Pfizer Launches Phase 2/3 Clinical Trial in China for Sisunatovir, a Novel Oral RSV Antiviral Acquired for Over $500 Million

Jan 23, 2024 15:44 CST Updated 15:44

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On January 22, the official website of the Chinese Drug Clinical Trial Registration and Information Disclosure Platform announced,Pfizer has launched an international multi-center (including China) Phase 2/3 clinical study aimed at determiningResearch drug SisunatovirWhether or notSafety Prevention of Adult Respiratory Syncytial Virus（RSV）Infected individuals progress to severe cases。Public information shows that sisunatovir isANovel Antiviral Therapies Targeting RSV, Pfizer previously acquired ReViral for up to $525 million, thereby obtaining this product.

Screenshot source:China Drug Clinical Trial Registration and Information Disclosure Platform Official Website

RSV is a common and contagious virus that can lead to potentially severe respiratory diseases. After RSV infection, the elderly population faces a high risk of severe illness, partly due to age-related immune decline. Elderly individuals with underlying conditions (such as respiratory and heart diseases, diabetes) are at an even greater risk of developing serious illnesses. RSV can also exacerbate other diseases, including chronic obstructive pulmonary disease (COPD), asthma, and chronic heart failure, and may result in severe complications such as pneumonia, hospitalization, and death.

Sisunatovir (PF-07923568) was originally developed by ReViral.An oral fusion inhibitor designed to block RSV replication by inhibiting the fusion of the virus with host cells mediated by the F protein.. The results of the Phase 2 RSV human challenge trial conducted in a population of healthy adult volunteers showed that sisunatovirCan significantly reduce viral loadPreviously, the product had been granted Fast Track designation by the U.S. FDA.

In April 2022, Pfizer announced a definitive agreement with ReViral for up to $525 million.Acquisition Agreement，Thereby obtaining sisunatovir. In December 2022, Pfizer announced that it wouldExercise of Option，LianBio Obtains Development and Commercialization Rights for Sisunatovir in Mainland China, Hong Kong, Macau, and Singapore(The rights for this region were previously granted to LianBio by ReViral in March 2021.) Under this agreement, LianBio will receive an upfront payment totaling $20 million and is eligible for potential development and commercial milestone payments of up to $135 million.

This is an adaptive design, multicenter, randomized, double-blind, interventional Phase 2/3 study initiated by Pfizer, with the aim of exploringWith AnCompared with placebo, oralsisunatovirInRespiratory Syncytial InfectionAdults with symptomatic non-hospitalized infections and at risk of progressing to severe diseaseEfficacy and Safety in China. The principal investigator of this study is from the China-Japan Friendship Hospital.Professor Cao Bin, planning to enroll 408 people in China and 2715 people internationally.

In addition to targeting RSV infections in adults, Pfizer is also developingsisunatovir is used for the treatment of RSV infection in infants and young children.According toClinicalTrialsAccording to the official website, Pfizer is conducting a Phase 2 clinical study to evaluatesisunatovir TherapyInfants and toddlers aged 1 month to 36 months hospitalized for RSV lower respiratory tract infectionSafety and effectiveness.

References:

[1] Official Website of China Drug Clinical Trial Registration and Information Disclosure Platform. Retrieved Jan 22, 2024, from http://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml

[2]Pfizer to Acquire ReViral and Its Respiratory Syncytial Virus Therapeutic Candidates. Retrieved April 7, 2022, from https://www.businesswire.com/news/home/20220407005230/en

[3] Pfizer to Lead the Development and Commercialization Rights of LianBio's Respiratory Syncytial Virus Treatment Candidate Sisunatovir in Mainland China, Hong Kong, Macao, and Singapore. Retrieved Dec 19, 2022. From https://mp.weixin.qq.com/s/8BKlN_B-yDy7mlbu70HkNQ

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