– STRIVE is the first Phase 2 sub-protocol trial initiated under Vir’s new PREVAIL platform trial investigating the Company’s novel therapies in two chronic hepatitis B virus patient populations –
SAN FRANCISCO, May 11, 2023 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the first participant has been dosed in the Phase 2 STRIVE sub-protocol clinical trial evaluating the safety and efficacy of regimens containing combinations of VIR-3434, VIR-2218, pegylated interferon alpha (PEG-IFNα) and a nucleoside reverse transcriptase inhibitor (NRTI) in hepatitis B virus (HBV) immune-active, treatment-naïve adults. The STRIVE sub-protocol trial is the first to initiate under Vir’s new PREVAIL platform trial evaluating VIR-2218 and VIR-3434 with other therapies, including PEG-IFNα and an NRTI, in people at various stages of chronic HBV infection. Initial data from the STRIVE sub-protocol trial are expected in the first half of 2024.
“The initiation of our Phase 2 STRIVE sub-protocol trial marks an important clinical milestone in our pursuit of a functional cure for the nearly 300 million people worldwide living with chronic HBV,” said Carey Hwang, M.D., Ph.D., Vir’s Senior Vice President, Clinical Research, Head of Chronic Infection. “The PREVAIL platform trial and its sub-protocol trials uniquely enable the evaluation of our novel investigational medicines in distinct HBV patient populations – those with active viral replication and inflammation and those who are inactive carriers. We’re hopeful that the extensive evaluation of VIR-2218 and VIR-3434 will bring us closer to achieving a functional cure for a broad patient population with chronic HBV infection.”
The Company is also enrolling adults who are inactive carriers of HBV in its Phase 2 THRIVE sub-protocol clinical trial. Under the PREVAIL platform trial, the THRIVE sub-protocol trial will evaluate the safety and efficacy of regimens containing VIR-3434 and an NRTI with or without VIR-2218. Initial data from the THRIVE sub-protocol trial are expected in the first half of 2024.
VIR-2218 is an investigational subcutaneously administered small interfering ribonucleic acid (siRNA) that has the potential to stimulate an effective immune response and have direct antiviral activity against HBV and hepatitis D virus (HDV). VIR-3434 is an investigational HBsAg-targeting monoclonal antibody (mAb) engineered to potentially function as a T cell vaccine. VIR-3434 was identified using Vir’s proprietary mAb discovery platform that has previously yielded Ebanga and Xevudy as well as VIR-2482, an investigational mAb targeting influenza.
VIR-2218 and VIR-3434 are also being evaluated for the treatment of chronic HBV in adults who are already virally suppressed by an NRTI in the Phase 2 MARCH (Monoclonal Antibody siRNA Combination against Hepatitis B) trial. The initiation of the STRIVE sub-protocol trial is now one of five key combination trials underway as part of Vir’s broad HBV clinical program in pursuit of a functional cure.
About the PREVAIL Platform Trial
The PREVAIL platform trial (NCT05612581) is intended to evaluate the efficacy and safety of investigational therapies in participants with chronic HBV infection. The PREVAIL platform trial design allows for a modular approach with a master protocol that contains common elements shared across all sub-protocols. The sub-protocols define the interventions, patient population(s) and additional trial-specific elements. The adaptive design of this platform trial allows for evaluation of intervention(s) sequentially, in parallel or staggered to efficiently evaluate potential treatment regimens for achieving a functional cure for chronic HBV infection.
Design of the Phase 2 STRIVE Sub-Protocol Trial
STRIVE is a Phase 2 sub-protocol trial under the PREVAIL platform trial. The multi-center, open-label STRIVE sub-protocol trial is designed to evaluate the safety and efficacy of regimens containing VIR-3434, VIR-2218, PEG-IFNα and an NRTI in adults (age 18 to 66) with noncirrhotic chronic HBV infection (viremic) who have not received prior NRTI or PEG-IFNα treatment (immune-active, treatment-naïve). Patients who are HBeAg positive or negative with HBV DNA >2,000 IU/mL, ALT > ULN and ≤5x ULN may be eligible for this study. Up to 90 trial participants are planned to be enrolled to evaluate up to 48-week regimens of VIR-3434 and an NRTI, VIR-3434 and an NRTI in combination with VIR-2218, and VIR-3434 and an NRTI in combination with both VIR-2218 and PEG-IFNα. The primary endpoint of the STRIVE sub-protocol trial is the proportion of participants achieving suppression of HBV DNA with HBsAg loss at the end of treatment.
Design of the Phase 2 THRIVE Sub-Protocol Trial
THRIVE is a Phase 2 sub-protocol trial under the PREVAIL platform trial. The multi-center, open-label THRIVE sub-protocol trial is designed to evaluate the safety and efficacy of regimens containing VIR-3434, an NRTI and PEG-IFNα with or without VIR-2218 in adults (age 18 to 66) without cirrhosis who have low viral burden of chronic HBV infection (inactive carriers or immune-inactive). One of the largest groups of chronic HBV-infected patients, inactive carriers are defined by HBeAg negativity with sustained HBV DNA ≤2,000 IU/mL and ALT ≤ ULN. Up to 60 trial participants are planned to be enrolled to evaluate up to 48-week regimens of VIR-3434 and an NRTI with or without VIR-2218. The primary endpoint of the THRIVE sub-protocol trial is the proportion of participants achieving suppression of HBV DNA with HBsAg loss at the end of treatment.
About Chronic Hepatitis B
Chronic hepatitis B virus (HBV) infection remains an urgent global public health challenge associated with significant morbidity and mortality. Approximately 300 million people around the world are living with HBV, and approximately 900,000 of them die from associated complications each year. These patients are significantly underserved by existing therapies with low functional cure rates, lifelong daily therapy and poor tolerability. Vir is working to achieve a functional cure for the millions of people with HBV around the world through its broad and differentiated portfolio.
About VIR-2218
VIR-2218 is an investigational subcutaneously administered HBV-targeting siRNA that Vir believes has the potential to stimulate an effective immune response and have 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 could result in an increased therapeutic index. VIR-2218 is the first asset in the Company’s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical trials.
About VIR-3434
VIR-3434 is an investigational subcutaneously administered antibody designed to block entry of hepatitis B and hepatitis D viruses into hepatocytes and to reduce the level of virions and subviral particles in the blood. VIR-3434, which incorporates Xencor’s Xtend™ and other Fc technologies, has been engineered to potentially function as a T cell vaccine against HBV and HDV in infected patients, as well as to have an extended half-life.
About Vir Biotechnology
Vir Biotechnology is a commercial-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B and hepatitis D viruses, influenza A and human immunodeficiency virus. 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 clinical effects of VIR-2218, VIR-3434, VIR-2218 and VIR-3434 in combination with PEG-IFNα and an NRTI, and VIR-3434 and an NRTI with or without VIR-2218; the potential benefits, safety and efficacy of VIR-2218, VIR-3434, VIR-2218 and VIR-3434 in combination with PEG-IFNα and an NRTI, and VIR-3434 and an NRTI with or without VIR-2218; the timing, design and enrollment of the STRIVE sub-protocol trial and the THRIVE sub-protocol trial, including anticipated timing of data readouts; the design of the PREVAIL platform trial; the preliminary data of VIR-2218 in combination with PEG-IFNα; the initial results of the MARCH trial; Vir’s expectations related to the potential success of its current and future clinical development programs for HBV, including the PREVAIL platform trial; Vir’s plans and expectations for its HBV portfolio, including the PREVAIL platform trial; and risks and uncertainties associated with drug development and commercialization. Many important factors may cause differences between current expectations and actual results, including risks that Vir may not fully enroll the STRIVE sub-protocol trial or the THRIVE sub-protocol trial or it will take longer than expected; unexpected safety or efficacy data or results observed during the STRIVE sub-protocol trial, the THRIVE sub-protocol trial, the ongoing clinical trial of VIR-2218 in combination with PEG-IFNα, and the MARCH trial or in data readouts; the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; 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 the COVID-19 pandemic, 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.
