[Translation] A Phase II, multicenter, randomized, open-label study evaluating the efficacy and safety of BRII-835 (VIR-2218) in combination with pegylated interferon alpha (PEG-IFNα) in the treatment of chronic hepatitis B virus (HBV) infection

本研究旨在评价 BRII-835 和 PEG-IFNα 联合治疗在接受 NRTI 背景治疗的慢性 HBV 感染非肝硬化受试者中的有效性和安全性。

[Translation]

This study aimed to evaluate the efficacy and safety of BRII-835 and PEG-IFNα combination therapy in non-cirrhotic subjects with chronic HBV infection receiving background NRTI therapy.

Start Date20 Oct 2023

Sponsor / Collaborator

Ajinomoto Althea, Inc.

[+2]

NCT05970289 / Active, not recruitingPhase 2

A Phase 2 Multicenter, Randomized, Open-label Study to Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and Pegylated Interferon Alpha (PEG-IFNα) Combination Therapy for the Treatment of Chronic Hepatitis B Virus (HBV) Infection

This study will evaluate the efficacy and safety of PEG-IFNα alone or in combination with different dose levels of BRII-835 (VIR-2218) in participants with chronic hepatitis B virus (HBV) infection.

Start Date22 Aug 2023

Sponsor / Collaborator

Brii Biosciences Ltd.

[+1]

NCT05844228 / RecruitingPhase 1

A Phase 1, Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of VIR-2218 in Adult Participants With Renal Impairment

The rationale of this study is to evaluate the impact of renal function on the PK, safety, and tolerability of VIR-2218 in participants with normal renal function and participants with varying degrees of renal dysfunction who are otherwise medically stable

Start Date01 Jun 2023

Sponsor / Collaborator

Vir Biotechnology, Inc.

100 Clinical Results associated with Elebsiran

100 Translational Medicine associated with Elebsiran

100 Patents (Medical) associated with Elebsiran

Literatures (Medical) associated with Elebsiran

01 Oct 2023·Journal of hepatology

Evaluation of RNAi therapeutics VIR-2218 and ALN-HBV for chronic hepatitis B: Results from randomized clinical trials

Article

Author: Lempp, Florian A ; Huang, Stephen A ; Gane, Ed ; Shen, Ling ; Cloutier, Daniel J ; Taubel, Jorg ; Cathcart, Andrea L ; Anglero-Rodriguez, Yesseinia I ; Jadhav, Vasant ; Kim, Jae B ; Milstein, Stuart ; Kaittanis, Charalambos ; Janas, Maja M ; Lim, Young-Suk ; Bakardjiev, Anna I ; Yuen, Man-Fung ; Pang, Phillip S ; Sepp-Lorenzino, Laura ; Hinkle, Gregory ; Haslett, Patrick ; Hebner, Christy M

BACKGROUND & AIMS:

Current therapy for chronic hepatitis B virus (cHBV) infection involves lifelong treatment. New treatments that enable HBV functional cure would represent a clinically meaningful advance. ALN-HBV and VIR-2218 are investigational RNA interference therapeutics that target all major HBV transcripts.

METHODS:

We report on: i) the safety of single doses of VIR-2218 (modified from ALN-HBV by enhanced stabilization chemistry plus technology to reduce off-target, seed-mediated binding while maintaining on-target antiviral activity) and ALN-HBV in humanized mice; ii) a cross-study comparison of the safety of single doses of VIR-2218 and ALN-HBV in healthy human volunteers (n = 24 and n = 49, respectively); and iii) the antiviral activity of two doses of 20, 50, 100, 200 mg of VIR-2218 (total n = 24) vs. placebo (n = 8), given 4 weeks apart, in participants with cHBV infection.

RESULTS:

In humanized mice, alanine aminotransferase (ALT) levels were markedly lower following administration of VIR-2218 compared with ALN-HBV. In healthy volunteers, post-treatment ALT elevations occurred in 28% of participants receiving ALN-HBV compared with none in those receiving VIR-2218. In participants with cHBV infection, VIR-2218 was associated with dose-dependent reductions in hepatitis B surface antigen (HBsAg). The greatest mean reduction of HBsAg at Week 20 in participants receiving 200 mg was 1.65 log IU/ml. The HBsAg reduction was maintained at 0.87 log IU/ml at Week 48. No participants had serum HBsAg loss or hepatitis B surface antibody seroconversion.

CONCLUSIONS:

VIR-2218 demonstrated an encouraging hepatic safety profile in preclinical and clinical studies as well as dose-dependent HBsAg reductions in patients with cHBV infection. These data support future studies with VIR-2218 as part of combination regimens with a goal of HBV functional cure.

TRIAL REGISTRATION:

ClinicalTrials.gov identifiers: NCT02826018 and NCT03672188.

IMPACT AND IMPLICATIONS:

A significant unmet need exists for therapies for chronic HBV (cHBV) infection that achieve functional cure. We report clinical and non-clinical data on two investigational small-interfering RNAs that target HBx, ALN-HBV and VIR-2218, demonstrating that incorporation of enhanced stabilization chemistry plus technology in VIR-2218 reduces its propensity to cause ALT elevations relative to its parent compound, ALN-HBV. We also show that VIR-2218 reduces hepatitis B surface antigen levels in a dose-dependent manner in participants with cHBV infection. These studies support the continued development of VIR-2218 as part of therapeutic regimens for cHBV infection, with the goal of a functional cure, and are important for HBV researchers and physicians.

01 Dec 2021·Drugs in R&DQ4 · MEDICINE

Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection

Q4 · MEDICINE

ArticleOA

Author: Li, Jing ; Shen, Ling ; Robbie, Gabriel J ; Gupta, Sneha V ; Fanget, Marie C ; Clausen, Valerie A ; Mogalian, Erik ; Cloutier, Daniel ; MacLauchlin, Christopher

BACKGROUND AND OBJECTIVE:

VIR-2218 is an investigational N-acetylgalactosamine-conjugated RNA interference therapeutic in development for chronic hepatitis B virus (HBV) infection. VIR-2218 was designed to silence HBV transcripts across all genotypes and uses Enhanced Stabilization Chemistry Plus (ESC+) technology. This study was designed to evaluate the single-dose pharmacokinetics of VIR-2218 in preclinical species and healthy volunteers.

METHODS:

Preclinically, a single subcutaneous dose of VIR-2218 (10 mg/kg) was administered to rats and nonhuman primates (NHPs), and the pharmacokinetics were assessed in plasma, urine, and liver using standard noncompartmental analysis (NCA) methods. Clinically, healthy volunteers were randomized (6:2 active:placebo) to receive a single subcutaneous dose of VIR-2218 (50-900 mg) or placebo. Pharmacokinetics were similarly assessed within human plasma and urine using NCA methods.

RESULTS:

In rats and NHPs, VIR-2218 was stable in plasma and was converted to AS(N-1)3'VIR-2218, the most prominent circulating metabolite, at < 10% plasma exposure compared with parent. VIR-2218 rapidly distributed to the liver, reaching peak liver concentrations within 7 and 24 h in rats and NHPs, respectively. In humans, VIR-2218 was rapidly absorbed, with a median time to peak plasma concentration (t_max) of 4-7 h, and had a short median plasma half-life of 2-5 h. Plasma exposures for area under the plasma concentration-time curve up to 12 h (AUC_0-12) and mean maximum concentrations (C_max) increased in a slightly greater-than-dose-proportional manner across the dose range studied. Interindividual pharmacokinetic variability was low to moderate, with a percent coefficient of variation of < 32% for AUC and < 43% for C_max. A portion of VIR-2218 was converted to an active metabolite, AS(N-1)3'VIR-2218, with a median t_max of 6-10 h, both of which declined below the lower limit of quantification in plasma within 48 h. The pharmacokinetic profile of AS(N-1)3'VIR-2218 was similar to that of VIR-2218, with plasma AUC_0-12 and C_max values ≤ 12% of VIR-2218. VIR-2218 and AS(N-1)3'VIR-2218 were detectable in urine through the last measured time point, with approximately 17-48% of the administered dose recovered in urine as unchanged VIR-2218 over 0-24 h postdose. Based on pharmacokinetics in preclinical species, VIR-2218 localizes to the liver and likely exhibits prolonged hepatic exposure. Overall, no severe or serious adverse events or discontinuations due to adverse events were observed within the dose range evaluated for VIR-2218 in healthy volunteers (Vir Biotechnology, Inc., unpublished data).

CONCLUSIONS:

VIR-2218 showed favorable pharmacokinetics in healthy volunteers supportive of subcutaneous dosing and continued development in patients with chronic HBV infection.

CLINICAL TRIAL REGISTRATION NO:

NCT03672188, September 14, 2018.

01 Dec 2013·Nature medicineQ1 · MEDICINE

Kinesin inhibitor marches toward first-in-class pivotal trial

Q1 · MEDICINE

Author: Owens, Brian

Array is also looking at a potential biomarker, alpha-1 acidic glycoprotein (AAG), which is often elevated in people with multiple myeloma.AAG is a ′cleanup′ protein in the blood serum that can bind to ARRY-520, rendering it ineffective.In a 32-person trial in which patients with myeloma received ARRY-520 alone, 5 of the 21 participants with low AAG levels showed a reduction in M protein that lasted for more than 8 mo on average, whereas none of the 5 participants with high AAG levels experienced such a favorable response.According to Koch, the findings, which will also be presented at the Dec. ASH meeting, suggest that AAG levels could help indicate who might be a good candidate for the drug. "There are very few mechanisms that show such strong single-agent activity," he says.Array is not the only company that has faith in the KSP pathway.At least two other companies, ArQule and Alnylam Pharmaceuticals, both based in the Boston area, are developing compounds that target KSP.ArQule′s ARQ 621 is being tested in both hematol. and solid tumor cancers, while Alnylam′s ALN-VSP is focused on liver cancer.ALN-VSP is unique among these drugs, as it does not target the KSP protein directly, but uses RNA interference to prevent it from being expressed in the first place.(ARQ 621, like ARRY-520, is a typical small mol. that′s administered i.v.) So far, both have only been tested in phase 1 trials.At first, ARRY-500 will probably be used only in people with myeloma who have failed on other drugs.But Andy Robbins, Array′s senior vice-president of com. and strategy, hopes that KSP inhibitors like ARRY-520 will one day form a frontline therapy, alongside the two entrenched classes of therapies: immunomodulators such as Revlimid (lenalidomide) and proteosome inhibitors such as Kyprolis and Velcade. "We have the potential to be a third backbone treatment," he says.

News (Medical) associated with Elebsiran

07 Jun 2024

·www.prnewswire.com

Brii Bio Presents New Data from Its Ongoing Phase 2 Chronic Hepatitis B Trials at EASL™ Congress 2024

New translational data demonstrate that BRII-179-induced immune responses are associated with high HBsAg reduction in a subset of participants with chronic HBV infection BRII-179 as add-on therapy induces functional antibody responses and contributes to improved sustained HBsAg loss in PEG-IFNa-treated participants with chronic HBV infection DURHAM, N.C. and BEIJING, June 7, 2024 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio," "we," or the "Company", stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet needs, presented new data from two Phase 2 studies evaluating BRII-179 either as a combination therapy with BRII-835 (elebsiran) or as an add-on therapy to pegylated interferon-alpha (PEG-IFNα) treatment for chronic hepatitis B virus (HBV) infection at the EASL™ (European Association for the Study of the Liver) Congress 2024. Data presented in an oral presentation from a Phase 2 clinical trial demonstrated BRII-179, a therapeutic vaccine, in combination with BRII-835 (elebsiran) induced substantial HBV-specific B and T cell responses that correlate with antiviral effect in a subset of participants with chronic HBV infection. The exploratory translational study evaluating the correlation of treatment-induced immune response with antiviral effects demonstrated: Pre-S1-specific T cell response targeting a region adjacent to sodium taurocholate cotransporting polypeptide (NTCP) was identified to be associated with high levels of HBsAg reduction in some participants receiving BRII-835 (elebsiran) and BRII-179. Ex vivo Pre-S1-specific Th1-type cytokines (IL-2) were detected in participants with high HBsAg reduction, while Th2-type responses were not associated with HBsAg reduction. BRII-179 induced robust anti-HBV neutralizing activity in participants with high levels of HBsAg reduction and HBsAb induction. "This study shows for the first time direct evidence that immune responses induced by an HBV therapeutic vaccine is associated with HBsAg reduction and viral control in some participants with chronic HBV infection," said Antonio Bertoletti, MD, Professor, Emerging Infectious Diseases Program at Duke-NUS Medical School. "The antiviral activity appears to be linked with a boosting of anti-HBs antibodies and Pre-S1-specific T cell responses induced by BRII-179, supporting that BRII-179 can break immune tolerance and have an impact on sustained control of the viral infection." Additionally, late-breaker poster presentation data from a Phase 2 clinical trial demonstrated that BRII-179, administrated on top of PEG-IFNα, improved overall HBsAg loss rate from end-of-treatment (EOT) to at least 24 weeks post nucleos(t)ide reverse transcriptase inhibitors (NRTI) discontinuation compared to the PEG-IFNα group. Follow-up data from this randomized, double-blind, placebo-controlled clinical trial in 114 virally-suppressed participants with chronic HBV infection showed: Among the participants who met NRTI discontinuation criteria and entered NRTI discontinuation monitoring period (NDMP), a higher percentage of participants in the BRII-179 + PEG-IFNα group maintained HBsAg loss (19.3% vs 12.3% in full analysis set [FAS]) compared to the placebo + PEG-IFNα group. The improvement in overall HBsAg loss rate was sustained from EOT (26.3% vs 19.3% in FAS) to at least 24-week post NRTI discontinuation (cut-off date) or 36-week post EOT in the BRII-179 + PEG-IFNα group. No participant who discontinued NRTI required NRTI retreatment. A higher percentage of participants in the BRII-179 + PEG-IFNα group maintaining HBsAg loss had HBsAb ≥ 100 IU/L compared to the placebo + PEG-IFNα group (36.4% vs 14.3% in FAS) at ≥ 24-week post NRTI discontinuation. No participant with HBsAb titer ≥ 100 IU/L at EOT experienced HBsAg changed from < 0.05 IU/mL (LLOQ) to ≥ 0.05 IU/mL (i.e. HBsAg rebound) through the cut-off date, suggesting that robust antibody responses against HBV are necessary for sustained off-treatment HBsAg loss. Treatment with BRII-179 and PEG-IFNα combination was generally safe and tolerated. No new risk was identified in the post EOT follow-up period and NDMP. The favorable benefit-risk profile and scientific insights from these studies support further clinical evaluation of BRII-179 in combination with other modalities such as siRNA and PEG-IFNα as key components for the treatment of chronic HBV infection, with the goal of achieving functional cure. About BRII-179 BRII-179 is a novel recombinant protein-based HBV immunotherapeutic candidate that expresses the Pre-S1, Pre-S2, and S HBV surface antigens, and is designed to induce enhanced and broad B-cell and T-cell immunity. Brii Bio licensed BRII-179 from VBI Vaccines, Inc. ("VBI") in December 2018 and has extended the exclusive license to global rights since July 2023. About BRII-835 (Elebsiran) BRII-835 (elebsiran) is an investigational subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an effective immune response and has direct antiviral activity against HBV and HDV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. Brii Bio licensed exclusive rights to develop and commercialize BRII-835 (elebsiran) for the greater China territory from Vir Biotechnology, Inc. ("Vir") in 2020. About Hepatitis B Hepatitis B virus (HBV) infection is one of the world's most significant infectious disease threats with more than 254 million people infected globally.[1] Chronic HBV infection is the leading cause of liver disease and an estimated 820,000 people die of complications from chronic HBV infection each year.[1] HBV is of exceptional concern in China, where 87 million people are chronically infected.[2] About Brii Bio Brii Biosciences Limited ("Brii Bio", stock code: 2137.HK) is a biotechnology company developing therapies to address major public health challenges where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious and central nervous system diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs against hepatitis B virus (HBV) infection. The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including Raleigh-Durham, the San Francisco Bay Area, Beijing and Shanghai. For more information, visit . SOURCE Brii Biosciences Limited

Clinical ResultPhase 2License out/inVaccineImmunotherapy

07 Jun 2024

·www.drugs.com

Brii Bio Presents New Data from Its Ongoing Phase 2 Chronic Hepatitis B Trials

DURHAM, N.C. and BEIJING, June 7, 2024. Brii Biosciences Limited ("Brii Bio," "we," or the "Company"), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet needs, presented new data from two Phase 2 studies evaluating BRII-179 either as a combination therapy with BRII-835 (elebsiran) or as an add-on therapy to pegylated interferon-alpha (PEG-IFNα) treatment for chronic hepatitis B virus (HBV) infection at the EASL™ (European Association for the Study of the Liver) Congress 2024. Data presented in an oral presentation from a Phase 2 clinical trial demonstrated BRII-179, a therapeutic vaccine, in combination with BRII-835 (elebsiran) induced substantial HBV-specific B and T cell responses that correlate with antiviral effect in a subset of participants with chronic HBV infection. The exploratory translational study evaluating the correlation of treatment-induced immune response with antiviral effects demonstrated: "This study shows for the first time direct evidence that immune responses induced by an HBV therapeutic vaccine is associated with HBsAg reduction and viral control in some participants with chronic HBV infection," said Antonio Bertoletti, MD, Professor, Emerging Infectious Diseases Program at Duke-NUS Medical School. "The antiviral activity appears to be linked with a boosting of anti-HBs antibodies and Pre-S1-specific T cell responses induced by BRII-179, supporting that BRII-179 can break immune tolerance and have an impact on sustained control of the viral infection." Additionally, late-breaker poster presentation data from a Phase 2 clinical trial demonstrated that BRII-179, administrated on top of PEG-IFNα, improved overall HBsAg loss rate from end-of-treatment (EOT) to at least 24 weeks post nucleos(t)ide reverse transcriptase inhibitors (NRTI) discontinuation compared to the PEG-IFNα group. Follow-up data from this randomized, double-blind, placebo-controlled clinical trial in 114 virally-suppressed participants with chronic HBV infection showed: The favorable benefit-risk profile and scientific insights from these studies support further clinical evaluation of BRII-179 in combination with other modalities such as siRNA and PEG-IFNα as key components for the treatment of chronic HBV infection, with the goal of achieving functional cure. About BRII-179 BRII-179 is a novel recombinant protein-based HBV immunotherapeutic candidate that expresses the Pre-S1, Pre-S2, and S HBV surface antigens, and is designed to induce enhanced and broad B-cell and T-cell immunity. Brii Bio licensed BRII-179 from VBI Vaccines, Inc. ("VBI") in December 2018 and has extended the exclusive license to global rights since July 2023. About BRII-835 (Elebsiran) BRII-835 (elebsiran) is an investigational subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an effective immune response and has direct antiviral activity against HBV and HDV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. Brii Bio licensed exclusive rights to develop and commercialize BRII-835 (elebsiran) for the greater China territory from Vir Biotechnology, Inc. ("Vir") in 2020. About Hepatitis B Hepatitis B virus (HBV) infection is one of the world's most significant infectious disease threats with more than 254 million people infected globally. [1] Chronic HBV infection is the leading cause of liver disease and an estimated 820,000 people die of complications from chronic HBV infection each year. [1] HBV is of exceptional concern in China, where 87 million people are chronically infected. [2] About Brii Bio Brii Biosciences Limited ("Brii Bio", stock code: 2137.HK) is a biotechnology company developing therapies to address major public health challenges where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious and central nervous system diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs against hepatitis B virus (HBV) infection. The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including Raleigh-Durham, the San Francisco Bay Area, Beijing and Shanghai References [1] World Health Organization. (April 2024). Global hepatitis report 2024: action for access in low- and middle-income countries. World Health Organization. Retrieved from https://www-who-int.libproxy1.nus.edu.sg/publications/i/item/9789240091672 [2] World Health Organization. Hepatitis. World Health Organization. Retrieved from https://www-who-int.libproxy1.nus.edu.sg/china/health-topics/hepatitis Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical ResultPhase 2VaccineLicense out/in

05 Jun 2024

·www.fiercebiotech.com

Vir pressures Gilead with hepatitis D cocktail showing early efficacy in phase 2

Vir Biotechnology is planning to talk to regulators about the next steps for its hepatitis D combination therapy. Vir Biotechnology's hepatitis D combination therapy has shown early efficacy in results from a phase 2 trial, suggesting the drug cocktail may pose a threat to Gilead Sciences' stuttering attempt to capture the market. Hepatitis D can only infect people if the hepatitis B virus is present. Compared to people with hepatitis B alone, people living with both viruses have a higher risk of irreversible liver damage and life-threatening complications. No treatments are approved in the U.S. Vir wants to change that with a drug combination designed to inhibit viral entry, neutralize virus particles and otherwise impede the pathogens. Vir shared early evidence it is on the right track Wednesday. The first six participants received tobevibart or elebsiran, the hepatitis D candidates, as a monotherapy before starting combination treatment. Two of the five people who spent 48 weeks on combination therapy met a combined endpoint that looked for signs of efficacy including undetectable hepatitis D RNA and normal levels of a liver damage marker. The biotech also shared data on 27 patients who started on the monthly drug combination. Twelve of the patients met the combined endpoint after 12 weeks of treatment. Vir only has 24-week data on 11 participants in the de novo combination cohort. The response rate was higher at 24 weeks, when seven of the subjects met the criteria. Vir saw similar response rates in patients who received tobevibart as a single agent. Fewer people on the monotherapy met the threshold for virologic response, but the effect on the liver damage marker was as good as in the combination arm, resulting in similar figures on the combined endpoint. The results suggest Vir may have an edge over Gilead’s bulevirtide, which has not been shown to lead to hepatitis D clearance and is injected daily. The next clinical trial could more clearly show how the rival treatments compare, as Carey Hwang, M.D., Ph.D., senior vice president of clinical research at Vir, said on a conference call with investors to discuss the data. “We are eager to engage with regulatory authorities in Q3 of this year to discuss the next steps for the development program. We anticipate that the next trial will use bulevirtide as comparator, and we look forward to aligning the clinical development plan with health authorities. Additionally, we will explore all available acceleration pathways,” Hwang said. However fast Vir moves, Gilead could still get to the U.S. market first. The FDA knocked back a request for approval of bulevirtide in 2022, but Gilead has submitted a filing intended to fix the manufacturing and delivery concerns raised in the complete response letter. Bulevirtide, which Gilead acquired in its MYR acquisition, is already available in Europe.

Phase 2Clinical ResultAcquisitionDrug Approval

100 Deals associated with Elebsiran

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis D, Chronic	Phase 2	BG	Vir Biotechnology, Inc.	17 Sep 2022
Hepatitis D, Chronic	Phase 2	FR	Vir Biotechnology, Inc.	17 Sep 2022
Hepatitis D, Chronic	Phase 2	DE	Vir Biotechnology, Inc.	17 Sep 2022
Hepatitis D, Chronic	Phase 2	IT	Vir Biotechnology, Inc.	17 Sep 2022
Hepatitis D, Chronic	Phase 2	MD	Vir Biotechnology, Inc.	17 Sep 2022
Hepatitis D, Chronic	Phase 2	NL	Vir Biotechnology, Inc.	17 Sep 2022
Hepatitis D, Chronic	Phase 2	NZ	Vir Biotechnology, Inc.	17 Sep 2022
Hepatitis D, Chronic	Phase 2	RO	Vir Biotechnology, Inc.	17 Sep 2022
Hepatitis D, Chronic	Phase 2	GB	Vir Biotechnology, Inc.	17 Sep 2022
Hepatitis B, Chronic	Phase 2	AU	Vir Biotechnology, Inc.	03 Jul 2020

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EASL2023	Phase 2	Hepatitis B, Chronic	79	VIR-2218 + PEG-IFNa	mnhhsrqyqt(hjwqtayjne) = unrelated to treatment rilirsxzpn (quvgpycyko ) View more	-	21 Jun 2023
NCT03672188 \| NCT02826018 (Pubmed)	Not Applicable	Hepatitis B, Chronic	-	VIR-2218	yrjeflqxuf(dafbxvyttf) = aavgwjvayj ihofqrnism (gwhaelhwqn )	-	06 Jun 2023
GlobeNewswire Manual	Phase 2	Hepatitis B	-	VIR-2218 (six-dose regimen of VIR-2218)	okxtplgwae(pqrtarzsiv) = all participants achieving a >1 log10 IU/mL reduction during the trial. uxgsfakvyf (vbbkgjfxiv ) View more	Positive	25 Jun 2022
				VIR-2218 (two-dose regimen of VIR-2218)
EASL2021	Phase 2	Hepatitis B, Chronic	27	VIR-2218 alone	psptopilzv(fdigdcukmr) = Some participants receiving Peg-IFNa and VIR-2218 combination experienced asymptomatic ALT elevations (grade 2 – 3) concurrent with HBsAg decline ( ≥ 1 log 10 IU/ ml). ALT elevations were not associated with functional changes of the liver (bilirubin, PT or INR). No serious AEs have been reported. mldmnjdivs (ufrrjwqakc )	-	23 Jun 2021
				VIR-2218 + Peg-IFNa
EASL2020	Phase 2	Hepatitis B, Chronic	24	VIR-2218 20 mg	gjpeckypqo(wdqyofuuyp) = No clinically significant ALTelevations were observed xiqloymltp (bdzvygrayi ) View more	-	27 Aug 2020
				VIR-2218 50 mg
Phase 2 (EASL2020)	Phase 2	Hepatitis B	-	VIR-2218	dqilkmmnde(rwlknsrbgw) = lnfrxsmwwa keekvimznv (zkajmopyfq ) View more	Positive	27 Aug 2020
				Placebo	knrxfodfve(cdcgcwmimk) = cyyxodchcu pwtsemalip (dmytgqtmqq )

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