– Data from a number of ongoing trials evaluating Vir’s two novel HBV therapies proceed to display substantial reductions in hepatitis B floor antigen (HBsAg) with no new security indicators –
– Preliminary knowledge to-date present that 30.8% of members receiving 48 weeks of VIR-2218 plus pegylated interferon alpha achieved HBsAg seroclearance with anti-HBs seroconversion by finish of therapy –
SAN FRANCISCO, Nov. 06, 2022 (GLOBE NEWSWIRE) — Vir Biotechnology, Inc. (Nasdaq: VIR) at present introduced new knowledge from its strong hepatitis B virus (HBV) portfolio aimed toward attaining a practical treatment. These knowledge, plus well being outcomes analysis, are being offered at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® in two oral shows, each of which have been chosen for inclusion in the “Best of the Liver Meeting” abstract, a poster and a late-breaking poster presentation. The “Best of the Liver Meeting” designation underscores the power of Vir’s broad hepatitis portfolio, which is addressing each HBV and hepatitis D virus (HDV).
In one oral presentation, new preliminary knowledge from an ongoing Phase 2 trial demonstrated that 30.8% of members receiving 48 weeks of VIR-2218, an investigational small interfering ribonucleic acid (siRNA), initiated concurrently with pegylated interferon alpha (PEG-IFN-α), achieved HBsAg seroclearance with anti-HBs seroconversion. Additionally, 48 weeks of VIR-2218 plus PEG-IFN-α supplied larger reductions in hepatitis B floor antigen (HBsAg) (imply lower of -2.9 log10 IU/mL) in comparison with VIR-2218 alone or with shorter regimens of the mixture. No new security indicators have been recognized.
“These new preliminary data demonstrate that VIR-2218 can be potentiated by immunomodulating agents such as pegylated interferon to achieve meaningful HBsAg loss,” mentioned Professor Man-Fung Yuen, D.Sc., M.D., Ph.D., chief of division of gastroenterology and hepatology, The University of Hong Kong, Li Shu Fan Medical Foundation professor in medication. “The higher rates of HBsAg seroclearance with anti-HBs seroconversion by the end of the 48-week treatment could be indicative of the potential for this regimen to serve as a curative chronic HBV treatment with a finite duration.”
In a separate oral presentation, new outcomes from Part A of the Phase 2 MARCH (Monoclonal Antibody siRNA Combination in opposition to Hepatitis B) trial, together with all three cohorts, demonstrated a imply HBsAg discount of >2.5 log10 IU/mL. These knowledge confirmed that VIR-2218 and VIR-3434, an investigational HBsAg-targeting monoclonal antibody engineered to probably act as a therapeutic vaccine, are additive in lowering HBsAg. The mixture of VIR-2218 and VIR-3434 by way of as much as 20 weeks of therapy in Part A was usually effectively tolerated. Combining the learnings from the VIR-2218 plus PEG-IFN-α trial with these encouraging new outcomes have led to extra cohorts evaluating the triple mixture of VIR-2218, VIR-3434 and PEG-IFN-α being added to Part B of the MARCH trial. Initial knowledge from Part B are anticipated in the second half of 2023.
Additionally, Phase 1 knowledge offered as a poster demonstrated {that a} single 75 mg or 300 mg dose of VIR-3434 resulted in fast reductions in HBsAg and HBV DNA in the majority of viremic members with continual HBV an infection in the absence of nucleot(s)ide reverse transcriptase inhibitor (NRTI) remedy. Finally, a real-world evaluation of 20 years of medical data in the U.S., to be highlighted in a late-breaking poster presentation, revealed that the majority of individuals with continual HBV an infection remained untreated all through the examine interval.
“The new data from our ongoing therapeutic combination trials continues to support our strategy of combining an antiviral with an immunomodulator and we believe are encouraging steps forward in our pursuit of developing a functional cure for the approximately 300 million people living with chronic HBV,” mentioned Carey Hwang, M.D., Ph.D., Vir’s senior vice chairman, scientific analysis, head of continual an infection. “We are excited by these data, which are important milestones in the development of our novel HBV compounds VIR-2218 and VIR-3434. We look forward to reporting additional clinical data from one of Vir’s most advanced development programs in 2023.”
Summary of AASLD 2022 Presentations
Oral Presentation – VIR-2218 in Combination with PEG-IFN-α
Preliminary 48-week security and efficacy knowledge from novel investigative cohorts of VIR-2218 alone and together with PEG-IFN-α in members with continual HBV an infection demonstrated:
- Longer period (48 weeks) of VIR-2218 plus PEG-IFN-α therapy achieved increased charges of HBsAg seroclearance with anti-HBs seroconversion by the finish of therapy (30.8%, 4/13).
- Participants receiving longer period of VIR-2218 plus PEG-IFN-α had biggest imply declines from baseline HBsAg (log10 IU/mL) ranges at week 48 (2.9 ± 1.36).
- 10 members receiving VIR-2218 plus PEG-IFN-α achieved HBsAg seroclearance by week 48, and 9 achieved anti-HBs ranges >10 mIU/mL.
- Most antagonistic occasions (AEs) reported have been grade 1 or 2 with no discontinuations resulting from treatment-emergent AEs.
Presenter: Prof. Man-Fung Yuen, D.Sc., M.D., Ph.D., MBBS, Deputy Department Chairperson, Chief of Division of Gastroenterology and Hepatology, Master of Lap-Chee College, The University of Hong Kong, Li Shu Fan Medical Foundation Professor in Medicine (Abstract #33507; Oral #19)
Oral Presentation – VIR-2218 in Combination with VIR-3434
Preliminary knowledge from the ongoing open-label Phase 2 MARCH examine evaluating the security, tolerability and antiviral exercise of VIR-2218 together with VIR-3434 in virally suppressed members with continual HBV an infection who obtained steady NRTI remedy for 2 months or extra demonstrated:
- VIR-2218 and VIR-3434 mixture regimens achieved imply HBsAg reductions >2.5 log10 IU/mL in all cohorts, and absolute HBsAg ranges <10 IU/mL have been achieved in most members.
- Patterns of response demonstrated additive HBsAg discount from the complementary modes of motion of VIR-2218 and VIR-3434.
- All AEs have been gentle to reasonable in severity. No AEs led to therapy discontinuation.
Presenter: Prof. Edward Gane, M.D., Professor of Medicine at the University of Auckland, New Zealand, and Chief Hepatologist, Transplant Physician and Deputy Director of the New Zealand Liver Transplant Unit at Auckland City Hospital (Abstract #33496; Oral # 18)
Poster Presentation – VIR-3434
Preliminary knowledge from an ongoing randomized, double-blind, placebo-controlled, Phase 1, single ascending dose examine of the security, tolerability and antiviral exercise of VIR-3434 in viremic members with continual HBV an infection demonstrated:
- Among members randomly assigned to VIR-3434, imply HBsAg change from baseline at nadir was −1.77 log10 IU/mL and −1.83 log10 IU/mL in the 75 mg and 300 mg teams, respectively.
- Among members randomly assigned to VIR-3434, imply HBV DNA change from baseline at nadir was −1.40 log10 IU/mL and −2.03 log10 IU/mL in the 75 mg and 300 mg teams, respectively.
- Across each cohorts, 11/12 members randomly assigned to VIR-3434 achieved a > 1 log10 IU/mL discount in HBsAg, and 11/12 achieved a > 1 log10 IU/mL discount in HBV DNA
- All AEs have been grade 1 or 2 in severity. No severe AEs or AEs main to check discontinuation have been reported.
Presenter: Kosh Agarwal, M.D., Consultant Hepatologist and Transplant Physician at the Institute of Liver Studies, Kings College Hospital, London (Abstract #36195; Poster #1187)
Late-Breaking Poster Presentation – Real-World Findings of HBV Treatment Patterns
A retrospective, observational evaluation utilizing digital well being data from two built-in well being care supply programs in the U.S. from January 1, 2000, to December 31, 2020, in contrast baseline traits for handled (i.e., these receiving no less than a 60-day consecutive course of NRTI or interferon alfa) and untreated sufferers with continual HBV an infection in routine scientific follow. Results confirmed:
- Of the 3,296 therapy naïve people at cohort entry, 842 (25%) have been handled after cohort entry and a couple of,469 (75%) remained untreated for the period of the examine.
- Among handled sufferers, 95% obtained an NRTI and 5% obtained interferon alfa. Treated sufferers have been extra probably than therapy naïve sufferers to be male, older, White, and enrolled in Medicare or Medicaid and extra prone to have a better Fibrosis-4 Index (FIB-4) rating, to be HBeAg-positive, and to have decrease HBV DNA ranges.
Presenter: Sacha Satram, Ph.D., Director, Health Economics & Outcomes Research at Vir Biotechnology (Abstract #38827; Poster #5045)
About Chronic Hepatitis B
Chronic hepatitis B virus (HBV) an infection stays an pressing world public well being problem related to vital morbidity and mortality. Approximately 300 million individuals round the world live with HBV, and roughly 900,000 of them die from related issues annually. These sufferers are considerably underserved by present therapies with low practical treatment charges, lifelong day by day remedy and poor tolerability. Vir is working to attain a practical treatment for the hundreds of thousands of individuals with HBV round the world by way of its broad and differentiated portfolio.
About Chronic Hepatitis D
Chronic hepatitis D virus (HDV) an infection happens as a simultaneous co-infection or super-infection with hepatitis B virus (HBV). An estimated 12 million sufferers globally are contaminated with HDV, representing roughly 5% of these contaminated with HBV. HDV-HBV co-infection is taken into account the most extreme type of continual viral hepatitis resulting from extra fast development towards hepatocellular carcinoma and liver-related dying.
About VIR-2218
VIR-2218 is an investigational subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an efficient immune response and have direct antiviral exercise in opposition to HBV and HDV. It is the first siRNA in the clinic to incorporate Enhanced Stabilization Chemistry Plus (ESC+) know-how to reinforce stability and decrease off-target exercise, which probably may end up in an elevated therapeutic index. VIR-2218 is the first asset in the Company’s collaboration with Alnylam Pharmaceuticals, Inc. to enter scientific trials.
About VIR-3434
VIR-3434 is an investigational subcutaneously administered antibody designed to dam entry of HBV and HDV viruses into hepatocytes and to scale back the degree of virions and subviral particles in the blood. VIR-3434, which includes Xencor’s Xtend™ and different Fc applied sciences, has been engineered to probably operate as a T cell vaccine in opposition to HBV and HDV in contaminated sufferers, in addition to to have an prolonged half-life.
About Vir Biotechnology
Vir Biotechnology is a commercial-stage immunology firm centered on combining immunologic insights with cutting-edge applied sciences to deal with and forestall severe infectious ailments. Vir has assembled 4 know-how platforms which are designed to stimulate and improve the immune system by exploiting essential observations of pure immune processes. Its present improvement pipeline consists of product candidates focusing on COVID-19, hepatitis B and hepatitis D viruses, influenza A and human immunodeficiency virus. Vir routinely posts info that could be vital to buyers on its web site.
Forward-Looking Statements
This press launch incorporates forward-looking statements inside the which means of the Private Securities Litigation Reform Act of 1995. Words akin to “may,” “will,” “plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and related expressions (in addition to different phrases or expressions referencing future occasions, situations or circumstances) are meant to determine forward-looking statements. These forward-looking statements are primarily based on Vir’s expectations and assumptions as of the date of this press launch. Forward-looking statements contained on this press launch embody, however will not be restricted to, statements concerning Vir’s technique and plans; the potential scientific results of VIR-2218, VIR-3434, VIR-2218 together with VIR-3434 and VIR-2218 together with pegylated interferon alfa; the potential advantages, security and efficacy of VIR-2218, VIR-3434, VIR-2218 together with VIR-3434 and VIR-2218 together with pegylated interferon alfa; the preliminary knowledge of VIR-2218 together with pegylated interferon alfa; the preliminary outcomes of the MARCH trial; Vir’s plans and expectations for its HBV portfolio; and dangers and uncertainties related to drug improvement and commercialization. Many vital components might trigger variations between present expectations and precise outcomes, together with surprising security or efficacy knowledge or outcomes noticed throughout scientific trials or in knowledge readouts, together with the ongoing scientific trial of VIR-2218 together with pegylated interferon alfa, the MARCH trial and the Phase 1 trial of VIR-3434; the prevalence of antagonistic security occasions; dangers of surprising prices, delays or different surprising hurdles; difficulties in collaborating with different corporations; profitable improvement and/or commercialization of different product candidates by Vir’s rivals; modifications in anticipated or present competitors; delays in or disruptions to Vir’s business or scientific trials resulting from the COVID-19 pandemic, geopolitical modifications (together with the warfare in Ukraine) or different exterior components; and surprising litigation or different disputes. Drug improvement and commercialization contain a excessive diploma of danger, and solely a small variety of analysis and improvement packages end in commercialization of a product. Results in early-stage scientific trials is probably not indicative of full outcomes or outcomes from later stage or bigger scale scientific trials and don’t guarantee regulatory approval. You mustn’t place undue reliance on these statements, or the scientific knowledge offered. Other components which will trigger precise outcomes to vary from these expressed or implied in the forward-looking statements on this press launch are mentioned in Vir’s filings with the U.S. Securities and Exchange Commission, together with the part titled “Risk Factors” contained therein. Except as required by legislation, Vir assumes no obligation to replace any forward-looking statements contained herein to mirror any change in expectations, at the same time as new info turns into out there.
