Vir Biotechnology, Inc. and Alnylam Pharmaceuticals, Inc. announced the initiation of a Phase 1/2 study of VIR-2218, a novel, investigational RNA interference (RNAi) therapeutic for the treatment of chronic hepatitis B virus (HBV) infection. The commencement of first-in-human dosing marks the first clinical use of Alnylam’s Enhanced Stabilization Chemistry-Plus (ESC+) GalNAc conjugate delivery platform and the start of Vir’s first global development program. VIR-2218 was originated by Alnylam as ALN-HBV02 and was licensed to Vir, which will conduct its clinical development.

"Almost one-third of the world's population have current or previous hepatitis B infection, which is the leading cause of liver disease and a tremendous burden to individuals and societies, yet only a fraction of people living with HBV are diagnosed or treated," said Ed Gane, M.D., Deputy Director and Hepatologist of the New Zealand Liver Transplant Unit at Auckland City Hospital and Clinical Professor of Medicine at the University of Auckland School of Medicine. "One of the biggest barriers is that current treatments do not cure the disease and must be taken lifelong. What we need is a new treatment that can cure HBV and remove the need for lifelong treatment. The initiation of clinical testing of this new treatment is an exciting step forward in the pursuit of a functional cure for this disease."

VIR-2218 is designed to inhibit expression of all HBV proteins, including hepatitis B surface antigen (HBsAg). Viral protein knockdown may help restore the patient’s own immune response to HBV, thereby offering people living with chronic HBV the potential for a functional cure. VIR-2218 is an investigational RNAi therapeutic that is administered via subcutaneous injection and designed to effectively silence all HBV RNA transcripts, which are necessary for viral replication and viral protein expression.

VIR-2218 is the first asset to enter clinical trials as part of the research collaboration between Vir and Alnylam announced last year to develop novel RNAi therapeutics for infectious diseases.

"The beginning of this study is an important moment for Vir, as it marks our transition to a clinical-stage company," said George A. Scangos, Ph.D., Chief Executive Officer of Vir. "It also has the potential to be an important step for those living with hepatitis B. Therapeutic options are limited, and we have the potential to transform the treatment of a chronic viral infection that now affects hundreds of millions worldwide and kills nearly a million people each year."

The Phase 1/2 trial of VIR-2218 is a randomized, placebo-controlled study designed to assess the safety, tolerability, pharmacokinetics, and antiviral activity of VIR-2218 in healthy volunteers and patients with chronic HBV infection. The companies plan to enroll patients at multiple study sites in several countries around the Pacific Rim. The trial will progress in a staggered, parallel fashion in order to rapidly generate early proof of concept data.

"We are delighted to have this trial underway as it represents the first clinical test of a development candidate using our Enhanced Stabilization Chemistry-Plus (ESC+) GaINAc conjugate technology, which improves target specificity," said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. "Vir’s expertise and laser focus on infectious disease make them the ideal partner for advancing RNAi therapeutics in this area where there is great unmet need and we look forward to seeing the data next year."

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