爱科百发，一家致力于为全球市场开发治疗病毒感染和呼吸系统疾病创新药物的生物医药公司，日前宣布其抗呼吸道合胞病毒（RSV）新药Ziresovir完成国际II期临床概念验证试验并取得突破性成果。
在这项简称“VICTOR（ViralInhibition in Children for Treatment of RSV）”的II期国际多中心临床研究中，Ziresovir显示出显著的剂量依赖性临床疗效，并且能够同时降低患者的临床症状评分和病毒载量。在该项随机、双盲、安慰剂对照的II期临床试验中，与安慰剂相比，Ziresovir通过单剂量和多剂量给药均可显著减轻患者的临床症状，且显示出优异的抗病毒效果。
爱科百发首席医学官Stephen Toovey博士评论说：“每年被RSV感染的数百万婴幼儿和老年人病人中存在巨大的医药治疗需求。在已完成的II期VICTOR临床研究中，我们证实了抗RSV病毒药物Ziresovir具有显著的剂量依赖性临床疗效。它同时降低患者的症状评分和病毒载量” 。
爱科百发CEO邬征博士评论道：“我们在开发Ziresovir作为一线抗RSV病毒治疗药物以满足众多感染患者需求的过程中、特别是在住院婴幼儿患者中，取得了重大进展。随着Ziresovir相关临床研究的顺利推进，爱科百发旨在成为抗RSV药物研发领域的行业引领者，并希冀开发出人类首个抗RSV新药以满足这一巨大的医疗需求”。
作为一种新型的RSV融合蛋白抑制剂，Ziresovir已完成多项临床试验，包括两项分别在澳大利亚和中国健康成人志愿者中开展I期临床研究以及一项在英国开展的I期人体质量平衡临床研究。Ziresovir进一步延续了此前多项I期临床研究中观察到的出色药物安全性，未发生与药物相关的严重不良事件，值得关注的安全性特征事件或因不良事件而导致的药物剂量调整与研究退出。在血液学、血液生化、心电图和生命体征等方面也均没有和药物相关的异常变化。详细II期临床数据将发表在国际医学杂志和国际医学会议报告。基于此令人鼓舞的II期临床研究结果，爱科百发将开展用于药物上市注册申请的III期临床试验。
Ark Biosciences, a global biotech company developing innovative therapeutics for viral infection and respiratory diseases, announced positive topline results of its Phase II proof-of-concept study of Ziresovir (AK0529).
For the first time ever, an antiviral agent has proven successful in treating infants hospitalized with Respiratory Syncytial Virus (RSV) infection. In the successfully completed phase II VICTOR(Viral Inhibition in Children for Treatment of RSV) study for the treatment of infants hospitalized with RSV infection, Ziresovir, Ark Bioscience´s proprietary antiviral, demonstrated a clear dose-dependent clinical efficacy. It reduced patients’ signs and symptoms scores and concomitantly viral loads.
Dr Stephen Toovey, MD PhD, Chief Medical Officer of Ark Biosciences, said, “There is an enormous need for an efficacious medication to treat the millions of pediatric and elderly patients who suffer RSV infection every year. In the completed phase II VICTOR study for the treatment of infants hospitalized with RSV infection, this is the first time that an antiviral agent has shown clinical benefit for these RSV infected patients. Ziresovir clearly demonstrated dose-dependent clinical efficacy and clearly reduced viral loads in treated patients”.
Dr Jim Wu, CEO of Ark Biosciences, commented， "We have made great progress in the clinical development of Ziresovir as first-line antiviral therapy for the treatment of RSV infected patients, especially in hospitalized infants. With the development of Ziresovir, Ark aims to be the industry leader in anti-RSV drug development, and to develop the first-in-disease anti-RSV drug to satisfy the extremely large unmet medical need posed by RSV infection".
The study, “A Randomized, Double-blind, Placebo-controlled, 2-Part Study of Orally Administered AK0529 (Ziresovir) to Evaluate the Safety, To lerability, Pharmacokinetics and Antiviral Effect of Single and Multiple Dosing in Hospitalized Infants with Respiratory Syncytial Virus Infection”, demonstrated significant clinical benefits and efficacy inreducing signs and symptoms, in both single and multiple doses. It also demonstrated a significant antiviral effect compared to placebo. This study further confirmed Ziresovir’s excellent drug safety profile from Phase I studies, with no drug related SAEs, no AEs of concern and no particular AE pattern. There were also no concerns raised with hematology, clinicalchemistry, ECGs and vital signs. The detailed clinical results will be published and reported at medical conferences in due course. As a result of this positive Proof of Concept study, Ark Biosciences is pleased to announce that it is proceeding with Phase III registration trials.
Ark Bioscience´s anti-RSV drug Ziresovir, a novel RSV F-protein inhibitor, has completed multiple clinical studies with the molecule, including two phase I clinical studies in healthy adult volunteers in Australia and China respectively, and one phase I human mass balance study in the United Kingdom.
