{"id":794674,"date":"2024-12-12T16:12:15","date_gmt":"2024-12-12T21:12:15","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/vir-biotechnology-receives-fda-breakthrough-therapy-designation-and-ema-prime-designation-for-tobevibart-and-elebsiran-in-chronic-hepatitis-delta\/"},"modified":"2024-12-12T16:12:15","modified_gmt":"2024-12-12T21:12:15","slug":"vir-biotechnology-receives-fda-breakthrough-therapy-designation-and-ema-prime-designation-for-tobevibart-and-elebsiran-in-chronic-hepatitis-delta","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/vir-biotechnology-receives-fda-breakthrough-therapy-designation-and-ema-prime-designation-for-tobevibart-and-elebsiran-in-chronic-hepatitis-delta\/","title":{"rendered":"Vir Biotechnology Receives FDA Breakthrough Therapy Designation and EMA PRIME Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta"},"content":{"rendered":"

<\/p>\n

Vir Biotechnology Receives FDA Breakthrough Therapy Designation and EMA PRIME Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta<\/b><\/p>\n

\n\u2013 Designations aim to expedite the development and review of promising therapies for serious conditions with unmet medical needs \u2013<\/i><\/p>\n

\n\u2013 Phase 3 ECLIPSE registrational program in chronic hepatitis delta to begin in the first half of 2025 \u2013<\/i><\/p>\n

SAN FRANCISCO–(BUSINESS WIRE<\/a>)–
\nVir Biotechnology, Inc. (Nasdaq: VIR) today announced that tobevibart and elebsiran have received U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation and European Medicines Agency (EMA) Priority Medicines (PRIME) designation for the treatment of chronic hepatitis delta (CHD). The designations are supported by compelling positive safety and efficacy data from the Phase 2 SOLSTICE trial, from which the Company recently presented new data<\/a> at AASLD The Liver Meeting\u00ae<\/sup> in San Diego, U.S. Vir Biotechnology\u2019s Phase 3 ECLIPSE registrational program evaluating tobevibart and elebsiran in CHD will commence in the first half of 2025.<\/p>\n

\nCHD is a chronic, progressive liver disease caused by the hepatitis delta virus1<\/sup> and is the most severe form of chronic viral hepatitis2<\/sup>. CHD increases the risk of liver cancer and accelerates progression to cirrhosis and liver failure, which often occurs within 5 years of infection3<\/sup>. There is no approved treatment in the U.S., and options are limited in the European Union and globally.<\/p>\n

\n\u201cChronic hepatitis delta has devastating effects on liver and overall health, yet people living with this condition are still waiting for highly effective therapeutic options,\u201d said Mark Eisner, M.D., M.P.H., Executive Vice President and Chief Medical Officer, Vir Biotechnology. \u201cThe Phase 2 SOLSTICE trial data suggests that tobevibart and elebsiran can rapidly and deeply suppress the hepatitis delta virus, driving it to undetectable levels. Receiving FDA Breakthrough Therapy and European PRIME designations recognizes this combination\u2019s potential to transform the lives of people living with CHD. We look forward to advancing the Phase 3 ECLIPSE program as quickly as possible.\u201d<\/p>\n

\nFDA Breakthrough Therapy designation aims to expedite the development and regulatory reviews of investigational therapies for serious conditions that demonstrate promising preliminary clinical evidence and potential improvement over existing therapies. EMA PRIME designation is granted to investigational medicines that target conditions with unmet medical needs for which no treatment option exists, or where they can offer a major therapeutic advantage over existing treatments. It fosters early exchange with the EMA to facilitate robust data collection, high-quality marketing authorization applications and expedited evaluations so that medicines can reach patients earlier. These designations follow FDA Fast Track designation<\/a> and EMA Committee for Orphan Medicinal Products (COMP) positive opinion<\/a> on orphan drug designation received earlier this year.<\/p>\n

About the Phase 2 SOLSTICE Trial<\/b><\/p>\n

\nSOLSTICE is a Phase 2 study to evaluate the safety, tolerability, and efficacy of tobevibart, alone or in combination with elebsiran, in patients with chronic hepatitis delta. This Phase 2 study is a multi-center, open-label, randomized study. Primary endpoints include proportion of participants with undetectable hepatitis delta virus (HDV) RNA (defined as HDV RNA equal or greater than 2 log10<\/sub> decrease from baseline or below limit of detection) up to week 24, alanine aminotransferase (ALT) normalization (defined as ALT below upper limit of normal) up to week 24, and treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) up to 118 weeks. Secondary endpoints include proportion of participants with undetectable HDV RNA and different timepoints and up to 192 weeks. More information about this trial can be found at clinicaltrials.gov<\/a> (NCT05461170).<\/p>\n

About Tobevibart and Elebsiran<\/b><\/p>\n

\nTobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen. 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, which incorporates Xencor\u2019s Xtend\u2122 and other Fc technologies, has been engineered to have an extended half-life and was identified using Vir Biotechnology\u2019s proprietary monoclonal antibody discovery platform. Tobevibart is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis B and patients with chronic hepatitis delta.<\/p>\n

\nElebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) 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 B and patients with chronic hepatitis delta. It is the first asset in Vir Biotechnology\u2019s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical studies.<\/p>\n

About Vir Biotechnology, Inc.<\/b><\/p>\n

\nVir 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 double-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.<\/p>\n

References:
\n
<\/span>1 <\/sup>NIH National Institute of Diabetes and Digestive and Kidney Diseases Hepatitis D – NIDDK (nih.gov)<\/a>, accessed September 2024.
\n
2 <\/sup>WHO Hepatitis Delta Factsheet – Hepatitis D (who.int)<\/a>, accessed September 2024.
\n
3 <\/sup>CDC What is Hepatitis D – FAQ | CDC<\/a>.<\/p>\n

Forward-Looking Statements<\/b><\/p>\n

\nThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as \u201cmay,\u201d \u201cwill,\u201d \u201cplan,\u201d \u201cpotential,\u201d \u201caim,\u201d \u201cexpect,\u201d \u201canticipate,\u201d \u201cpromising\u201d 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 Biotechnology\u2019s 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 Biotechnology\u2019s strategy and plans, the potential clinical effects of tobevibart and elebsiran, the potential benefits, safety and efficacy of tobevibart and elebsiran, the timing, nature and significance of data from Vir Biotechnology\u2019s multiple ongoing trials evaluating tobevibart and elebsiran, Vir Biotechnology\u2019s plans and expectations for its CHD and CHB programs, and risks and uncertainties associated with drug development and commercialization. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data or results observed during clinical trials 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 Biotechnology\u2019s competitors; changes in expected or existing competition; delays in or disruptions to Vir Biotechnology\u2019s 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 Biotechnology\u2019s filings with the U.S. Securities and Exchange Commission, including the section titled \u201cRisk Factors\u201d contained therein. Except as required by law, Vir Biotechnology assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.<\/p>\n

\"\"<\/p>\n

View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20241212919029\/en\/<\/a><\/span><\/p>\n

Media
\n<\/b>
Arran Attridge
\n
Senior Vice President, Corporate Communications
\n
aattridge@vir.bio<\/a><\/p>\n

Investors
\n<\/b>
Richard Lepke
\n
Senior Director, Investor Relations
\n
rlepke@vir.bio<\/a><\/p>\n

KEYWORDS:<\/b> California United States North America<\/p>\n

INDUSTRY KEYWORDS:<\/b> Research Infectious Diseases FDA Clinical Trials Biotechnology AIDS General Health Pharmaceutical Health Science<\/p>\n

MEDIA:<\/b><\/p>\n\n\n\n\n
Logo<\/b><\/font><\/td>\n<\/tr>\n
\"Logo\"<\/td>\n<\/tr>\n
<\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Vir Biotechnology Receives FDA Breakthrough Therapy Designation and EMA PRIME Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta \u2013 Designations aim to expedite the development and review of promising therapies for serious conditions with unmet medical needs \u2013 \u2013 Phase 3 ECLIPSE registrational program in chronic hepatitis delta to begin in the first half of 2025 \u2013 SAN FRANCISCO–(BUSINESS WIRE)– Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that tobevibart and elebsiran have received U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation and European Medicines Agency (EMA) Priority Medicines (PRIME) designation for the treatment of chronic hepatitis delta (CHD). The designations are supported by compelling positive safety and efficacy data from the Phase 2 SOLSTICE trial, from which the … <\/p>\n

Continue reading “Vir Biotechnology Receives FDA Breakthrough Therapy Designation and EMA PRIME Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-794674","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nVir Biotechnology Receives FDA Breakthrough Therapy Designation and EMA PRIME Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/vir-biotechnology-receives-fda-breakthrough-therapy-designation-and-ema-prime-designation-for-tobevibart-and-elebsiran-in-chronic-hepatitis-delta\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Vir Biotechnology Receives FDA Breakthrough Therapy Designation and EMA PRIME Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Vir Biotechnology Receives FDA Breakthrough Therapy Designation and EMA PRIME Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta \u2013 Designations aim to expedite the development and review of promising therapies for serious conditions with unmet medical needs \u2013 \u2013 Phase 3 ECLIPSE registrational program in chronic hepatitis delta to begin in the first half of 2025 \u2013 SAN FRANCISCO–(BUSINESS WIRE)– Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that tobevibart and elebsiran have received U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation and European Medicines Agency (EMA) Priority Medicines (PRIME) designation for the treatment of chronic hepatitis delta (CHD). 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(Nasdaq: VIR) today announced that tobevibart and elebsiran have received U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation and European Medicines Agency (EMA) Priority Medicines (PRIME) designation for the treatment of chronic hepatitis delta (CHD). The designations are supported by compelling positive safety and efficacy data from the Phase 2 SOLSTICE trial, from which the … Continue reading \"Vir Biotechnology Receives FDA Breakthrough Therapy Designation and EMA PRIME Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/vir-biotechnology-receives-fda-breakthrough-therapy-designation-and-ema-prime-designation-for-tobevibart-and-elebsiran-in-chronic-hepatitis-delta\/","og_site_name":"Market Newsdesk","article_published_time":"2024-12-12T21:12:15+00:00","og_image":[{"url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20241212919029r1&sid=flmnd&distro=nx&lang=en","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"7 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/vir-biotechnology-receives-fda-breakthrough-therapy-designation-and-ema-prime-designation-for-tobevibart-and-elebsiran-in-chronic-hepatitis-delta\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/vir-biotechnology-receives-fda-breakthrough-therapy-designation-and-ema-prime-designation-for-tobevibart-and-elebsiran-in-chronic-hepatitis-delta\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Vir Biotechnology Receives FDA Breakthrough Therapy Designation and EMA PRIME Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta","datePublished":"2024-12-12T21:12:15+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/vir-biotechnology-receives-fda-breakthrough-therapy-designation-and-ema-prime-designation-for-tobevibart-and-elebsiran-in-chronic-hepatitis-delta\/"},"wordCount":1351,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/vir-biotechnology-receives-fda-breakthrough-therapy-designation-and-ema-prime-designation-for-tobevibart-and-elebsiran-in-chronic-hepatitis-delta\/#primaryimage"},"thumbnailUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20241212919029r1&sid=flmnd&distro=nx&lang=en","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/vir-biotechnology-receives-fda-breakthrough-therapy-designation-and-ema-prime-designation-for-tobevibart-and-elebsiran-in-chronic-hepatitis-delta\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/vir-biotechnology-receives-fda-breakthrough-therapy-designation-and-ema-prime-designation-for-tobevibart-and-elebsiran-in-chronic-hepatitis-delta\/","name":"Vir Biotechnology Receives FDA Breakthrough Therapy Designation and EMA PRIME Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta - 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