{"id":509680,"date":"2021-07-06T08:04:32","date_gmt":"2021-07-06T12:04:32","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/eiger-biopharmaceuticals-announces-first-patients-dosed-with-peginterferon-lambda-in-phase-3-together-study-of-newly-diagnosed-covid-19-outpatients\/"},"modified":"2021-07-06T08:04:32","modified_gmt":"2021-07-06T12:04:32","slug":"eiger-biopharmaceuticals-announces-first-patients-dosed-with-peginterferon-lambda-in-phase-3-together-study-of-newly-diagnosed-covid-19-outpatients","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/eiger-biopharmaceuticals-announces-first-patients-dosed-with-peginterferon-lambda-in-phase-3-together-study-of-newly-diagnosed-covid-19-outpatients\/","title":{"rendered":"Eiger BioPharmaceuticals Announces First Patients Dosed with Peginterferon Lambda in Phase 3 TOGETHER Study of Newly Diagnosed COVID-19 Outpatients"},"content":{"rendered":"
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– Lambda is administered as a one-time, outpatient, subcutaneous dose<\/h2>\n

PR Newswire<\/p>\n<\/p><\/div>\n

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\n PALO ALTO, Calif.<\/span>, July 6, 2021<\/span> \/PRNewswire\/ — Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the first patients were dosed with Peginterferon Lambda (Lambda) in the Phase 3 TOGETHER<\/i> platform study in outpatients with COVID-19.\u00a0 Lambda is administered as a convenient, one-time, subcutaneous dose. <\/p>\n

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\n \"Eiger
\n <\/a>\n <\/p>\n<\/p><\/div>\n

\n TOGETHER<\/i>\u00a0is a multi-center, investigator-sponsored, randomized, placebo-controlled Phase 3 study evaluating multiple therapeutics in newly diagnosed, outpatients with COVID-19.\u00a0 The primary endpoint is a clinical outcome comparing emergency room visits and\/or hospitalization in each active arm versus placebo.\u00a0 Each arm targets enrollment of up to 800 patients at high risk for developing complications from progression of COVID-19, with planned interim analyses for futility.\u00a0 <\/p>\n

“Effective treatments are desperately needed for newly diagnosed COVID-19 outpatients that can be quickly and easily administered upon diagnosis, outside the hospital,” said David Cory<\/span>, President and CEO of Eiger.\u00a0 “Lambda stimulates immune responses that are critical for the development of host protection during viral infections and may be ideal for addressing variants of SARS-CoV-2, which remain an ongoing concern with approved monoclonal antibodies and vaccines.\u00a0 We are excited to include Lambda in the TOGETHER<\/i> study and look forward to reporting results in the future.”<\/p>\n

For more information about the TOGETHER<\/i> platform study, please visit www.togethertrial.com<\/a>. <\/p>\n

\n About Peginterferon Lambda (Lambda)
<\/b>Lambda is a well-characterized, first-in-class, type III, well-tolerated interferon (IFN) that stimulates immune responses that are critical for the development of host protection during viral infections.\u00a0 Lambda targets type III IFN receptors which are distinct from the type I IFN receptors targeted by IFN alfa which are more ubiquitously distributed throughout the body.\u00a0 Lambda receptors are largely restricted to cells and tissues of epithelial origin, including respiratory epithelial cells, lending itself to less off target effects.<\/p>\n

Interferon lambda is critical for maintaining a balanced antiviral response in the respiratory tract.\u00a0 They are induced at lower viral burden to limit the initial infection, before type I IFNs, by inducing viral resistance to cells and helping them deal with the virus load.\u00a0 IFN lambda lacks the strong pro-inflammatory effects of type I IFNs and are tissue-protective and anti-inflammatory.\u00a0 Administration of IFN lambda has been shown to suppress viral replication without development of cytokine storms.<\/p>\n

Eiger is developing Lambda for the treatment of hepatitis delta virus (HDV) infection.\u00a0 Lambda has been administered to over 3,000 subjects in 23 clinical trials of HBV, HCV, HDV and COVID-19.\u00a0 Lambda is an investigational agent and not yet approved for any indication.\u00a0 Eiger has received Orphan Designation by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), and Fast Track and Breakthrough Therapy Designation by FDA for Lambda in HDV.<\/p>\n

Eiger licensed worldwide rights to Lambda from Bristol-Myers Squibb.<\/p>\n

\n About Eiger
<\/b>Eiger is a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases. <\/p>\n

Eiger’s lead clinical programs are focused on the development of foundational therapies for Hepatitis Delta Virus (HDV) infection, the most serious form of viral hepatitis, with two complementary HDV treatments.\u00a0 Lonafarnib is a first-in-class, oral prenylation inhibitor in a global Phase 3 trial.\u00a0 Peginterferon lambda is a first-in-class, type III, well-tolerated interferon entering Phase 3.<\/p>\n

Zokinvy\u00ae<\/sup> for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company’s first FDA approved product.\u00a0 A Marketing Authorization Application (MAA) is under review by the\u00a0European Medicines Agency\u00a0(EMA).\u00a0 <\/p>\n

For additional information about Eiger and its clinical programs, please visit\u00a0www.eigerbio.com<\/a>. <\/p>\n

\n Note Regarding Forward-Looking Statements
<\/b>This press release contains “forward-looking” statements that involve substantial risks and uncertainties.\u00a0 Words such as “will,” “may,” “continue,” “plan,” “expect,” “could,” “potential” and similar expressions are intended to identify forward-looking statements.\u00a0 These statements include those regarding the potential of Lambda to be an effective therapy for newly diagnosed outpatients with\u00a0COVID-19; the timing and results of the TOGETHER platform study; and the potential for success of any of our product candidates.\u00a0 These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success, including risks related to failure or delays in successfully initiating, enrolling or completing clinical studies, including the TOGETHER platform study; the risks that results obtained in clinical trials to date may not be inductive of results obtained in ongoing or future trials; the time-consuming and uncertain regulatory approval process; the sufficiency of\u00a0Eiger’s\u00a0cash resources; and other risks and uncertainties described in the “Risk Factors” sections in the Quarterly Report on Form 10-Q for the quarter ended\u00a0March 31, 2021\u00a0and\u00a0Eiger’s\u00a0subsequent filings with the SEC.\u00a0 The forward-looking statements contained in this press release are based on information currently available to Eiger and speak only as of the date on which they are made.\u00a0 Eiger does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise.<\/p>\n

\n

\n
Investors and Media: <\/p>\n

\n Charles Butler<\/span>
\n
VP, Investor Relations & Corporate Communications
Email: cbutler@eigerbio.com<\/a>
Phone: 1-650-272-6138 <\/p>\n

<\/div>\n

\n \"Cision\" View original content to download multimedia:https:\/\/www.prnewswire.com\/news-releases\/eiger-biopharmaceuticals-announces-first-patients-dosed-with-peginterferon-lambda-in-phase-3-together-study-of-newly-diagnosed-covid-19-outpatients-301325802.html<\/a><\/p>\n

SOURCE Eiger BioPharmaceuticals, Inc.<\/p>\n<\/p><\/div>\n

\"\"<\/p>\n","protected":false},"excerpt":{"rendered":"

– Lambda is administered as a one-time, outpatient, subcutaneous dose PR Newswire PALO ALTO, Calif., July 6, 2021 \/PRNewswire\/ — Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the first patients were dosed with Peginterferon Lambda (Lambda) in the Phase 3 TOGETHER platform study in outpatients with COVID-19.\u00a0 Lambda is administered as a convenient, one-time, subcutaneous dose. TOGETHER\u00a0is a multi-center, investigator-sponsored, randomized, placebo-controlled Phase 3 study evaluating multiple therapeutics in newly diagnosed, outpatients with COVID-19.\u00a0 The primary endpoint is a clinical outcome comparing emergency room visits and\/or hospitalization in each active arm versus placebo.\u00a0 Each arm targets enrollment of up to 800 … <\/p>\n

Continue reading “Eiger BioPharmaceuticals Announces First Patients Dosed with Peginterferon Lambda in Phase 3 TOGETHER Study of Newly Diagnosed COVID-19 Outpatients”<\/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-509680","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nEiger BioPharmaceuticals Announces First Patients Dosed with Peginterferon Lambda in Phase 3 TOGETHER Study of Newly Diagnosed COVID-19 Outpatients - 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\/eiger-biopharmaceuticals-announces-first-patients-dosed-with-peginterferon-lambda-in-phase-3-together-study-of-newly-diagnosed-covid-19-outpatients\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Eiger BioPharmaceuticals Announces First Patients Dosed with Peginterferon Lambda in Phase 3 TOGETHER Study of Newly Diagnosed COVID-19 Outpatients - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"– Lambda is administered as a one-time, outpatient, subcutaneous dose PR Newswire PALO ALTO, Calif., July 6, 2021 \/PRNewswire\/ — Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the first patients were dosed with Peginterferon Lambda (Lambda) in the Phase 3 TOGETHER platform study in outpatients with COVID-19.\u00a0 Lambda is administered as a convenient, one-time, subcutaneous dose. 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(Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the first patients were dosed with Peginterferon Lambda (Lambda) in the Phase 3 TOGETHER platform study in outpatients with COVID-19.\u00a0 Lambda is administered as a convenient, one-time, subcutaneous dose. TOGETHER\u00a0is a multi-center, investigator-sponsored, randomized, placebo-controlled Phase 3 study evaluating multiple therapeutics in newly diagnosed, outpatients with COVID-19.\u00a0 The primary endpoint is a clinical outcome comparing emergency room visits and\/or hospitalization in each active arm versus placebo.\u00a0 Each arm targets enrollment of up to 800 … Continue reading \"Eiger BioPharmaceuticals Announces First Patients Dosed with Peginterferon Lambda in Phase 3 TOGETHER Study of Newly Diagnosed COVID-19 Outpatients\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/eiger-biopharmaceuticals-announces-first-patients-dosed-with-peginterferon-lambda-in-phase-3-together-study-of-newly-diagnosed-covid-19-outpatients\/","og_site_name":"Market Newsdesk","article_published_time":"2021-07-06T12:04:32+00:00","og_image":[{"url":"https:\/\/mma.prnewswire.com\/media\/285009\/eiger_biopharmaceuticals_logo.jpg","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/eiger-biopharmaceuticals-announces-first-patients-dosed-with-peginterferon-lambda-in-phase-3-together-study-of-newly-diagnosed-covid-19-outpatients\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/eiger-biopharmaceuticals-announces-first-patients-dosed-with-peginterferon-lambda-in-phase-3-together-study-of-newly-diagnosed-covid-19-outpatients\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Eiger BioPharmaceuticals Announces First Patients Dosed with Peginterferon Lambda in Phase 3 TOGETHER Study of Newly Diagnosed COVID-19 Outpatients","datePublished":"2021-07-06T12:04:32+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/eiger-biopharmaceuticals-announces-first-patients-dosed-with-peginterferon-lambda-in-phase-3-together-study-of-newly-diagnosed-covid-19-outpatients\/"},"wordCount":899,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/eiger-biopharmaceuticals-announces-first-patients-dosed-with-peginterferon-lambda-in-phase-3-together-study-of-newly-diagnosed-covid-19-outpatients\/#primaryimage"},"thumbnailUrl":"https:\/\/mma.prnewswire.com\/media\/285009\/eiger_biopharmaceuticals_logo.jpg","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/eiger-biopharmaceuticals-announces-first-patients-dosed-with-peginterferon-lambda-in-phase-3-together-study-of-newly-diagnosed-covid-19-outpatients\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/eiger-biopharmaceuticals-announces-first-patients-dosed-with-peginterferon-lambda-in-phase-3-together-study-of-newly-diagnosed-covid-19-outpatients\/","name":"Eiger BioPharmaceuticals Announces First Patients Dosed with Peginterferon Lambda in Phase 3 TOGETHER Study of Newly Diagnosed COVID-19 Outpatients - 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