Pfizer Gets CDSCO Panel Nod to Study Sisunatovir in Adults With Respiratory Syncytial Virus Infection
New Delhi: The drug major Pfizer has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase 2/3 clinical trial of Sisunatovir IR tablets 100 mg.
This came after the drug major Pfizer presented Phase 2/3 clinical trial protocol No. C5241007. The purpose of this study is to learn about the safety and effects of sisunatovir. Sisunatovir is studied for the possible treatment of Respiratory Syncytial Virus (RSV). RSV is a virus that causes lung infections with cold-like symptoms, but it can cause severe illness in some people.
RSV infects the target cell via the attachment of G protein, followed by fusion of the virus and host cell membrane mediated by F protein, resulting in release of the genomic RNA into the cytoplasm.
Sisunatovir is an orally available, small molecule inhibitor of human respiratory syncytial virus (RSV) fusion protein (F protein), with potential antiviral activity. Upon oral administration, sisunatovir specifically targets and binds to RSV-F protein on the viral surface, which inhibits RSV-F protein-mediated fusion with the host cell membrane and prevents viral entry. This blocks RSV replication, reduces viral load, and decreases the severity of the disease. RSV-F protein, a viral surface glycoprotein, plays a key role in RSV fusion with and entry into target cells.
At the recent SEC meeting for antimicrobial and antiviral held on 21st February 2023, the expert panel reviewed the Phase 2/3 clinical trial protocol No. C5241007 presented by drug major Pfizer.
After detailed deliberation, the committee recommended the grant of permission to conduct the clinical trial as presented by the firm.
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