- Vir Biotechnology on Wednesday said use of its lead experimental drug, when added to antiviral therapies, reduced levels of a biomarker that identifies hepatitis B patients.
- Higher doses of the drug, called VIR-2218, led to greater lowering of the biomarker in a Phase 2 trial, raising hopes that it could help patients achieve a functional cure without needing chronic treatment. The company is planning a trial that will add the commonly used antiviral treatment interferon to VIR-2218 to create a functional cure for hepatitis B virus, or HBV, which could provide a path to regulatory approval.
- Vir has been thrust into the spotlight for technology that could hold potential as a treatment for the new coronavirus, SARS-CoV-2. However, VIR-2218 was the lead asset Vir was initially built to develop, having been in-licensed from Alnylam Pharmaceuticals.
Vir's short corporate life has been a busy one.
Former Biogen CEO George Scangos joined as company chief in 2017, progressing development of immune-focused drug platforms, in-licensing experimental compounds and leading the company through a public stock listing. And all of that was before the company became a sought-after partner as the coronavirus pandemic spread.
VIR-2218 was a major selling point in that initial public offering in 2019, as it was already in Phase 2 trials.
"I don’t want anyone to feel like we've focused on COVID and feel like we're not focused also on HBV," Scangos said in a company call Wednesday. "The need for better therapies in HBV is unquestioned: 290 million people living with HBV and 900,000 a year dying from HBV-associated complications."
The data released Wednesday was from a trial to identify an optimal dose of the drug, which targets and blocks a portion of the hepatitis B genome that produces a protein called a surface antigen. This antigen blocks the action of immune cells against the hepatitis B virus.
The Phase 2 trial included 32 patients who already had achieved viral suppression taking a type of drug called a nucleoside reverse transcriptase inhibitor. The 24 patients given VIR-2218 all saw a greater reduction in the HBV surface antigen than the eight patients given a placebo, with a steadily increasing amount of suppression as the doses increased from 20 to 200 milligrams.
Patients taking VIR-2218 reported more frequent headaches than patients taking placebo. The only major adverse event was that of a patient taking VIR-2218 and an HIV antiviral called Viread, who was hospitalized with hypophosphatemia, a known side effect of Viread.
The company is planning a combination approach in hepatitis B, first studying VIR-2218 with a shortened course of pegylated interferon, which is already used in treating the virus. Trials with that combination are planned to begin later this year — and, if successful in achieving a functional cure on a defined course of treatment, could be a quick path to regulatory approval, Vir said.
Longer term, the biotech also hopes to combine VIR-2218 with a second proprietary experimental drug called VIR-3434, an HBV neutralizing antibody. That drug is expected to enter human testing later this year, with trials delayed by months because of the coronavirus pandemic.