A Single-Center, Randomized, Partially Double-Blind, Placebo- and Active-Controlled, Four-period Crossover, Thorough QT/QTc (TQT) Clinical Study to Evaluate the Effects of Ziresovir on Cardiac Repolarization in Healthy Subjects

This is a single-center, randomized, partially double-blind, placebo and active-controlled, 4-period crossover design thorough QT/QTc (TQT) clinical study to evaluate the effects of ziresovir on cardiac repolarization in healthy subjects.

Start Date15 Sep 2024

Sponsor / Collaborator

Shanghai Ark Biopharmaceutical Co., Ltd.Startup

CTR20240557 / RecruitingPhase 3

一项在呼吸道合胞病毒感染的住院婴幼儿中评价多次口服AK0529的有效性、安全性、耐受性和抗病毒作用的随机、双盲、安慰剂对照的III期确认性研究

[Translation] A randomized, double-blind, placebo-controlled, Phase III confirmatory study to evaluate the efficacy, safety, tolerability, and antiviral effects of multiple oral doses of AK0529 in hospitalized infants and young children with respiratory syncytial virus infection

确认AK0529治疗在毛细支气管炎临床评分较基线的变化上优于安慰剂。评估AK0529抗病毒效力。

[Translation]

Confirm that AK0529 treatment is superior to placebo in the change from baseline in bronchiolitis clinical scores. Evaluate the antiviral efficacy of AK0529.

Start Date29 Feb 2024

Sponsor / Collaborator

Shanghai Ark Biopharmaceutical Co., Ltd.Startup

CTR20230657 / Active, not recruitingPhase 2

一项在呼吸道合胞病毒感染的成人住院受试者中评价多次口服AK0529肠溶胶囊药代动力学、安全性和疗效的随机、双盲、安慰剂对照研究

[Translation] A randomized, double-blind, placebo-controlled study to evaluate the pharmacokinetics, safety, and efficacy of multiple oral doses of AK0529 enteric-coated capsules in adult hospitalized subjects with respiratory syncytial virus infection

评估AK0529在RSV感染成人受试者中的抗病毒效力、评估AK0529在RSV感染成人受试者中的临床疗效、评估AK0529在RSV感染成人受试者中的安全性、评估 AK0529在RSV感染成人受试者中的PK特征、探索性评估发生AK0529耐药突变的情况

[Translation]

Evaluate the antiviral efficacy of AK0529 in adult subjects with RSV infection, evaluate the clinical efficacy of AK0529 in adult subjects with RSV infection, evaluate the safety of AK0529 in adult subjects with RSV infection, evaluate the PK characteristics of AK0529 in adult subjects with RSV infection, and explore the occurrence of AK0529 resistance mutations

Start Date19 Jul 2023

Sponsor / Collaborator

Shanghai Ark Biopharmaceutical Co., Ltd.Startup

100 Clinical Results associated with Ziresovir

100 Translational Medicine associated with Ziresovir

100 Patents (Medical) associated with Ziresovir

Literatures (Medical) associated with Ziresovir

26 Sep 2024·New England Journal of Medicine

Ziresovir in Hospitalized Infants with Respiratory Syncytial Virus Infection

Article

Author: Zhang, Hua ; Rito, Ki ; Zhong, Lili ; Shen, Zhaobo ; Yin, Yong ; Liu, Hanmin ; Deng, Li ; Chen, Qiang ; Wu, Yan ; Yang, Qiaozhi ; Zhao, Deyu ; Shang, Yunxiao ; Jiang, Wenhui ; Xu, Yongsheng ; Hao, Chuangli ; Nong, Guangmin ; Zhou, Wei ; Wang, Xiufang ; Zou, Gang ; Zou, Yingxue ; Chen, Yiping ; Li, Ling ; Yang, Yungang ; Lu, Xiaoxia ; Jia, Tan ; Ni, Xin ; Chen, Zhimin ; Zhang, Hailin ; Zhao, Shunying ; Ding, Rong ; Zhu, Xiaoping ; Huang, Dongming ; Cheng, Huanji ; Liu, Enmei ; Zheng, Yuejie ; Dong, Xiaoyan ; Wu, Jim Z. ; Shen, Tong

BACKGROUNDRespiratory syncytial virus (RSV) is a leading cause of severe illness in infants, with no effective treatment. Results of a phase 2 trial suggested that ziresovir may have efficacy in the treatment of infants hospitalized with RSV infection.METHODSIn a phase 3, multicenter, double-blind, randomized, placebo-controlled trial conducted in China, we enrolled participants 1 to 24 months of age who were hospitalized with RSV infection. Participants were randomly assigned, in a 2:1 ratio, to receive ziresovir (at a dose of 10 to 40 mg, according to body weight) or placebo, administered twice daily, for 5 days. The primary end point was the change from baseline to day 3 (defined as 48 hours after the first administration) in the Wang bronchiolitis clinical score (total scores range from 0 to 12, with higher scores indicating greater severity of signs and symptoms). The intention-to-treat population included all the participants with RSV-confirmed infection who received at least one dose of ziresovir or placebo; the safety population included all the participants who received at least one dose of ziresovir or placebo.RESULTSThe intention-to-treat population included 244 participants, and the safety population included 302. The reduction from baseline in the Wang bronchiolitis clinical score at day 3 was significantly greater with ziresovir than with placebo (-3.4 points [95% confidence interval {CI}, -3.7 to -3.1] vs. -2.7 points [95% CI, -3.1 to -2.2]; difference, -0.8 points [95% CI, -1.3 to -0.3]; P = 0.002). The reduction in the RSV viral load at day 5 was greater in the ziresovir group than in the placebo group (-2.5 vs. -1.9 log₁₀ copies per milliliter; difference, -0.6 log₁₀ copies per milliliter [95% CI, -1.1 to -0.2]). Improvements were observed in prespecified subgroups, including in participants with a baseline bronchiolitis score of at least 8 and in those 6 months of age or younger. The incidence of adverse events related to the drug or placebo was 16% with ziresovir and 13% with placebo. The most common adverse events that were assessed by the investigator as being related to the drug or placebo were diarrhea (in 4% and 2% of the participants, respectively), an elevated liver-enzyme level (in 3% and 3%, respectively), and rash (in 2% and 1%). Resistance-associated mutations were identified in 15 participants (9%) in the ziresovir group.CONCLUSIONSZiresovir treatment reduced signs and symptoms of bronchiolitis in infants and young children hospitalized with RSV infection. No safety concerns were identified. (Funded by Shanghai Ark Biopharmaceutical; AIRFLO ClinicalTrials.gov number, NCT04231968.).

01 Sep 2024·Reviews in Medical Virology

Systematic Review of the Efficacy and Safety of RSV‐Specific Monoclonal Antibodies and Antivirals in Development

Review

Author: Sevendal, Andrea T. K. ; Hurley, Siobhan ; Walker, Gregory J. ; Bartlett, Adam W. ; Rawlinson, William

ABSTRACTRespiratory syncytial virus (RSV) is a leading cause of acute respiratory infection amongst all ages, causing a significant global health burden. Preventative and therapeutic options for RSV infection have long been under development, and recently, several widely‐publicised vaccines targeting older adult and maternal populations have become available. Promising monoclonal antibody (mAb) and antiviral (AV) therapies are also progressing in clinical trials, with the prophylactic mAb nirsevimab recently approved for clinical use in infant populations. A systematic review on current progress in this area is lacking. We performed a systematic literature search (PubMed, Embase, Web of Science, ClinicalTrials.gov, EudraCT, ANZCTR—searched Nov 29th, 2023) to identify studies on all RSV‐specific mAbs and AV therapies that has undergone human clinical trials since year 2000. Data extraction focused on outcomes related to the therapeutic efficacy and safety of the intervention on trial, and all studies were graded against the OCEBM Levels of Evidence Table. Results from 59 studies were extracted, covering efficacy and safety data on six mAbs (motavizumab, motavizumab‐YTE, nirsevimab, ALX‐0171, suptavumab, clesrovimab) and 12 AV therapies (ALN‐RSV01, RSV604, presatovir, MDT‐637, lumicitabine, IFN‐α1b, rilematovir, enzaplatovir, AK0529, sisunatovir, PC786, EDP‐938). Of the mAbs reviewed, nirsevimab and clesrovimab hold considerable promise. The timeline for RSV‐specific AV availability is less advanced, although EDP‐938 and AK0529 have reported promising phase 2 efficacy and safety data. Moving forward, passive immunisation and treatment options for RSV infection will play a significant role in reducing the health burden of RSV, complementing recent advancements in vaccine development.Trial RegistrationPROSPERO registration: CRD42022376633

01 Jul 2023·Influenza and Other Respiratory Viruses

Safety and efficacy of AK0529 in respiratory syncytial virus‐infected infant patients: A phase 2 proof‐of‐concept trial

Article

Author: Bentur, Lea ; de Bruyne, Jessie ; Zou, Gang ; Tang, Swee‐Ping ; Chi, Hsin ; Wang, Jinn‐Li ; Su, Siew‐Choo ; Wu, Jim Z. ; Tai, Andrew ; Gu, Feng ; Huang, Li‐Min ; Goldbart, Aviv ; George, Shane ; DeVincenzo, John P. ; Chieng, Chae‐Hee ; Schibler, Andreas ; Karadag, Bulent ; Toovey, Stephen ; Huang, Yhu‐Chering ; Alabaz, Derya ; Huang, Yi‐Chuan

AbstractBackgroundRespiratory syncytial virus (RSV) infection is a cause of substantial morbidity and mortality in young children. There is currently no effective therapy available.MethodsThis was a Phase 2 study of the oral RSV fusion protein inhibitor AK0529 in infants aged 1–24 months, hospitalized with RSV infection. In Part 1, patients (n = 24) were randomized 2:1 to receive a single dose of AK0529 up to 4 mg/kg or placebo. In Part 2, patients (n = 48) were randomized 2:1 to receive AK0529 at 0.5, 1, or 2 mg/kg bid or placebo for 5 days. Sparse pharmacokinetic samples were assessed using population pharmacokinetics modelling. Safety, tolerability, viral load, and respiratory signs and symptoms were assessed daily during treatment.ResultsNo safety or tolerability signals were detected for AK0529: grade ≥3 treatment‐emergent adverse events occurring in 4.1% of patients in AK0529 and 4.2% in placebo groups, respectively, and none led to death or withdrawal from the study. In Part 2, targeted drug exposure was reached with 2 mg/kg bid. A numerically greater reduction in median viral load with 2 mg/kg bid AK0529 than with placebo at 96 h was observed. A −4.0 (95% CI: −4.51, −2.03) median reduction in Wang Respiratory Score from baseline to 96 h was observed in the 2 mg/kg group compared with −2.0 (95% CI: −3.42, −1.82) in the placebo group.ConclusionsAK0529 was well tolerated in hospitalized RSV‐infected infant patients. Treatment with AK0529 2 mg/kg bid was observed to reduce viral load and Wang Respiratory Score.Clinical Trials RegistrationNCT02654171.

News (Medical) associated with Ziresovir

27 Sep 2024

·www.drugs.com

Ziresovir Reduces Signs, Symptoms of Bronchiolitis in Babies With RSV

FRIDAY, Sept. 27, 2024 -- For infants and young children hospitalized with respiratory syncytial virus (RSV) infection, ziresovir reduces signs and symptoms of bronchiolitis, according to a study published in the Sept. 26 issue of the New England Journal of Medicine . Shunying Zhao, M.D., Ph.D., from Beijing Children's Hospital, and colleagues enrolled participants aged 1 to 24 months of age who were hospitalized with RSV infection in a phase 3, multicenter trial. Participants were randomly assigned to receive ziresovir (10 to 40 mg according to body weight) or placebo, administered twice daily for five days in a 2:1 ratio. A total of 244 participants were included in the intention-to-treat population, and the safety population included 302 participants. The researchers observed a significantly greater reduction from baseline in the Wang bronchiolitis clinical score at day 3 with ziresovir than with placebo (−3.4 versus −2.7 points). At day 5, the reduction in the RSV viral load was greater in the ziresovir group than the placebo group (−2.5 versus −1.9 log 10 copies/mL). Prespecified subgroups, including those with a baseline bronchiolitis score of at least 8 and those aged 6 months or younger, showed improvements. The incidence rates of adverse events related to the drug or placebo were 16 and 13 percent, respectively. "Ziresovir treatment in infants and young children who were hospitalized with RSV infection resulted in a significantly greater resolution of signs and symptoms associated with RSV infection as well as greater decrease in the viral load than placebo," the authors write. The study was funded by Shanghai Ark Biopharmaceutical, which is developing ziresovir.

Phase 3Clinical Result

07 Oct 2022

·www.fiercebiotech.com

With China filing in its sights, ArkBio shares more phase 3 data on ex-Roche antiviral in RSV

In April, ArkBio outlined plans to file for approval in China around the middle of the year. Ark Biopharmaceutical has shared a closer look at the data it hopes will secure approval of its antiviral ziresovir in the treatment of respiratory syncytial virus (RSV), linking the candidate to significantly shorter intensive care stays and reduced wheezing in the months after treatment. Shanghai-based ArkBio entered the RSV race in 2014 by striking a deal for ziresovir, a RSV fusion inhibitor that was discovered by Roche. The biotech guided the candidate through early and mid-phase trials, leading to the delivery of top-line data from a pivotal study in April. The data drop revealed the phase 3 trial of 311 infants hospitalized with RSV infection hit its primary endpoint, plus a secondary endpoint. ArkBio recently repeated the top-line data at the International RSV Symposium, where it also revealed some figures that were excluded from its original release. The new data covers endpoints that could be important from payer and quality of life perspectives. On the payer front, ArkBio now has evidence that ziresovir reduces the duration of expensive stays in ICUs. Among participants admitted to ICU, the average stay in the ziresovir arm was three days, compared to eight days in the placebo cohort. Linking ziresovir to shorter ICU stays could help ArkBio as it tries to show the pharmacoeconomic value of the therapy to payers and healthcare systems. The latest ArkBio release lacks data on other endpoints with pharmacoeconomic importance. ArkBio originally listed frequency of ICU admission and length of hospital stay as secondary endpoints, although it deleted the latter measure from the ClinicalTrials.gov listing two months after completing the study. The latest release lacks data on either measure. The other new efficacy result reported in the latest release covers the follow-up data that are now available. Over the follow-up period, the rate of wheezing was lower in a subpopulation of children aged under six months who took ziresovir in comparison to their peers on placebo. The difference, 9.0% versus 26.3%, was statistically significant. Wheezing isn’t listed as an endpoint on ClinicalTrials.gov. Upon releasing the top-line data in April, ArkBio outlined plans to file for approval in China around the middle of the year. The latest release lacks an update on the regulatory submission plan.

05 Oct 2015

·www.biospace.com

Ark Biosciences Completes Phase I Trial Of Antivirus Drug

Ark Biosciences, a Shanghai biotech developing proprietary therapeutics for respiratory viral diseases and viral hepatitis, successfully completed a phase I clinical trial of its anti-respiratory syncytial virus (RSV) drug AK0529. The trial is a randomized, double-blind, placebo-controlled study of orally administered AK0529 that evaluates safety, tolerability, and pharmacokinetics of single ascending doses and multiple ascending doses. Ark had completed a Series A round led by Qiming and Morningside in April 2015 to help fund the advancement of AK0529.

100 Deals associated with Ziresovir

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Respiratory Syncytial Virus Infections	NDA/BLA	CN	Shanghai Ark Biopharmaceutical Co., Ltd.Startup	08 Dec 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04231968 (AIRFLO, Literature) Manual	Phase 3	Respiratory Syncytial Virus Infections	302	Ziresovir	sydnyexcpf(sbbjasmkat) = uknvxsqeqo hxiohvrfnc (svpxejfvgj, −3.7 - −3.1) View more	Positive	25 Sep 2024
				Placebo	sydnyexcpf(sbbjasmkat) = ebhmbwhxlf hxiohvrfnc (svpxejfvgj, −3.1 - −2.2) View more

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