Vir Biotechnology Completes Enrollment of Phase 2 Chronic Hepatitis Delta SOLSTICE Trial Ahead of Schedule

By: Vir Biotechnology, Inc. via Business Wire

March 05, 2024 at 08:05 AM EST

– Over 60 participants dosed in two additional cohorts; initial data expected in the second quarter –

– Approximately 50% of participants have compensated cirrhosis –

Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that its Phase 2 SOLSTICE clinical trial evaluating the safety, tolerability and efficacy of tobevibart and elebsiran for the treatment of people living with chronic hepatitis delta (CHD) virus has completed enrollment of its current cohorts one month earlier than anticipated. This includes over 60 participants in two additional cohorts – one evaluating tobevibart given every 2 weeks and the other evaluating the combination of tobevibart and elebsiran given every 4 weeks. Initial data are expected in the second quarter of 2024.

“The swift completion of enrollment ahead of expectations reflects the strong patient and physician interest being generated, and the urgent need for new treatment options for the millions of underserved hepatitis delta patients,” said Carey Hwang, M.D., Ph.D., Vir’s Senior Vice President, Clinical Research. “We are proud of the continued progress towards our goal of developing a safe and efficacious chronic therapy to address the significant treatment gap and look forward to reporting additional data on these participants this year.”

Of the participants dosed, approximately 50% have compensated cirrhosis. In the second quarter, the Company expects to report additional 12-week treatment data on 30 participants (15 per regimen) and 24-week treatment data on 20 participants (10 per regimen). Additional 24-week treatment data for all participants is expected in the fourth quarter of 2024.

SOLSTICE is a Phase 2 multi-center, open-label trial designed to evaluate the safety, tolerability, and efficacy of tobevibart and elebsiran in adult participants (age 18 to 69) with CHD infection receiving nucleot(s)ide reverse transcriptase inhibitor therapy. Depending on the cohort, trial participants are receiving multiple doses of tobevibart and elebsiran as either monotherapy or in combination administered via subcutaneous injection for up to 88 weeks. The primary endpoints of the trial are the proportion of study participants achieving either a ≥ 2log10 decrease in HDV RNA compared to baseline or HDV RNA less than the limit of detection and normalization of alanine transaminase (ALT) at Week 24.

About Tobevibart

Tobevibart is an investigational subcutaneously administered antibody designed to block entry of hepatitis B and hepatitis delta viruses into hepatocytes and to reduce the level of virions and subviral particles in the blood. Tobevibart, which incorporates Xencor’s Xtend™ and other Fc technologies, has been engineered to potentially function as a T cell vaccine against hepatitis B virus and hepatitis delta virus, as well as to have an extended half-life. Tobevibart was identified using Vir’s proprietary mAb discovery platform.

About Elebsiran

Elebsiran is an investigational subcutaneously administered hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) that Vir believes has the potential to stimulate an immune response and have direct antiviral activity against hepatitis B virus and hepatitis delta virus. 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 could result in an increased therapeutic index. Elebsiran is the first asset in the Company’s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical trials.

About Vir Biotechnology, Inc.

Vir Biotechnology, Inc. is an immunology company focused on powering the immune system to transform lives by treating and preventing infectious diseases and other serious conditions, including viral-associated diseases. Vir has assembled two technology platforms that are designed to modulate the immune system by exploiting critical observations of natural immune processes. Its current clinical development pipeline consists of product candidates targeting hepatitis delta and hepatitis B viruses and human immunodeficiency virus. Vir has several preclinical candidates in its pipeline, including those targeting influenza A and B, COVID-19, RSV/MPV and HPV. Vir routinely posts information that may be important to investors on its website.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir’s expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding Vir’s strategy and plans; the potential benefits, safety and efficacy of tobevibart and elebsiran for the treatment of chronic hepatitis delta; the timing and design of the Phase 2 SOLSTICE clinical trial, including enrollment and the anticipated timing of data readouts or presentations; statements regarding Vir’s scientific and executional expertise; and risks and uncertainties associated with drug development and commercialization. Many factors may cause differences between current expectations and actual results, including risks of unexpected safety or efficacy data or results observed during the Phase 2 SOLSTICE trial or in data readouts; the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; the timing and outcome of Vir’s planned interactions with regulatory authorities; difficulties in obtaining regulatory approval; challenges in accessing manufacturing capacity; clinical site activation rates or clinical trial enrollment rates that are lower than expected; difficulties in collaborating with other companies; successful development and/or commercialization of alternative product candidates by Vir’s competitors; changes in expected or existing competition; delays in or disruptions to Vir’s business or clinical trials due to geopolitical changes or other external factors; and unexpected litigation or other disputes. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later-stage or larger-scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240305632917/en/

Contacts

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Carly Scaduto

Senior Director, External Communications

cscaduto@vir.bio

+1 314-368-5189

Investors

Richard Lepke

Senior Director, Investor Relations

rlepke@vir.bio

+1 978-973-9986

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Vir Biotechnology Completes Enrollment of Phase 2 Chronic Hepatitis Delta SOLSTICE Trial Ahead of Schedule

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