(RTTNews.com) - Vir Biotechnology, Inc. and Alnylam Pharmaceuticals, Inc. ( ALNY ) said Monday that they have initiated a Phase 1/2 study of VIR-2218, a novel, investigational RNA interference or RNAi therapeutic for the treatment of chronic hepatitis B virus or HBV infection.
The commencement of first-in-human dosing marks the first clinical use of Alnylam's Enhanced Stabilization Chemistry-Plus or ESC+ GalNAc conjugate delivery platform and the start of Vir's first global development program. Vir Biotechnology noted that the trial marks its transition to a clinical-stage company.
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 was originated by Alnylam as ALN-HBV02 and was licensed to Vir, which will conduct its clinical development.
Ed Gane, 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 said, "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."
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.
The two companies noted that VIR-2218 is designed to inhibit expression of all HBV proteins, including hepatitis B surface antigen or 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.
According to Vir and Alnylam, VIR-2218 is the first asset to enter clinical trials as part of the research collaboration between the two companies announced last year to develop novel RNAi therapeutics for infectious diseases.
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