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” 。
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.