Vir : Two HBV Therapies Results Show Positive Safety Profiles And Reduction In HBsAg

(RTTNews) - Vir Biotechnology Inc. (VIR) announced new data from its ongoing Phase 2 clinical trials of VIR-2218 and ongoing Phase 1 studies of VIR-3434 in patients with chronic hepatitis B virus or HBV infection. The results demonstrate positive safety findings plus a reduction in hepatitis B surface antigen or HBsAg for both compounds.

The data demonstrated the promising safety profile and potential durable response of VIR-2218, an investigational small interfering ribonucleic acid (siRNA) that mediates RNA interference (RNAi), through 48 weeks.

In a separate analysis evaluating VIR-2218 in combination with pegylated interferon alfa (PEG-IFN-a) for 12 weeks, a more rapid and substantial HBsAg decline was observed in the co-administration cohort compared to VIR-2218 alone. The treatment regimen resulted in no new safety signals.

In addition, two new analyses from an ongoing Phase 1 trial of VIR-3434 showed no safety signals in healthy volunteers dosed with up to 3,000 mg, and a rapid reduction in HBsAg levels one week after subcutaneous administration of this investigational HBV-neutralizing monoclonal antibody, which has been Fc engineered to include the XX2 "vaccinal mutation," allowing it to potentially function as a T cell vaccine.

Phil Pang, Vir's chief medical officer, said the monotherapy results for VIR-3434 support his belief that the combination of VIR-3434 and VIR-2218 has significant potential. That combination trial is expected to start in the second half of this year.