Vir Biotechnology Completes Enrollment of Phase 2 Chronic Hepatitis Delta SOLSTICE Trial Ahead of Schedule
Vir Biotechnology (VIR) completes enrollment in Phase 2 SOLSTICE trial for chronic hepatitis delta treatment ahead of schedule. Initial data expected in Q2 2024. Approximately 50% of participants have compensated cirrhosis.
The completion of enrollment for Vir Biotechnology's Phase 2 SOLSTICE clinical trial represents a significant milestone in the development of treatments for chronic hepatitis delta (CHD) virus. As a Medical Research Analyst, it's crucial to recognize the implications of this trial reaching its enrollment target ahead of schedule. This acceleration suggests a high level of interest and need within the patient and physician communities for new therapeutic options. CHD, being the most severe form of viral hepatitis, lacks effective treatment options and the current standard of care is limited. Therefore, the development of tobevibart and elebsiran could potentially fulfill an unmet medical need.
From a clinical development perspective, the inclusion of participants with compensated cirrhosis, which accounts for approximately 50% of the study population, is notable. This demographic is significant because cirrhosis represents a late stage of liver disease and patients with this condition are often excluded from clinical trials. Including these patients can provide valuable data on the efficacy and safety of the investigational drugs in a population with advanced liver disease. The primary endpoints focusing on virological response and liver enzyme normalization are standard for antiviral therapy trials and crucial for determining the potential clinical benefits of the treatments.
From a market perspective, the progress of the SOLSTICE trial is a pivotal event for stakeholders in Vir Biotechnology. The earlier-than-expected completion of cohort enrollment could be perceived positively by investors, as it indicates efficiency in trial management and a potential reduction in development timelines. The anticipation of initial data in the second quarter of 2024 and additional data releases throughout the year could create several key inflection points for the company's stock valuation.
It is important to assess the size of the market opportunity for CHD treatments. With millions of individuals affected worldwide and limited therapeutic options, the market potential for successful treatments is significant. This is particularly relevant as approximately 70% of CHD patients may progress to cirrhosis or hepatocellular carcinoma, underscoring the urgent need for effective therapies. If tobevibart and elebsiran demonstrate favorable safety and efficacy profiles, they could capture a substantial share of this market, subject to regulatory approval and market access considerations.
As a Hepatology Expert, analyzing the therapeutic potential of tobevibart and elebsiran involves understanding their mechanism of action and the clinical significance of the results. Tobevibart is a liver-targeted, small molecule designed to inhibit the entry and spread of hepatitis delta virus (HDV) within the liver. Elebsiran is an investigational RNA interference (RNAi) therapeutic that targets the expression of the hepatitis B surface antigen (HBsAg), which is essential for HDV replication. The combination therapy approach could offer a synergistic effect, potentially improving outcomes for patients with CHD.
The primary endpoints of a ≥ 2log10 decrease in HDV RNA or achieving HDV RNA below the limit of detection, along with normalization of alanine transaminase (ALT) levels, are important markers of treatment efficacy. A reduction in HDV RNA indicates a direct antiviral effect, while normalization of ALT levels suggests an improvement in liver inflammation and function. These endpoints are particularly relevant for patients with compensated cirrhosis, as they may indicate a reduction in the risk of disease progression to decompensated cirrhosis or hepatocellular carcinoma. The trial's design, which includes monotherapy and combination therapy arms, will provide insights into the optimal therapeutic approach for CHD.
03/05/2024 - 08:05 AM
– Over 60 participants dosed in two additional cohorts; initial data expected in the second quarter –
– Approximately 50% of participants have compensated cirrhosis –
SAN FRANCISCO --(BUSINESS WIRE)--
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.
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Source: Vir Biotechnology, Inc.
How many participants were dosed in the additional cohorts of the Phase 2 SOLSTICE trial by Vir Biotechnology (VIR)?
Over 60 participants were dosed in two additional cohorts of the Phase 2 SOLSTICE trial by Vir Biotechnology (VIR).
When is the initial data expected for the Phase 2 SOLSTICE trial by Vir Biotechnology (VIR)?
The initial data for the Phase 2 SOLSTICE trial by Vir Biotechnology (VIR) is expected in the second quarter of 2024.
What percentage of participants in the Phase 2 SOLSTICE trial by Vir Biotechnology (VIR) have compensated cirrhosis?
Approximately 50% of participants in the Phase 2 SOLSTICE trial by Vir Biotechnology (VIR) have compensated cirrhosis.
What are the primary endpoints of the Phase 2 SOLSTICE trial by Vir Biotechnology (VIR)?
The primary endpoints of the Phase 2 SOLSTICE trial by Vir Biotechnology (VIR) are the proportion of study participants achieving 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.
