BRII-B(02137)The latest data from the ongoing 2nd phase of the ENSURE study has been released in the form of an oral presentation.

BRII-B(02137) announced that at the annual meeting of the American Association for the Study of Liver Diseases (AASLD) held in San Diego, California, USA from November 15th to 19th, the company presented the latest data from its ongoing Phase 2 ENSURE study in the form of a breakthrough oral presentation. ENSURE is a positive control, randomized, Phase 2 study designed to evaluate the effects of experimental small interfering ribonucleic acid (siRNA) elebsiran (BRII-835, VIR-2218) in combination with pegylated interferon alpha (PEG-IFN) on chronic hepatitis B virus (HBV) infected individuals with a baseline of hepatitis B surface antigen (HBsAg) between 100-3,000 IU/mL. The study excluded HBV patients with lower baseline levels (<100 IU/mL) of HBsAg to investigate the potential efficacy in a broader patient population. Data at the 48-week End of Treatment (EOT) showed that at the end of treatment, 26.3% (5/19) or 33.3% (6/18) of participants receiving 200 mg or 100 mg elebsiran in combination with PEG-IFN achieved HBsAg serum clearance, compared to only 5.6% (1/18) of participants receiving PEG-IFN monotherapy. Professor Jia Jidong, Director of the Hepatology Center at Beijing Friendship Hospital, Capital Medical University, stated, "The EOT data from the ENSURE study is very clear. Previous studies have shown that siRNA in combination with PEG-IFN is one of the most promising therapies to achieve a higher HBsAg serum clearance. The ENSURE study provides evidence for the first time of the role of siRNA in achieving functional cure on the basis of existing PEG-IFN therapy. We believe elebsiran has the potential to have a significant impact on increasing functional cure rates for HBV." Dr. David Margolis, Chief Medical Officer of the company, stated, "This trial data is very encouraging and will continue to support our goal of developing a functional cure therapy for chronic HBV in the target population. These results highlight the potential of elebsiran as a core component of the combination therapy being evaluated in multiple ongoing clinical studies. We look forward to combining elebsiran with other therapies through ongoing Phase 2 studies to provide a higher functional cure rate for the 254 million chronic HBV infected individuals worldwide." As part of the company's development of unique approaches to HBV functional cure, the company and its partners are actively advancing multiple combination studies of our differentiated product portfolio, including elebsiran, the investigational broad-spectrum monoclonal antibody against HBV tobevibart, and recombinant protein HBV immunotherapy drug BRII-179. Key data will be shared at scientific conferences in 2025.