CHAPEL HILL, N.C.--(BUSINESS WIRE)--Renovion Inc., a biopharmaceutical company focused on developing therapies to restore lung health in individuals with mucus-related lung diseases, announced topline results of the Phase 2 CLIMB study of ARINA-1 in individuals with non-CF bronchiectasis (NCFBE). ARINA-1 is a novel nebulized therapy in development for reducing mucus symptoms in individuals with NCFBE, chronic bronchitis, lung transplant, and other respiratory diseases with chronic mucus symptoms..

北卡罗来纳州教堂山（商业新闻短讯）--生物制药公司Renovion Inc.宣布了ARINA-1在非CF支气管扩张症（NCFBE）患者中的第二阶段爬升研究的结果，该公司专注于开发治疗粘液相关性肺病患者恢复肺健康的疗法。ARINA-1是一种正在开发的新型雾化疗法，用于减轻患有NCFBE，慢性支气管炎，肺移植和其他具有慢性粘液症状的呼吸道疾病的个体的粘液症状。。

The CLIMB study was a randomized double-blind placebo-controlled study to assess the safety and efficacy of ARINA-1 in NCFBE. The trial was conducted at nine sites across the US. Participants were randomized (7:3, treatment:placebo), and 40 participants completed the study, with 29 completing in the ARINA-1 arm and 11 in the placebo (0.9% saline) arm.

CLIMB研究是一项随机双盲安慰剂对照研究，旨在评估ARINA-1在NCFBE中的安全性和有效性。该试验在美国9个地点进行。参与者被随机分配（7:3，治疗：安慰剂），40名参与者完成了研究，其中29名在ARINA-1组完成，11名在安慰剂（0.9%盐水）组完成。

Topline results from the intention-to-treat (ITT) population demonstrate that ARINA-1 is safe and improves quality of life (QOL) in individuals with NCFBE who experience mucus symptoms..

意向治疗（ITT）人群的Topline结果表明，ARINA-1是安全的，可以改善患有粘液症状的NCFBE患者的生活质量。。

'These results highlight the important role that ARINA-1 could play in the treatment of non-CF bronchiectasis and are extremely encouraging for patients,' said Charles Daley, MD, Professor and Chief, Division of Mycobacterial & Respiratory Infections at National Jewish Health in Denver, Colorado and Principal Investigator of the CLIMB trial.

科罗拉多州丹佛National Jewish Health分枝杆菌与呼吸道感染科教授兼科长、医学博士查尔斯·戴利（Charles Daley）说：“这些结果突显了ARINA-1在治疗非CF支气管扩张症方面可能发挥的重要作用，对患者来说非常令人鼓舞。”。

'Today, many [NCFBE] patients suffer from chronic cough and sputum production which affects their QOL and may eventually lead to exacerbations, with no approved pharmaceutical therapies available. There is an urgent need for new effective therapies that can break the vicious cycle of excess mucus, inflammation, and infection for these patients.'.

“今天，许多（NCFBE）患者患有慢性咳嗽和痰液产生，这会影响他们的生活质量，并可能最终导致病情恶化，目前尚无批准的药物治疗方法。迫切需要新的有效疗法，可以打破这些患者过量粘液，炎症和感染的恶性循环。”。

ARINA-1 was well-tolerated in individuals with NCFBE with mucus symptoms. The most common treatment-related AEs (TRAEs) (event rates (95%CI)) in the ARINA-1 arm (n=29) were cough (0.3, 95%CI 0.1-0.5), dyspnea (0.2, 95%CI 0.1-0.4), and hemoptysis (0.1, 95%CI 0.0-0.3), which are all commonly associated with nebulized therapies and an underlying diagnosis of NCFBE..

ARINA-1在患有粘液症状的NCFBE患者中耐受性良好。ARINA-1组（n=29）中最常见的治疗相关不良事件（TRAEs）（事件发生率（95%CI））是咳嗽（0.3，95%CI 0.1-0.5），呼吸困难（0.2，95%CI 0.1-0.4）和咯血（0.1，95%CI 0.0-0.3），这些通常与雾化治疗和NCFBE的潜在诊断有关。。

Topline ITT efficacy results from the trial demonstrated that ARINA-1 improved quality of life in individuals with NCFBE at day 28. The mean change in SGRQ (MCID, -4) in the ARINA-1 arm from baseline to day 28 exceeded the MCID for the SGRQ in the total score (-8.5) and all three domains (symptoms, -9.6; activity, -8.5; impact, -7.9).

Topline ITT疗效试验结果表明，ARINA-1在第28天改善了NCFBE患者的生活质量。从基线到第28天，ARINA-1组SGRQ（MCID，-4）的平均变化超过了SGRQ总分（-8.5）和所有三个领域（症状，-9.6；活动，-8.5；影响，-7.9）的MCID。

This improvement persisted in the total score persisted to day 56 (-6.1), 28 days after stopping therapy. This demonstrates that ARINA-1 not only improved quality of life during treatment, but that it also had a durable effect in these patients after stopping ARINA-1. The placebo group did not achieve an MCID in the total score or any domain of the SGRQ at days 28 (total score, -2.6) or 56 (total score, -1.4).

停止治疗后28天，总分持续到第56天（-6.1）。这表明ARINA-1不仅改善了治疗期间的生活质量，而且在停止ARINA-1后对这些患者也有持久的作用。安慰剂组在第28天（总分，-2.6）或第56天（总分，-1.4）在SGRQ的总分或任何领域均未达到MCID。

Consistent with the SGRQ, the CAAT (MCID, -2), which is a validated assessment specific for mucus and cough symptoms, also demonstrated MCID improvements in mean change from baseline to day 28 (-3.7). The placebo group did not reach MCID for the CAAT questionnaire (day 28: -1.3)..

与SGRQ一致，CAAT（MCID，-2）是一种针对粘液和咳嗽症状的有效评估，也证明了MCID从基线到第28天的平均变化有所改善（-3.7）。安慰剂组没有达到CAAT问卷的MCID（第28天：-1.3）。。

The topline exploratory analysis of sputum data indicated that ARINA-1 demonstrated improved mucus viscosity and sputum neutrophil elastase (NE) compared to placebo. Further analyses on the mechanism of action and biomarker data are ongoing.

痰液数据的topline探索性分析表明，与安慰剂相比，ARINA-1表现出改善的粘液粘度和痰中性粒细胞弹性蛋白酶（NE）。正在进一步分析作用机制和生物标志物数据。

'ARINA-1’s novel mechanism improved quality of life and also improved mucus biomarkers in people with bronchiectasis,' said Carolyn Durham, PhD, Chief Scientific Officer of Renovion. ' The quality of life data confirms that improving mucus biomarkers, such as viscosity and NE, can reduce symptoms and also improve patient outcomes in this underserved patient population.

Renovion首席科学官卡罗琳·达勒姆博士说：“ARINA-1的新机制改善了支气管扩张症患者的生活质量，也改善了粘液生物标志物。”生活质量数据证实，改善粘液生物标志物，如粘度和NE，可以减轻症状，也可以改善这个服务不足的患者群体的患者预后。

These data provide a strong rationale for the continued development of ARINA-1 for NCFBE patients, as well as other populations that suffer from mucus symptoms. We look forward to further analyzing the data and discussing next steps with regulatory authorities.'.

这些数据为NCFBE患者以及其他患有粘液症状的人群继续开发ARINA-1提供了强有力的理由。我们期待着进一步分析数据，并与监管机构讨论下一步。”。

'These results show that ARINA-1 can have a profound benefit for patients. There are currently no approved therapies for bronchiectasis, and to see such a clear impact on symptom reduction with our benign safety profile positions ARINA-1 as an excellent first line therapy for patients. Better SGRQ scores are associated with better outcomes, and we believe that a similar benefit will be seen in chronic bronchitis patients via a study that is already underway, as well as in COPD and asthma patients with mucus,' stated Dan Copeland, CEO of Renovion.

“这些结果表明，ARINA-1可以为患者带来深远的益处。目前还没有批准的支气管扩张治疗方法，我们的良性安全性对减轻症状有如此明显的影响，因此ARINA-1是一种优秀的患者一线治疗方法。Renovion首席执行官丹·科普兰（DanCopeland）表示，更好的SGRQ评分与更好的结果相关，我们相信，通过一项正在进行的研究，慢性支气管炎患者以及患有粘液的COPD和哮喘患者也会获得类似的益处。

'Millions of patients with these diseases face the cycle of mucus, inflammation and infection, and we can change the course of disease for patients facing the daily challenges of mucus.'.

“数百万患有这些疾病的患者面临粘液，炎症和感染的循环，我们可以改变面临粘液日常挑战的患者的病程。”。

Renovion will discuss study results at the American Thoracic Society Meeting (May 17-22) and present findings at the World Bronchiectasis Conference (July 4-6) in Dundee, Scotland.

Renovion将在美国胸科学会会议（5月17日至22日）上讨论研究结果，并在苏格兰邓迪举行的世界支气管扩张会议（7月4日至6日）上介绍研究结果。

About CLIMB

关于爬升

CLIMB (RVN-301) was a randomized, double-blind, placebo-controlled, multi-center, US Phase 2 study to assess the safety, efficacy, and tolerability of ARINA-1 administered twice daily for 28 days in patients with non-cystic fibrosis bronchiectasis (NCFBE). CLIMB was conducted at 9 sites with 40 adult patients diagnosed with NCFBE who indicated that they had mucus symptoms at the time of screening.

CLIMB（RVN-301）是一项随机，双盲，安慰剂对照，多中心，美国2期研究，旨在评估ARINA-1在非囊性纤维化支气管扩张症（NCFBE）患者中每天两次给药28天的安全性，有效性和耐受性。在9个地点对40名被诊断患有NCFBE的成年患者进行了爬升，这些患者表明他们在筛查时有粘液症状。

Patients were randomized 7:3 to receive either ARINA-1 or matching placebo. The primary endpoint was safety at day 28. Secondary endpoints included quality of life measurements at days 28 and 56, and sputum viscosity and neutrophil elastase were measured at day 28..

患者以7:3的比例随机接受ARINA-1或匹配的安慰剂。主要终点是第28天的安全性。次要终点包括第28天和第56天的生活质量测量，第28天测量痰粘度和中性粒细胞弹性蛋白酶。。

About Non-Cystic Fibrosis Bronchiectasis (NCFBE)

关于非囊性纤维化支气管扩张症（NCFBE）

NCFBE is a severe, chronic inflammatory airways disease characterized by a chronic cycle of mucus, inflammation, and infection that causes permanent bronchial dilation. Most individuals with NCFBE experience severe and life-altering mucus symptoms including shortness of breath, productive and chronic cough, and daily activity impairment, as well as frequent exacerbations that require aggressive antibiotic therapy and / or hospitalization.

NCFBE是一种严重的慢性炎症性气道疾病，其特征是粘液，炎症和感染的慢性循环，导致永久性支气管扩张。大多数患有NCFBE的人会出现严重且改变生活的粘液症状，包括呼吸急促，生产性和慢性咳嗽，日常活动障碍，以及需要积极抗生素治疗和/或住院治疗的频繁恶化。

Individuals experience progressive health and clinical decline. To date, there are no approved treatments that directly target mucociliary clearance or mucus symptoms. There are approximately 500,000 individuals living with NCFBE in the US today..

个人经历了渐进的健康和临床衰退。迄今为止，尚未批准直接针对粘液纤毛清除或粘液症状的治疗方法。今天，美国约有500000人患有NCFBE。。

About Renovion, Inc.

关于Renovion，Inc。

Renovion is a clinical-stage pharmaceutical company focused on developing ARINA-1, novel nebulized therapy delivered to the lungs to treat pulmonary diseases. ARINA-1 clears mucus, reduces damaging inflammation, and has antibacterial properties that have been shown to restore lung health. Renovion is also conducting clinical trials for ARINA-1 for the prevention of Bronchiolitis Obliterans Syndrome (BOS) progression in lung transplant patients in an ongoing Phase 3 trial with a primary endpoint of FEV1 improvement compared to standard of care.

Renovion是一家临床阶段制药公司，专注于开发ARINA-1，一种新型雾化疗法，用于肺部治疗肺部疾病。ARINA-1清除粘液，减少破坏性炎症，并具有抗菌特性，已被证明可以恢复肺部健康。Renovion还正在进行ARINA-1的临床试验，以预防肺移植患者的闭塞性细支气管炎综合征（BOS）进展，这是一项正在进行的3期试验，与标准治疗相比，FEV1改善的主要终点。

Renovion is also conducting an investigational study in patients with chronic bronchitis. The Renovion team has in-depth experience in drug development with extensive scientific expertise in chronic pulmonary conditions and inflammation. For more information about Renovion, visit https://www.renovion.com/ or follow Renovion on LinkedIn (Renovion, Inc.) and Twitter (@RenovionInc)..

雷诺维翁还对慢性支气管炎患者进行了一项研究。Renovion团队在药物开发方面拥有丰富的经验，在慢性肺部疾病和炎症方面拥有广泛的科学专业知识。有关Renovion的更多信息，请访问https://www.renovion.com/或者在LinkedIn（Renovion，Inc.）和Twitter（@RenovionInc.）上关注Renovion。。