London & Research Triangle Park, N.C., June 16, 2021
ReViral Ltd., a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing novel antiviral therapeutics that target respiratory syncytial virus (RSV), today announced the successful completion of Part A of the phase 2 clinical study of sisunatovir for the treatment of RSV infections in hospitalized infants (REVIRAL1). REVIRAL1 is a global three-part adaptive study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, antiviral effects, and clinical effect of single and multiple oral doses of sisunatovir in otherwise healthy infants between the ages of 1 and 36 months hospitalized with RSV lower respiratory tract infections. Following a thorough review by the REVIRAL1 Data Safety Monitoring Committee, it was confirmed that sisunatovir demonstrated a favorable safety and PK exposure profile to advance to Part B, the double-blind, placebo-controlled stage of the study where patients will receive drug or placebo twice a day for five days.
“RSV remains a major cause of infant morbidity and mortality globally with healthcare costs approaching $40,000 for the most severe cases,” said Dr. Eddy Littler, ReViral’s Chief Operating Officer. “Given the lack of an effective treatment, an unmet medical need still exists for effective RSV therapies, and with the impressive clinical results obtained to date, we believe that sisunatovir could provide a safe and effective treatment option.”
"The completion of Part A represents a watershed moment for ReViral,” said Alex C. Sapir, CEO of ReViral. “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. It is a testament to our clinical team and to the high level of unmet need that exists in this patient population.”
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REVIRAL1 is a global three-part adaptive study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, antiviral effects, and clinical effect of single and multiple oral doses of sisunatovir in otherwise healthy infants between the ages of 1 and 36 months hospitalized with RSV lower respiratory tract complications. Part A is an open-label, single-dose stage of the study designed to evaluate safety and PK. The objective of Part B is to assess safety, tolerability, pharmacokinetics, and antiviral activity in the double-blind, placebo-controlled stage of the study where patients will receive drug or placebo (3:1 randomization) twice a day for five days. Part C is a randomized, double-blind, placebo-controlled stage of the study designed to assess safety, tolerability, pharmacokinetics, antiviral activity, and clinical improvement in patients randomized to one of three arms (placebo, low-dose sisunatovir, high-dose sisunatovir).
Sisunatovir is an orally administered fusion inhibitor designed to block RSV replication by inhibiting F-mediated fusion with the host cell. Sisunatovir was recently granted Fast Track designation by the U.S. Food and Drug Administration (FDA). Preclinical tests demonstrated sisunatovir to have a favorable safety profile with an attractive therapeutic index. In phase 1 clinical studies, sisunatovir achieved target exposure levels with no reported serious adverse events. In 2018, results from a phase 2a human challenge study in healthy adult volunteers infected with RSV were reported, in which sisunatovir produced statistically significant reductions in viral load and improvement in clinical symptoms. In addition to the REVIRAL1 study, ReViral has recently initiated a global phase 2 clinical study of sisunatovir in an adult stem-cell transplant population (REVIRAL2). In March 2021, ReViral announced a multimillion-dollar licensing deal with LianBio to develop and commercialize sisunatovir in mainland China, Hong Kong, Macau, and Singapore.
RSV is a respiratory pathogen that can lead to severe and life-threatening lower respiratory tract infections (LRTIs) in high-risk populations, such as infants, immunocompromised patients, and the elderly. Thus, RSV constitutes a substantial disease burden. The US-Based National Institute of Health (NIH) estimates that, globally, RSV affects approximately 64 million people and causes approximately 160,000 deaths each year. In addition, globally, there are an estimated 33 million cases of RSV LRTI each year in children younger than five years of age, with about 3 million of them being hospitalized and approximately 60,000 dying each year from complications associated with the infection. Currently, there are no effective therapeutic treatment options for patients who develop RSV infection.
ReViral is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing antiviral therapeutics, with an initial focus on treating respiratory syncytial virus (RSV). The company’s lead product candidate, sisunatovir, is an orally administered fusion inhibitor currently being evaluated in two global multicentre phase 2 clinical studies: one in a pediatric patient population (REVIRAL1) and the other in an adult stem-cell transplant patient population (REVIRAL2). The company also has an RSV N-protein replication inhibitor program currently undergoing IND-enabling studies.
For more information, please visit http://www.reviral.com