email-alerts.

欲了解更多信息，请访问www.arrowheadharma.com，或通过X（以前的推特）关注我们@arrowheadharma或LinkedIn。要添加到公司的电子邮件列表并直接接收新闻，请访问http://ir.arrowheadpharma.com/email-alerts.

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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.

此外，任何涉及我们未来财务业绩预测、业务趋势、对我们产品线或候选产品的期望（包括预期的监管提交和临床计划结果）、我们与其他公司合作的前景或益处，或未来事件或情况的其他特征的声明都是前瞻性声明。

These forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; our expectations regarding the potential benefits of the partnership, licensing and/or collaboration arrangements and other strategic arrangements and transactions we have entered into or may enter into in the future; our beliefs and expectations regarding milestone, royalty or other payments that could be due to or from third parties under existing agreements; and our estimates regarding future revenues, research and development expenses, capital requirements and payments to third parties.

这些前瞻性陈述包括但不限于关于我们的临床前研究和临床试验以及我们的研究和开发计划的开始，时间，进展和结果的陈述；我们对合作伙伴关系、许可和/或合作安排以及我们已经达成或将来可能达成的其他战略安排和交易的潜在利益的期望；我们对里程碑、特许权使用费或现有协议下可能应付给第三方或来自第三方的其他付款的信念和期望；以及我们对未来收入、研发费用、资本要求和向第三方付款的估计。

These statements are based u.

这些声明基于美国。

Source: Arrowhead Pharmaceuticals, Inc.

来源：Arrowhead Pharmaceuticals，Inc。