愛科百發(fā)，一家致力于為全球市場開發(fā)治療病毒感染和呼吸系統(tǒng)疾病創(chuàng)新藥物的生物醫(yī)藥公司，日前宣布其抗呼吸道合胞病毒（RSV）新藥Ziresovir完成國際II期臨床概念驗證試驗并取得突破性成果。

在這項簡稱“VICTOR（ViralInhibition in Children for Treatment of RSV）”的II期國際多中心臨床研究中，Ziresovir顯示出顯著的劑量依賴性臨床療效，并且能夠同時降低患者的臨床癥狀評分和病毒載量。在該項隨機、雙盲、安慰劑對照的II期臨床試驗中，與安慰劑相比，Ziresovir通過單劑量和多劑量給藥均可顯著減輕患者的臨床癥狀，且顯示出優(yōu)異的抗病毒效果。

愛科百發(fā)首席醫(yī)學官Stephen Toovey博士評論說：“每年被RSV感染的數(shù)百萬嬰幼兒和老年人病人中存在巨大的醫(yī)藥治療需求。在已完成的II期VICTOR臨床研究中，我們證實了抗RSV病毒藥物Ziresovir具有顯著的劑量依賴性臨床療效。它同時降低患者的癥狀評分和病毒載量” 。

愛科百發(fā)CEO鄔征博士評論道：“我們在開發(fā)Ziresovir作為一線抗RSV病毒治療藥物以滿足眾多感染患者需求的過程中、特別是在住院嬰幼兒患者中，取得了重大進展。隨著Ziresovir相關臨床研究的順利推進，愛科百發(fā)旨在成為抗RSV藥物研發(fā)領域的行業(yè)引領者，并希冀開發(fā)出人類首個抗RSV新藥以滿足這一巨大的醫(yī)療需求”。

作為一種新型的RSV融合蛋白抑制劑，Ziresovir已完成多項臨床試驗，包括兩項分別在澳大利亞和中國健康成人志愿者中開展I期臨床研究以及一項在英國開展的I期人體質(zhì)量平衡臨床研究。Ziresovir進一步延續(xù)了此前多項I期臨床研究中觀察到的出色藥物安全性，未發(fā)生與藥物相關的嚴重不良事件，值得關注的安全性特征事件或因不良事件而導致的藥物劑量調(diào)整與研究退出。在血液學、血液生化、心電圖和生命體征等方面也均沒有和藥物相關的異常變化。詳細II期臨床數(shù)據(jù)將發(fā)表在國際醫(yī)學雜志和國際醫(yī)學會議報告?；诖肆钊斯奈璧腎I期臨床研究結果，愛科百發(fā)將開展用于藥物上市注冊申請的III期臨床試驗。

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.