ReViral secures FDA fast track status for sisunatovir to treat severe RSV infection

Clinical-stage biopharmaceutical company ReViral has secured fast track designation from the US Food and Drug Administration (FDA) for its sisunatovir to treat patients with serious respiratory syncytial virus (RSV) infection.

Sisunatovir is an orally administered fusion inhibitor designed to inhibit RSV replication by suppressing RSV F-mediated fusion of RSV with the host cell.

RSV is a respiratory pathogen that may cause severe lower respiratory tract infections (LRTIs) in high-risk populations such as infants, immunocompromised patients, and older people.

Sisunatovir is currently being evaluated in two international multicentre Phase 2 clinical studies in paediatric and high-risk adult patient populations.

According to the company, the preclinical tests demonstrated sisunatovir to have a better toxicity profile with a fine therapeutic index.

Sisunatovir demonstrated better exposure with no serious adverse events in phase I clinical studies, said the company.

In 2018, sisunatovir generated statistically significant reductions in viral load and clinical symptoms in a phase 2a challenge study in healthy adult volunteers.

ReViral CEO Alex Sapir said: “We are very pleased that sisunatovir has received Fast Track designation for the treatment of serious RSV, a significant global health concern.

“RSV affects approximately 64 million people and causes approximately 160,000 deaths each year. We look forward to working closely with the FDA throughout the clinical development of this program with the goal of bringing a potentially life-saving treatment to patients as quickly as possible.”

ReViral is engaged in the discovery, development and commercialisation of antiviral therapeutics. The company also has an N-protein inhibitor programme, which is in late preclinical development.

In July, Pfizer and Biopharmaceutical New Technologies (BioNTech) have secured fast track designation from the US Food and Drug Administration (FDA) for two investigational mRNA-based vaccine candidates against SARS-CoV-2, the novel coronavirus responsible for the Covid-19 disease.