View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
June 17, 2021updated 12 Jul 2022 11:06am

ReViral to continue Phase II paediatric trial of sisunatovir for RSV 

On reviewing the data from Part A of the Phase II trial, DSMB recommended advancing to the next stage.

ReViral is set to start Part B of the Phase II REVIRAL1 clinical study of sisunatovir to treat respiratory syncytial virus (RSV) infections in hospitalised infants.

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

An oral fusion inhibitor, sisunatovir is made to prevent RSV replication by hindering F-mediated fusion with the host cell.

Sisunatovir showed a favourable safety profile with a good therapeutic index in preclinical trials.

The latest development comes after the company concluded Part A of the REVIRAL trial and the Data Safety Monitoring Committee (DSMB) recommendation continuation of the trial on reviewing the available data.

DSMB noted that that the drug showed promising safety and pharmacokinetic exposure profile to advance to Part B.

An international, three-part adaptive study, REVIRAL1 is assessing single and multiple doses of sisunatovir in infants aged between one and 36 months who are hospitalised with RSV lower respiratory tract infections.

The objective of the randomised, double-blind, placebo-controlled Part B of the study is to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of the drug.

The subjects will be categorised in a 3:1 ratio to receive sisunatovir or placebo twice daily for five days.

On concluding Part B, a double-blind, placebo-controlled Part C of the study will be initiated to analyse sisunatovir’s safety, tolerability, pharmacokinetics, antiviral activity, and clinical improvement.

ReViral CEO Alex Sapir said: “Despite the diminished RSV season over the past 18 months brought on by the coronavirus pandemic, we achieved two important goals established for this open-label stage of the study.

“First, we safely delivered sisunatovir to infants, and second, in doing so, we established a drug exposure profile that we can now take into the next phase of our study.”

ReViral entered a licencing deal with LianBio in March to develop and market sisunatovir in mainland China, Hong Kong, Macau and Singapore.

In a separate development, the Indian Defence Research and Development Organisation’s (DRDO) anti-Covid-19 drug, 2-DG, was found to be effective against all SARS-CoV-2 variants and even lowered virus replication in a new study.

Related Companies

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena