Vir Biotechnology, Inc. (Nasdaq: VIR) has received a positive opinion from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) for its application for orphan drug designation for tobevibart and elebsiran in the treatment of chronic hepatitis delta (CHD). This designation is based on promising initial data from the Phase 2 SOLSTICE trial, marking a significant step forward in addressing this rare and challenging liver disease. The company will present 24-week data from the Phase 2 SOLSTICE trial at AASLD The Liver Meeting® in San Diego, CA, on November 18.
Clinical Significance of Orphan Drug Designation
Orphan drug designation is intended to encourage the development of new treatments for rare diseases. It provides several benefits, including market exclusivity upon approval, which can help incentivize pharmaceutical companies to invest in developing therapies for conditions that affect smaller patient populations. According to Vir Biotechnology, the designation underscores the potential of tobevibart and elebsiran to address the unmet needs in CHD treatment.
"Orphan drug designation further validates the clinical relevance of chronic hepatitis delta, highlighting ongoing efforts to develop potentially meaningful treatment options that are urgently needed," said Carey Izquierdo, MD, Executive Vice President and Chief Medical Officer at Vir Biotechnology. “The EMA’s positive opinion will help accelerate and streamline regulatory pathways for potential therapies, ultimately benefiting patients affected by this serious liver condition.”
About Tobevibart
Tobevibart is a monoclonal antibody designed to enhance the immune response and directly neutralize hepatitis B virus (HBV) and hepatitis D virus (HDV). It is being investigated for its potential to provide both therapeutic and prophylactic benefits. The investigational profile includes blocking entry of hepatocytes with undetectable HBsAg levels, as well as reducing/clearing HBsAg levels. Monoclonal antibody engineering incorporates Fc modifications for half-life extension (LS modification) and, in some constructs, enhanced NK cell activity (EF modification).
About Elebsiran
Elebsiran is an investigational siRNA therapeutic designed to inhibit the production of all hepatitis B virus (HBV) proteins, including hepatitis B surface antigen (HBsAg). Silencing HBsAg has the potential to restore immune control over HBV and is being investigated as a potential curative therapy for chronic HBV infection. Elebsiran leverages Alnylam’s Enhanced Stabilization Chemistry (ESC) GalNAc-conjugate delivery platform, which may allow for infrequent subcutaneous dosing.
About Hepatitis Delta
Hepatitis Delta is an infection that causes liver inflammation, scarring, and hepatocellular carcinoma. It is estimated to affect 5% of the global population of people with chronic hepatitis B infection. Hepatitis D can only occur in the presence of hepatitis B infection, and co-infection with hepatitis D can accelerate the progression of liver disease. Hepatitis D is the most severe form of viral hepatitis because it causes liver disease to progress more quickly than hepatitis B alone. Hepatitis D is underdiagnosed and undertreated, and new treatment options are needed to improve outcomes for patients with this disease.
About Vir Biotechnology
Vir Biotechnology is a commercial-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Current programs include those targeting hepatitis B virus, hepatitis D virus, influenza A, and human immunodeficiency virus.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “plan,” “potential,” “intend,” “expect,” “anticipate,” “estimate,” “believe,” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir Biotechnology’s expectations and assumptions as of the date of this press release. Each forward-looking statement involves risks and uncertainties. Actual results may differ materially from those expressed or implied in these forward-looking statements. Among the factors that may cause differences are: unexpected results of clinical trials and preclinical studies; reliance on third parties, including clinical investigators and contract research organizations; regulatory review and approval processes; market competition; and other risks detailed in Vir Biotechnology’s filings with the U.S. Securities and Exchange Commission. Vir Biotechnology assumes no obligation to update any forward-looking statements contained herein to reflect events or circumstances occurring after the date of this press release, regardless of whether new information becomes available.
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