A Phase 2 Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and Pegylated Interferon Alpha (PEG-IFNα) in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)

This Phase 2, randomized, double-blind study will evaluate the clinical efficacy and safety of the combination therapy of BRII-179, BRII-835, plus PEG-IFNα compared to PEG-IFNα in adult participants with chronic HBV infection without cirrhosis receiving neucloes(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy.

Start Date31 Oct 2024

Sponsor / Collaborator

Brii Biosciences Ltd.

CTR20243850

/ Active, not recruitingPhase 2

一项评价BRII-179、BRII-835和聚乙二醇干扰素α（PEG-IFNα）联合治疗在慢性乙型肝炎病毒（HBV）感染受试者中有效性和安全性的II期、多中心、随机、双盲研究（ENHANCE研究）

[Translation] A Phase II, multicenter, randomized, double-blind study to evaluate the efficacy and safety of BRII-179, BRII-835, and pegylated interferon alpha (PEG-IFNα) in subjects with chronic hepatitis B virus (HBV) infection (ENHANCE study)

本研究旨在评价BRII-179、BRII-835和PEG-IFNα联合治疗与PEG-IFNα治疗相比在接受核苷（酸）类逆转录抑制剂作为背景治疗的无肝硬化的慢性HBV成人感染受试者中的临床有效性和安全性。

[Translation]

This study aims to evaluate the clinical efficacy and safety of BRII-179, BRII-835, and PEG-IFNα combination therapy compared with PEG-IFNα therapy in adult subjects with chronic HBV infection without cirrhosis who are receiving background therapy with nucleos(t)ide reverse transcriptase inhibitors.

Start Date17 Oct 2024

Sponsor / Collaborator

SciVac Ltd.

[+2]

NCT06491563

/ Active, not recruitingPhase 2

A Phase 2 Multicenter, Open-label Study to Investigate the Efficacy and Safety of Regimens Containing BRII-179, BRII-835, and Pegylated Interferon Alpha (PEG-IFNα) for the Treatment of Chronic Hepatitis B Virus (HBV) Infection (ENRICH)

This study will evaluate the efficacy and safety of the regimens containing BRII-179, BRII-835, and PEG-IFNα in adult participants with chronic hepatitis B virus (HBV) infection receiving nucleos(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy.

Start Date06 Aug 2024

Sponsor / Collaborator

Brii Biosciences Ltd.

[+1]

100 Clinical Results associated with Elebsiran

100 Translational Medicine associated with Elebsiran

100 Patents (Medical) associated with Elebsiran

Literatures (Medical) associated with Elebsiran

01 Dec 2024·The Lancet Gastroenterology & Hepatology

VIR-2218 (elebsiran) plus pegylated interferon-alfa-2a in participants with chronic hepatitis B virus infection: a phase 2 study

Article

Author: Lim, Young-Suk ; Gane, Edward ; Thanawala, Vaidehi ; Heo, Jeong ; Cathcart, Andrea L ; Tangkijvanich, Pisit ; Cloutier, Daniel ; Mao, Shenghua ; Yoon, Ki Tae ; Tak, Won Young ; Lim, Tien-Huey ; Hwang, Carey ; Yuen, Man-Fung ; Gupta, Sneha V ; Arizpe, Andre

BACKGROUNDChronic hepatitis B virus (HBV) remains a global concern, with current treatments achieving low rates of HBsAg seroclearance. VIR-2218 (elebsiran), a small interfering RNA agent against HBV transcripts, reduces HBsAg concentrations. We aimed to evaluate the safety and antiviral activity of VIR-2218 with and without pegylated interferon-alpha-2a treatment in participants with chronic HBV.METHODSThis open-label, phase 2 study was conducted at 23 sites in six countries (New Zealand, Australia, Hong Kong, Thailand, South Korea, and Malaysia). Adults (aged 18-65 years) with chronic HBV infection without cirrhosis and with HBsAg more than 50 IU/mL and HBV DNA less than 90 IU/mL who were on continued nucleoside or nucleotide reverse transcriptase inhibitor (NRTI) therapy for 2 months or longer were eligible. Participants were enrolled into one of six cohorts to receive VIR-2218 200 mg subcutaneously every 4 weeks, with or without 180 μg subcutaneous pegylated interferon-alfa-2a once per week. Cohort 1 received six doses of VIR-2218 (total 20 weeks); cohort 2 received six doses of VIR-2218 starting at day 1, plus 12 doses of pegylated interferon-alfa-2a starting at week 12 (total 24 weeks); cohort 3 received six doses of VIR-2218 and 24 doses of pegylated interferon-alfa-2a (total 24 weeks); cohort 4 received six doses of VIR-2218 and up to 48 doses of pegylated interferon-alfa-2a (total 48 weeks); cohort 5 received up to 13 doses of VIR-2218 and up to 44 doses of pegylated interferon-alfa-2a (total 48 weeks); and cohort 6 received three doses of VIR-2218 and 12 doses of pegylated interferon-alfa-2a (total 12 weeks). The primary endpoints were the incidence of adverse events and clinical assessments (including results of laboratory tests). Secondary endpoints were the mean maximum reduction of serum HBsAg at any timepoint; the proportion of participants with serum HBsAg seroclearance at any timepoint and for more than 6 months after the end of treatment; and the proportion of participants with anti-HBs seroconversion at any timepoint. For patients who were HBeAg-positive, we also assessed the proportion with HBeAg seroclearance or anti-HBe seroconversion at any timepoint. This study is registered with ClinicalTrials.gov, NCT03672188, and is ongoing.FINDINGSBetween July 2, 2020, and Nov 2, 2021, 124 individuals were screened for eligibility, 84 of whom were enrolled (15 in cohort 1, 15 in cohort 2, 18 in cohort 3, 18 in cohort 4, 13 in cohort 5, and five in cohort 6). Participants were predominantly HBeAg-negative, Asian, and male (66 [79%] participants were male and 18 [21%] were female). Most treatment emergent adverse events were grades 1-2. Three (20%) participants in cohort 1, four (27%) in cohort 2, eight (44%) in cohort 3, seven (39%) in cohort 4, six (46%) in cohort 5, and two (40%) in cohort 6 reported treatment-emergent adverse events related to VIR-2218. 12 (80%) participants in cohort 2, 12 (67%) in cohort 3, 14 (78%) in cohort 4, 13 (100%) in cohort 5, and three (60%) in cohort 6 reported treatment-emergent adverse events related to pegylated interferon-alfa-2a. Two (13%) participants in cohort 1 had elevations in alanine aminotransferase, compared with 13 (87%) participants in cohort 2, 15 (83%) in cohort 3, 17 (94%) in cohort 4, 11 (85%) in cohort 5, and three (60%) in cohort 6. The mean maximum change from baseline at any timepoint in HBsAg concentration was -2·0 log₁₀ IU/mL (95% CI -2·1 to -1·8) in cohort 1, -2·2 log₁₀ IU/mL (-2·5 to -1·8) in cohort 2, -2·5 log₁₀ IU/mL (-2·8 to -2·1) in cohort 3, -2·4 log₁₀ IU/mL (-3·1 to -1·8) in cohort 4, -3·0 log₁₀ IU/mL (-3·7 to -2·3) in cohort 5, and -1·7 log₁₀ IU/mL (-2·1 to -1·4) in cohort 6. 11 participants (one in cohort 2, one in cohort 3, five in cohort 4, and four in cohort 5) receiving VIR-2218 plus pegylated interferon-alfa-2a had HBsAg seroclearance at any timepoint. Of these, ten (91%; one in cohort 2, five in cohort 4, and four in cohort 5) had anti-HBs seropositivity. Six participants (one in cohort 2, three in cohort 4, and two in cohort 5) had sustained HBsAg seroclearance through to 24 weeks after the end of treatment. No participants receiving VIR-2218 monotherapy (cohort 1) or VIR-2218 plus pegylated interferon-alfa-2a 12-week regimen (cohort 6) had HBsAg seroclearance. 12 (42%) of 26 participants (one of four in cohort 1, two of six in cohort 2, four of seven in cohort 3, four of six in cohort 4, and one of three in cohort 5) who were HBeAg positive at baseline had HBeAg seroclearance or anti-HBe seroconversion.INTERPRETATIONThe results of this phase 2 study support further development of VIR-2218 as a potential therapy for patients with chronic HBV infection. Additional clinical trials of VIR-2218 with and without pegylated interferon-alfa-2a in combination with an HBsAg-targeting monoclonal antibody are ongoing.FUNDINGVir Biotechnology.

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

BACKGROUND & AIMSCurrent 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.METHODSWe 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.RESULTSIn 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.CONCLUSIONSVIR-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 REGISTRATIONClinicalTrials.gov identifiers: NCT02826018 and NCT03672188.IMPACT AND IMPLICATIONSA 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 ; Clausen, Valerie A ; Cloutier, Daniel ; MacLauchlin, Christopher ; Fanget, Marie C ; Robbie, Gabriel J ; Gupta, Sneha V ; Shen, Ling ; Mogalian, Erik

BACKGROUND AND OBJECTIVEVIR-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.METHODSPreclinically, 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.RESULTSIn 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).CONCLUSIONSVIR-2218 showed favorable pharmacokinetics in healthy volunteers supportive of subcutaneous dosing and continued development in patients with chronic HBV infection.CLINICAL TRIAL REGISTRATION NONCT03672188, September 14, 2018.

News (Medical) associated with Elebsiran

13 Mar 2025

·pipelinereview.com

Vir Biotechnology Enrolls First Patient in Phase 3 ECLIPSE Registrational Program for Chronic Hepatitis Delta

SAN FRANCISCO, CA, USA I March 13, 2025 I Vir Biotechnology, Inc. (Nasdaq: VIR) today announced the enrollment of the first patient in its Phase 3 ECLIPSE registrational program. The ECLIPSE registrational program is designed to evaluate the efficacy and safety of tobevibart in combination with elebsiran in people living with chronic hepatitis delta (CHD). ECLIPSE 1, the first trial of the program to be initiated, and ECLIPSE 2 are Phase 3 trials designed to provide the registrational data needed for submission to multiple regulatory agencies. ECLIPSE 3, a Phase 2b trial, is designed to provide important supportive data to help enable access and reimbursement strategies in key European markets. “The start of the ECLIPSE program marks a pivotal moment for patients living with hepatitis delta and for Vir Biotechnology. With a proven track record of developing treatments powering the immune system to transform lives this achievement is a testament to our ability to rapidly advance impactful treatments from discovery to patient care,” said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. “The data from our SOLSTICE Phase 2 trial suggest that tobevibart and elebsiran can rapidly reduce hepatitis delta virus to undetectable levels, potentially driving important benefit for patients,” said Mark Eisner, M.D., M.P.H., Chief Medical Officer, Vir Biotechnology. “We are excited to further evaluate the potential of this combination in our Phase 3 program.” CHD is a debilitating inflammatory liver disease caused by the hepatitis delta virus (HDV). 1 It is the most severe form of chronic viral hepatitis 2 and on average, people living with CHD will progress to cirrhosis and liver failure within 5 years. 3 There is a high unmet medical need for effective treatments, as there are no approved therapies in the U.S., and options are limited in the European Union and globally. The objective of therapy is to eliminate the virus. Tobevibart in combination with elebsiran offers the potential to achieve this by tackling the viral lifecycle through multiple mechanisms. “Chronic hepatitis delta can be a devastating diagnosis, leaving all those impacted in the U.S. facing an uncertain future without approved treatment options,” said Chari A. Cohen, DrPH, M.P.H., President, Hepatitis B Foundation. “It is exciting to see potential new therapies for hepatitis delta, such as the combination of tobevibart and elebsiran, which could offer new hope to a community that has been waiting for efficacious treatment options for far too long.” The significant unmet need in CHD and the potential for tobevibart and elebsiran to provide a much-needed treatment option has been recognized by the U.S. Food and Drug Administration (FDA) with Breakthrough and Fast Track designations, and by the European Medicines Agency (EMA) Priority Medicines (PRIME) and orphan drug designation. About the ECLIPSE Registrational Program ECLIPSE is a Phase 3 registrational program to evaluate the safety and efficacy of tobevibart in combination with elebsiran in patients with chronic hepatitis delta. ECLIPSE includes three randomized, controlled trials designed to evaluate the combination therapy in comparison to deferred treatment or bulevirtide. ECLIPSE 1, the first trial of the program to be initiated, is a Phase 3 trial that will assess the efficacy and safety of tobevibart and elebsiran compared to deferred treatment in regions such as the U.S. where bulevirtide is not available or other regions where its access is limited. ECLIPSE 2 is a Phase 3 trial that will evaluate the efficacy and safety of switching to tobevibart and elebsiran in people with CHD who have not achieved viral suppression with bulevirtide therapy. ECLIPSE 1 and 2 are designed to provide the registrational efficacy and safety data needed for potential submission to global regulatory agencies. ECLIPSE 3 is a Phase 2b head-to-head trial to evaluate tobevibart and elebsiran compared with bulevirtide in bulevirtide-naïve patients, and it is designed to provide important supportive data to help establish access and reimbursement in key markets. ECLIPSE 1 plans to enroll 120 participants in the U.S. or other regions where bulevirtide use is limited. Participants will be randomized 2:1 to receive either tobevibart in combination with elebsiran or deferred treatment. During the deferred treatment period, participants will receive only nucleoside reverse transcriptase inhibitors (NRTIs). After the initial delay period, participants will be switched to the combination therapy of tobevibart and elebsiran. The composite primary endpoint measures HDV RNA at the lower limit of quantification target not detected or HDV RNA TND (defined as HDV RNA < 0 IU/mL) and ALT normalization at Week 48, compared to the deferred treatment group at the end of their deferred treatment period. About Tobevibart and Elebsiran Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen (HBsAg). It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart was identified using Vir Biotechnology’s proprietary monoclonal antibody discovery platform. The Fc domain has been engineered to increase immune engagement and clearance of HBsAg immune complexes and incorporates Xencor’s Xtend™ technology to extend half-life. Tobevibart is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta and patients with chronic hepatitis B. Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) discovered by Alnylam Pharmaceuticals, Inc. It is designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. Current data indicates that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. Elebsiran is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta and patients with chronic hepatitis B. About Vir Biotechnology, Inc. Vir Biotechnology, Inc., is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes infectious disease programs for chronic hepatitis delta and chronic hepatitis B infections and multiple dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology routinely posts information that may be important to investors on its website. References: 1 NIH National Institute of Diabetes and Digestive and Kidney Diseases Hepatitis D – NIDDK (nih.gov) , accessed February 2025 2 WHO Hepatitis Delta Factsheet – Hepatitis D (who.int) , accessed February 2025 3 CDC What is Hepatitis D – FAQ | CDC , accessed February 2025 SOURCE: Vir Biotechnology

Phase 2Orphan DrugFast TrackPhase 3

27 Feb 2025

·www.fiercebiotech.com

Vir, awaiting \'functional cure\' data for hep B combo, won\'t take treatment forward alone

“Future advancement” in CHB “will be contingent on securing a worldwide development and commercialization partner” outside of Greater China, Vir said.\n Vir Biotechnology may be pushing ahead with its combination therapy in hepatitis D, but it\'s pausing further development in hepatitis B while it seeks a suitable partner.Back in November, Vir arrived at a liver disease conference with phase 2 data showing that two combination regimens utilizing its drugs tobevibart and elebsiran were able to reduce hepatitis B surface antigens. With the news, the company planned to continue the trial to the 24-week stage in order to evaluate whether its cocktail therapy could act as a functional cure for chronic hepatitis B (CHB).According to the biotech’s fourth-quarter earnings release, Vir still expects this data in the second quarter of the year. But what happens next is up in the air.The “future advancement” in CHB “will be contingent on securing a worldwide development and commercialization partner” outside of Greater China, Vir said in the release. This is needed to “best enable further development in this area of high unmet need,\" the company explained.Earlier this month, GSK made a similar move, ending work on one potential functional cure for hepatitis B as it prioritized another in the form of bepirovirsen.With future hepatitis B development sidelined for now, Vir will be steaming ahead with plans to launch a phase 3 trial of the tobevibart-elebsiran combo in hepatitis D in the first half of this year. Early efficacy results from a phase 2 trial last summer suggested the treatment may pose a threat to Gilead Sciences\' stuttering attempt to capture the hepatitis D 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 hepatitis D treatments are yet approved in the U.S., where Gilead’s bulevirtide was swatted away by the FDA in 2022. Gilead has since submitted a filing intended to fix the manufacturing and delivery concerns raised in the agency’s complete response letter, and bulevirtide is already available in Europe.Vir also has two solid tumor-focused dual-masked T-cell engager programs in phase 1 trials, with a third due to enter the clinic in the first half of the year. “2024 was a year of transformation for Vir Biotechnology as we successfully defined and executed on our renewed strategic direction, focusing our resources on our most promising programs in infectious diseases and oncology,” CEO Marianne De Backer, Ph.D., said in the Feb. 26 release.“As we enter 2025, we are poised for significant advancement with the initiation of our phase 3 registrational program in chronic hepatitis delta and further clinical progression of our dual-masked T-cell engagers in solid tumors,” De Backer added. “Our disciplined capital deployment and strategic approach to partnerships enable us to maximize value creation from our pipeline and deliver transformative therapies to patients.”

$Vir, awaiting \'functional cure\' data for hep B combo, won\'t take treatment forward alone$

Phase 2Phase 1

27 Feb 2025

·endpts.com

Hansoh ends collaboration with Silence; Vir hunts for HBV drug partner

Plus, news about Alopexx, Medigene, EpimAb and Belite Bio: Hansoh backs out of siRNA pact with Silence Therapeutics: The London-based biotech said Hansoh has decided not to pursue further development of three siRNAs. The companies have been collaborating on the programs since 2021 as part of a deal that includes $1.3 billion in potential milestones. Silence also said it will not advance its treatment candidate for high Lp(a), dubbed zerlasiran, into a Phase 3 cardiovascular outcomes study until it secures a partner. The zerlasiran pause should extend its cash runway into 2027. — Ayisha Sharma Vir Biotechnology seeks ex-China partner for hepatitis B combo: The San Francisco-based biotech said further development of its monoclonal antibody tobevibart and siRNA elebsiran will depend on securing a development and commercialization partner. The company anticipates functional cure data from a Phase 2 study of the combination in the second quarter. — Ayisha Sharma A biotech IPO three years in the making: Alopexx, a Cambridge, MA-based biotech that has been trying to go public since winter 2022, updated its NYSE listing plans this week to say it aims for $9.9 million in net proceeds from a potential Wall Street debut as “ALPX.” The clinical-stage startup is working on antibodies and vaccines for bacterial, fungal and parasitic infections. — Kyle LaHucik Medigene, EpimAb join forces to develop T cell engagers: The multi-target deal combines Medigene’s T cell receptor know-how with EpimAb’s CD3 antibody and T-FIT technology. Both companies will share ownership over the resulting bispecific treatments for immune-mediated diseases, including solid tumors. The financial terms of the deal were not disclosed. — Ayisha Sharma Safety board clears Belite Bio’s Stargardt disease trial: The independent data safety monitoring board said Belite’s Phase 3 study of tinlarebant in teenage patients can proceed without any changes based on an interim analysis. This means the biotech doesn’t need to enroll any more patients to boost the trial’s statistical power. The study is set to end in the fourth quarter. — Ayisha Sharma

Phase 3IPOPhase 2

100 Deals associated with Elebsiran

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis D, Chronic	Phase 3	-	Vir Biotechnology, Inc.	13 Mar 2025
Hepatitis B, Chronic	Phase 2	New Zealand	Alnylam Pharmaceuticals, Inc.	03 Jul 2020
Hepatitis B, Chronic	Phase 2	Thailand	Alnylam Pharmaceuticals, Inc.	03 Jul 2020
Hepatitis B, Chronic	Phase 2	Hong Kong	Vir Biotechnology, Inc.	03 Jul 2020
Hepatitis B, Chronic	Phase 2	South Korea	Vir Biotechnology, Inc.	03 Jul 2020
Hepatitis B, Chronic	Phase 2	Thailand	Vir Biotechnology, Inc.	03 Jul 2020
Hepatitis B, Chronic	Phase 2	Australia	Vir Biotechnology, Inc.	03 Jul 2020
Hepatitis B, Chronic	Phase 2	Malaysia	Alnylam Pharmaceuticals, Inc.	03 Jul 2020
Hepatitis B, Chronic	Phase 2	Malaysia	Vir Biotechnology, Inc.	03 Jul 2020
Hepatitis B, Chronic	Phase 2	New Zealand	Vir Biotechnology, Inc.	03 Jul 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ENSURE (NEWS) Manual	Phase 2	Hepatitis B	-	Elebsiran 200 mg+PEG-IFNα	(xxdekluwok) = cytgihimfo fkzkbshbjn (qchzqjtdjv ) View more	Positive	19 Nov 2024
				Elebsiran 100mg+PEG-IFNα	(xxdekluwok) = jmtlikubsn fkzkbshbjn (qchzqjtdjv ) View more
NCT04507269 (CTgov)	Phase 2	Hepatitis B, Chronic	21	VIR-2218 (Part 1: VIR-2218 50 mg)	jhkgddfhzs(hrxlmqrzkk) = jcyrgyweav wizrbrllpm (vbutbsybur, yzcwuflfic - vqydrlmskq) View more	-	26 Aug 2024
				VIR-2218 (Part 1: VIR-2218 100 mg)	jhkgddfhzs(hrxlmqrzkk) = xvbsysmsbh wizrbrllpm (vbutbsybur, aucfivtpon - ktaykbcezy) View more
NCT05461170 (SOLSTICE, EASL2024) Manual	Phase 2	Hepatitis D, Chronic	33	Tobevibart 300 mg plus Elebsiran 200 mg	(zwllupinlt) = pcilamoxsi mvvjxygoqx (avwdanpnhi ) View more	Positive	01 Jun 2024
				Tobevibart 300 mg	(zwllupinlt) = gjqfszfwsg mvvjxygoqx (avwdanpnhi ) View more
NCT04856085 (MARCH, Biospace) Manual	Phase 2	Hepatitis B, Chronic	-	VIR-343+VIR-2218+peginterferon alpha	ozodxejkqx(tveqdketfo) = xzrglejpwl grsruhguxu (ezxxitvegh ) View more	Positive	13 Nov 2023
				VIR-343+VIR-2218	ozodxejkqx(tveqdketfo) = sxaszxfudi grsruhguxu (ezxxitvegh )
NCT03672188 \| NCT02826018 (Pubmed \| J Hepatol)	Phase 1/2	Hepatitis B, Chronic	-	VIR-2218	ktgslcsyyc(hfmvqakcwl) = fwfguxunam banscxnouc (sjgtmpluzj )	-	06 Jun 2023
GlobeNewswire Manual	Phase 2	Hepatitis B	-	VIR-2218VIR-2218 (six-dose regimen of VIR-2218)	kkpajaeaby(xlgagmmksk) = all participants achieving a >1 log10 IU/mL reduction during the trial. zraushfrob (srjecdneoh ) View more	Positive	25 Jun 2022
				VIR-2218VIR-2218 (two-dose regimen of VIR-2218)
EASL2021	Phase 2	Hepatitis B, Chronic	27	VIR-2218 alone	yhkbvsobrg(splqtecotn) = 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. tlxuuenzmd (qplsygbeey )	-	23 Jun 2021
				VIR-2218 + Peg-IFNa
EASL2020	Phase 2	Hepatitis B	-	VIR-2218	rgtatpihwt(pnvecrlhcl) = vmkrwuutzt ccidofiyfl (faoilploye ) View more	Positive	27 Aug 2020
				Placebo	nysiqriewk(gredhxpgwd) = kpsuusqssx cenwumybyp (zlloplsxsx )

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Regulation

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Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Elebsiran

Overview

Basic Info

Structure/Sequence

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation