FDA Grants Fast Track Designation to VIR Biotechnology

Vir Biotechnology, Inc. (NASDAQ: VIR) has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application and has been granted fast track designation for the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta infection. This news comes after the company announced preliminary phase 2 trial data, which suggested that treatment with tobevibart alone or in combination with elebsiran was generally well tolerated and achieved high rates of virologic response at weeks 12 and 24, durable virologic response through 48 weeks, and high rates of ALT normalization.

The FDA's fast track designation is intended to facilitate the development and expedite the review of drugs to treat serious conditions and meet an unmet medical need. It underscores the potential of tobevibart and elebsiran to transform the treatment landscape for people living with chronic hepatitis delta. The World Health Organization considers hepatitis delta to be the most severe form of chronic viral hepatitis due to its more rapid progression towards liver cancer and liver-related death. It is estimated that at least 12 million people are living with chronic hepatitis delta globally.

The company's phase 2 Solstice trial (NCT05461170) is evaluating the safety, tolerability, and efficacy of tobevibart and elebsiran for the treatment of people living with chronic hepatitis delta. The trial has two cohorts, with one evaluating the combination of tobevibart and elebsiran dosed every 4 weeks and the other evaluating tobevibart monotherapy every 2 weeks. Approximately 50% of participants have compensated cirrhosis.

Tobevibart, an investigational subcutaneously administered antibody, is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes, neutralize both viruses, and reduce the level of virions and subviral particles in the blood. Elebsiran, on the other hand, is an investigational subcutaneously administered hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen.

Vir Biotechnology, Inc. is an immunology company focused on powering the immune system to transform lives by treating and preventing infectious diseases and other serious conditions, including viral-associated diseases. Its current clinical development pipeline consists of product candidates targeting hepatitis delta and hepatitis B viruses, and human immunodeficiency virus. Additionally, the company has several preclinical candidates in its pipeline targeting influenza A and B, COVID-19, RSV/MPV, and HPV. Following these announcements, the company's shares moved -1.6%, and are now trading at a price of $9.07. For the full picture, make sure to review Vir Biotechnology's 8-K report.

The above analysis is intended for educational purposes only and was performed on the basis of publicly available data. It is not to be construed as a recommendation to buy or sell any security. Any buy, sell, or other recommendations mentioned in the article are direct quotations of consensus recommendations from the analysts covering the stock, and do not represent the opinions of Market Inference or its writers. Past performance, accounting data, and inferences about market position and corporate valuation are not reliable indicators of future price movements. Market Inference does not provide financial advice. Investors should conduct their own review and analysis of any company of interest before making an investment decision.