{"id":12861,"date":"2020-04-23T19:38:28","date_gmt":"2020-04-23T17:38:28","guid":{"rendered":"http:\/\/wordpress.p545550.webspaceconfig.de\/mediathek\/immunic-inc-reports-that-imu-838-a-selective-oral-dhodh-inhibitor-has-demonstrated-preclinical-activity-against-sars-cov-2\/"},"modified":"2020-09-16T16:38:43","modified_gmt":"2020-09-16T14:38:43","slug":"immunic-inc-reports-that-imu-838-a-selective-oral-dhodh-inhibitor-has-demonstrated-preclinical-activity-against-sars-cov-2","status":"publish","type":"gco_media","link":"https:\/\/www.izb-online.de\/en\/media-library\/immunic-inc-reports-that-imu-838-a-selective-oral-dhodh-inhibitor-has-demonstrated-preclinical-activity-against-sars-cov-2\/","title":{"rendered":"Immunic, Inc. Reports that IMU-838, a Selective Oral DHODH Inhibitor, Has Demonstrated Preclinical Activity Against SARS-CoV-2"},"content":{"rendered":"

[vc_row el_class=”gco-magazine-container”][vc_column el_class=”bildspalte”][vc_row_inner][vc_column_inner offset=”vc_col-lg-12 vc_col-md-12″][vc_column_text el_class=”gco-magazine–title”]<\/p>\n

Immunic, Inc. Reports that IMU-838, a Selective Oral DHODH Inhibitor, Has Demonstrated Preclinical Activity Against SARS-CoV-2<\/h1>\n

[\/vc_column_text][vc_column_text el_class=”gco-magazine-lead”]Immunic, Inc. Reports that IMU-838, a Selective Oral DHODH Inhibitor, Has Demonstrated Preclinical Activity Against SARS-CoV-2 and Explores Plans for a Phase 2 Clinical Trial in COVID-19 Patients<\/p>\n

\u2013\u00a0In Cellular Assays with SARS-CoV-2 Clinical Isolates, IMU-838 Shows Ability to\u00a0<\/em>Inhibit Viral Replication of SARS-CoV-2 \u2013<\/em><\/p>\n

\u2013 Live Webcast will be Held at 8:00am EST \/ 5:00am PST \/ 2:00pm CEST on\u00a0<\/em>Wednesday, April 22, 2020 \u2013<\/em>[\/vc_column_text][vc_column_text el_class=”gco-magazine–post-date”]23.04.2020[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner el_class=”gco-magazine-container–copy”][vc_column_inner width=”2\/3″ offset=”vc_col-lg-6 vc_col-md-6″][vc_column_text]<\/p>\n


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[\/vc_column_text][vc_column_text css=”.vc_custom_1583761043671{background-color: #1e73be !important;}” el_class=”redaktionell”][\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/3″ offset=”vc_col-lg-6 vc_col-md-6″][\/vc_column_inner][\/vc_row_inner][vc_row_inner el_class=”gco-magazine-container–copy”][vc_column_inner][vc_column_text]NEW YORK, April 21, 2020 \u2013 Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company\u00a0focused on developing best-in-class, oral therapies for the treatment of chronic inflammatory and\u00a0autoimmune diseases, today reported that its lead asset, IMU-838, a selective oral DHODH inhibitor, has\u00a0successfully demonstrated preclinical activity against severe acute respiratory syndrome coronavirus 2\u00a0(SARS-CoV-2). More specifically, IMU-838 was observed to inhibit replication of clinical isolates of SARSCoV-2 associated with coronavirus disease 2019 (COVID-19). In cellular assays, IMU-838 demonstrated\u00a0this antiviral activity at concentrations which are well below the blood concentrations associated with\u00a0IMU-838 dosing regimens studied in ongoing and previous clinical trials. These positive results have\u00a0encouraged Immunic to prepare a clinical development program for IMU-838 as a potential treatment\u00a0option for patients with COVID-19 and potential other, future viral pandemics.<\/strong><\/p>\n

\u201cThe current COVID-19 pandemic poses a major challenge to the healthcare community, worldwide, and it is essential to find safe and efficacious therapies,\u201d commented Prof. Maria Vehreschild, M.D., Head of\u2028Infectious Diseases at University Hospital Frankfurt. \u201cWhile most such efforts are focused on drugs and\u2028vaccines aimed at viral targets, it is particularly important to explore treatment options targeting host cell\u2028factors that are able to act with less dependence on the genetic drift of viruses and synergistically to\u2028standard-of-care antiviral therapies. With that in mind, DHODH inhibitors, such as IMU-838, present a\u2028very promising approach.\u201d<\/p>\n

Prof. Vehreschild went on to note that, \u201cDHODH inhibition selectively blocks the de novo production of\u2028pyrimidines, an essential RNA building block, in metabolically activated cells such as virus-infected cells.\u2028In addition, DHODH inhibitors may help reduce the severity or virulence of infection through several\u2028mechanisms. First, DHODH inhibition prevents the production of viral RNA and proteins and, therefore,\u2028prevents viral replication. Second, it induces innate immunity in an interferon independent setting as an\u2028early host-based antiviral response. Third, DHODH inhibition may ameliorate the overshooting immune\u2028response, as seen in severe COVID-19 cases, by selectively targeting highly activated immune cells, but\u2028without broader anti-proliferative or immunosuppressive effect.\u201d<\/p>\n

IMU-838 is already being investigated in ongoing phase 2 clinical trials in patients with relapsing-remitting\u2028multiple sclerosis, ulcerative colitis and primary sclerosing cholangitis. Although the drug is being studied\u2028in these ongoing trials primarily for its anti-inflammatory effect, one of IMU-838’s postulated benefits is\u2028a host-based antiviral effect, which may be important in these indications to potentially prevent virus\u2028reactivations known to occur with other immunomodulatory therapies. In support, IMU-838’s antiviral\u2028activity has previously been demonstrated in vitro against human immunodeficiency virus (HIV), hepatitis\u2028C virus (HCV), human cytomegalovirus (hCMV), Arenavirus and Influenza A virus. Given what is known\u2028about the natural course of the disease, IMU-838’s combination of antiviral activity against the highly\u2028pathogenic SARS-CoV-2 and a selective immunomodulatory effect against highly activated immune cells\u2028may be a promising profile for the treatment of COVID-19. Importantly, IMU-838 has an attractive\u2028pharmacokinetic, safety and tolerability profile and, to date, has already been tested in about 650\u2028individuals.<\/p>\n

\u201cThe broad antiviral activity of IMU-838 has been well documented and preclinical testing affirms the\u2028antiviral activity of IMU-838 against SARS-CoV-2. As a result, we are exploring the initiation of a phase 2\u2028clinical trial to determine if IMU-838 could be a meaningful therapeutic option for the current worldwide\u2028pandemic caused by COVID-19 and potential future pandemic threats,\u201d stated Daniel Vitt, Ph.D., Chief\u2028Executive Officer and President of Immunic. \u201cIn light of this recent data and the global health crisis caused\u2028by COVID-19, we view this strategic expansion of our core business focus as urgent and necessary.\u2028Implementation of this program requires a broad set of activities, and we are actively exploring additional\u2028sources to expand the current funding of this important new potential application for IMU-838. At the same\u2028time, we continue to progress our non-viral programs as previously planned.\u201d<\/p>\n

Management noted that Immunic is collaborating with several regulatory agencies and other institutions\u2028in the United States and in Europe to define and accelerate the development path for IMU-838 in COVID-\u202819. The aim is to investigate IMU-838 as an oral treatment option for COVID-19 and to enable the use of\u2028IMU-838 in treating current and potential future pandemic threats. Immunic intends to initiate a\u2028prospective, multicenter, randomized, placebo-controlled, double-blind phase 2 clinical trial in patients\u2028with moderate COVID-19 disease and clinical symptoms, in order to evaluate efficacy, safety and\u2028tolerability. The plan is to test IMU-838 versus placebo on the background of investigator\u2019s choice of\u2028standard-of-care therapy used in both treatment arms. Adequate drug supply exists to begin clinical\u2028testing in COVID-19 very soon.<\/p>\n

\u201cOur recent in vitro data confirms that IMU-838 may present a particularly promising approach for\u2028treating COVID-19, and even other, future viral pandemics,\u201d said Andreas Muehler, M.D., Chief Medical\u2028Officer of Immunic. \u201cGiven that IMU-838 targets a step performed by the infected host cell and not the\u2028virus itself, we believe that IMU-838 may also provide an approach that is relatively protected from the\u2028development of drug resistance. In COVID-19, this would also potentially allow to combine the host celltargeted\u2028treatment, IMU-838, with effective antiviral treatments. Based on our positive preclinical data,\u2028the fact that IMU-838 is a differentiated approach with potential for synergy with existing drugs, and its\u2028strong pharmacokinetic, safety and tolerability profile, we believe that IMU-838 is a particularly\u2028compelling candidate for development as a treatment option for COVID-19.\u201d<\/p>\n

In addition to IMU-838, Immunic also has several highly potent, antiviral drug candidates in early stages\u2028of development.<\/p>\n

About IMU-838\u2028<\/strong>
\nIMU-838 is an orally available, next-generation selective immune modulator that inhibits the intracellular\u2028metabolism of activated immune cells by blocking the enzyme dihydroorotate dehydrogenase (DHODH).\u2028IMU-838 acts on activated T and B cells while leaving other immune cells largely unaffected and allows\u2028the immune system to stay functioning, e.g. in fighting infections. In previous trials, IMU-838 did not show\u2028an increased rate of infections compared to placebo. In addition, DHODH inhibitors, such as IMU-838, are\u2028known to possess a host-based antiviral effect, which is independent with respect to specific virus proteins\u2028and their structure. Therefore, DHODH inhibition may be broadly applicable against multiple viruses. IMU-\u2028838 was successfully tested in two phase 1 clinical trials in 2017 and is currently being tested in phase 2\u2028trials in patients with relapsing-remitting multiple sclerosis and ulcerative colitis. IMU-838 is also under\u2028investigation as a potential treatment option for SARS-CoV-2 infections causing COVID-19. Furthermore,\u2028Immunic\u2019s collaboration partner, the Mayo Clinic, has started an investigator-sponsored proof-of-concept\u2028clinical trial testing IMU-838 activity in patients with primary sclerosing cholangitis.<\/p>\n

About Immunic, Inc.\u2028Immunic, Inc.<\/strong>
\n(Nasdaq: IMUX) is a clinical-stage biopharmaceutical company developing a pipeline of\u2028selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases,\u2028including relapsing-remitting multiple sclerosis, ulcerative colitis, Crohn\u2019s disease, and psoriasis. The\u2028company is developing three small molecule products: IMU-838 is a selective immune modulator that\u2028inhibits the intracellular metabolism of activated immune cells by blocking the enzyme DHODH; IMU-935\u2028is an inverse agonist of ROR\u03b3t; and IMU-856 targets the restoration of the intestinal barrier function.\u2028Immunic\u2019s lead development program, IMU-838, is in phase 2 clinical development for relapsing-remitting\u2028multiple sclerosis and ulcerative colitis, with an additional phase 2 trial considered in Crohn\u2019s disease. The\u2028company is also investigating IMU-838 as a potential treatment option for COVID-19. An investigatorsponsored\u2028proof-of-concept clinical trial for IMU-838 in primary sclerosing cholangitis is ongoing at the\u2028Mayo Clinic. For further information, please visit: www.imux.com<\/a>.<\/p>\n

Cautionary Statement Regarding Forward-Looking Statements\u2028<\/strong>
\nThis press release contains \u201cforward-looking statements\u201d that involve substantial risks and uncertainties\u2028for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All\u2028statements, other than statements of historical facts, included in this press release regarding strategy,\u2028future operations, future financial position, future revenue, projected expenses, prospects, plans and\u2028objectives of management are forward-looking statements. Examples of such statements include, but are\u2028not limited to, statements relating to Immunic\u2019s three development programs and the targeted diseases;\u2028the potential for IMU-838 to safely and effectively target diseases; preclinical and clinical data for IMU-\u2028838; the timing of current and future clinical trials; the potential for IMU-838 as a potential treatment for\u2028severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections causing coronavirus disease\u20282019 (COVID-19) and other viruses and any clinical trials, collaborations and approvals relating to such\u2028potential treatment; the nature, strategy and focus of the company; and the development and\u2028commercial potential of any product candidates of the company. Immunic may not actually achieve the\u2028plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking\u2028statements and you should not place undue reliance on these forward-looking statements. Such\u2028statements are based on management\u2019s current expectations and involve risks and uncertainties. Actual\u2028results and performance could differ materially from those projected in the forward-looking statements\u2028as a result of many factors, including, without limitation, risks and uncertainties associated with the ability\u2028to project future cash utilization and reserves needed for contingent future liabilities and business\u2028operations, the availability of sufficient resources to meet business objectives and operational\u2028requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical\u2028trial results, the protection and market exclusivity provided by Immunic\u2019s intellectual property, risks\u2028related to the drug development and the regulatory approval process and the impact of competitive\u2028products and technological changes. A further list and descriptions of these risks, uncertainties and other\u2028factors can be found in the section captioned \u201cRisk Factors,\u201d in the company\u2019s Annual Report on Form 10-\u2028K for the fiscal year ended December 31, 2019, filed with the SEC on March 16, 2020, and in the company\u2019s\u2028subsequent filings with the Securities and Exchange Commission. Copies of these filings are available\u2028online at www.sec.gov or ir.immunic-therapeutics.com\/sec-filings and on request from Immunic. Any\u2028forward-looking statement made in this release speaks only as of the date of this release. Immunic\u2028disclaims any intent or obligation to update these forward-looking statements to reflect events or\u2028circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability\u2028in respect to actions taken or not taken based on any or all the contents of this press release.<\/p>\n

Contact Information<\/strong><\/p>\n

Immunic, Inc.<\/strong>
\nJessica Breu
\nManager Investor Relations and Communications
\n+49 89 2080 477 09
\njessica.breu@imux.com<\/p>\n

US IR Contact<\/strong>
\nRx Communications Group
\nMelody Carey
\n+1-917-322-2571
\nimmunic@rxir.com<\/p>\n

US Media Contact<\/strong>
\nKnight Marketing Communications, Ltd.
\nKevin Knight
\n+1-206-451-4823
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