"Functional Cure" Hepatitis B Dawn, Neutralizing Antibody and RNAi Therapy, The Newest Clinical Results Are Positive

Hepatitis B brings a huge medical burden worldwide, and more than 300 million people are affected by it

Yesterday, Vir Biotechnology company announced its functionality designed to cure RNAi innovation and the latest clinical results and antibody therapy of hepatitis

RNAi therapy VIR-2218 continues to reduce the level of hepatitis B virus surface antigen

A number of previous scientific studies have shown that the reason why chronic hepatitis B is difficult to cure is that in addition to HBV replication in the body, the large amount of protein produced by the virus can inhibit the body's immune response, causing immune cells to fail to control the virus' replication

VIR-2218, jointly developed by Vir and Alnylam Pharmaceuticals, is an RNAi therapy targeting the X gene of HBV

It uses Alnylam's ESC+ technology to reduce the off-target effect of siRNA, thereby reducing the toxic side effects of the therapy

▲Introduction to VIR-2218 (picture source: reference [2])

In the phase 1/2 clinical trial, patients with chronic hepatitis B received two doses of VIR-2218 or placebo 28 days apart

Further data analysis showed that high-dose VIR-2218 was associated with a long-lasting reduction in HBsAg levels

▲High-dose VIR-2218 is related to the continuous reduction of HBsAg (picture source: reference [2])

VIR-2218 is more effective in combination with immunomodulators

Reducing HBsAg levels is only the first step in restoring the function of the patient's immune system

Early clinical trial results showed that the combination of VIR-2218 and PEG-IFN-α (dark blue data points in the figure below) compared with VIR-2218 alone, after 12 weeks of treatment, further reduced the HBsAg level by 0.

▲VIR-2218 combined with PEG-IFN-α to further reduce the level of HBsAg (picture source: reference [4])

Vir is currently or planned clinical trials, the VIR-2218 with different types of immunomodulatory drug combination, and explore the potential of combination therapy to cure hepatitis B in terms of functionality

▲VIR-2218 combined with different immunomodulators is the main strategy to functionally cure hepatitis B (picture source: Vir Biotechnology official website)

Neutralizing antibody therapy with "vaccine" features significantly reduces HBsAg levels

The neutralizing antibody VIR-3434 developed by Vir is a neutralizing antibody therapy with multiple mechanisms of action

▲The modification of the Fc end of the neutralizing antibody gives VIR-3434 the potential to become a therapeutic vaccine (picture source: reference [3])

Previously announced early clinical results showed that with only a very low dose of 6 mg, VIR-3434 can rapidly reduce HBsAg after 8 days

Vir’s latest data today shows that among patients with chronic hepatitis B who received a dose of 18 mg of VIR-3434 or placebo, some patients’ HBsAg levels dropped significantly after 2 days of receiving one dose, and 7 days after receiving treatment.

▲The change in HBsAg level caused by VIR-3434 or placebo (picture source: reference [3])

Safety and pharmacokinetic studies conducted in healthy volunteers show that VIR-3434 still has good safety and tolerability when the dose reaches 3000 mg.

Vir company executives said that based on the good safety of VIR-3434, the company plans to continue to explore the effect of increasing the single dose of VIR-3434 and multiple doses

"The hope in this field for many years is that reducing viral antigen levels can improve the ability of immunomodulatory drugs to control chronic hepatitis

Reference materials:

[1] Vir Biotechnology Presents New Clinical Data from Ongoing Trials of VIR-2218 and VIR-3434 in Patients with Chronic Hepatitis B Virus Infection at the International Liver Congress 2021.
Retrieved June 25, 2021, from https://investors.
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bio/news-releases/news-release-details/vir-biotechnology-presents-new-clinical-data-ongoing-trials-vir

[2] Safety and Antiviral Activity of VIR-2218, An X-Targeting RNAi Therapeutic, In Participants With Chronic Hepatitis B Infection: Week 48 Follow-Up Results.
Retrieved June 25, 2021, from https://investors.
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bio /static-files/435251ac-661c-46a0-90a6-c5dd163235b2

[3] A Phase 1 Study Evaluating the Neutralizing, Vaccinal Monoclonal Antibody VIR-3434 in Participants With Chronic Hepatitis B Virus Infection: Preliminary Results.
Retrieved June 25, 2021, from https://investors.
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bio/static-files/ 19f65691-4133-41e9-b4eb-d3ad5a4045ba

[4] Preliminary On-Treatment Data From a Phase 2 Study Evaluating VIR-2218 in Combination With Pegylated Interferon Alfa-2a in Patients With Chronic Hepatitis B Infection.
Retrieved June 25, 2021, from https://investors.
vir.
bio/ static-files/d0288562-6067-4c7f-929b-fffa9debc978