Immunic AG
Immunic Therapeutics Announces First Patient Enrolled in Phase 2 Clinical Trial of IMU-838, an Oral Therapy for Patients with Relapsing-Remitting Multiple Sclerosis
DGAP-News: Immunic AG / Key word(s): Study Immunic Therapeutics Announces First Patient Enrolled in Phase 2 Clinical Trial of IMU-838, an Oral Therapy for Patients with Relapsing-Remitting Multiple Sclerosis Planegg-Martinsried, Germany, February 26, 2019 – Immunic AG (Immunic), a privately held clinical-stage biotechnology company, today announced enrollment of the first patient in a phase 2 clinical study of IMU-838 for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS). IMU-838 is an orally available, next-generation selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme dihydroorotate dehydrogenase (DHODH). This phase 2 study is an international, multicenter, double-blind, placebo-controlled, randomized, parallel-group trial that is expected to enroll approximately 200 patients in more than 40 centers across four European countries. The study’s primary objective is to evaluate the dose response of 30 mg/day and 45 mg/day of IMU-838, once daily, for the treatment of RRMS based on magnetic resonance imaging (MRI) assessments. Patients enrolled in the trial will have shown disease activity based on clinical evidence of relapse and MRI criteria. The trial includes a blinded 24-week main treatment period with an optional extended treatment period to evaluate long-term safety and tolerability of IMU-838 that will be unblinded when all patients have completed the main treatment portion and the study database has been locked. The primary endpoint of the study is the cumulative number of combined unique active (CUA) MRI lesions, up to week 24. Daniel Vitt, Ph.D., Chief Executive Officer of Immunic, stated, “Enrollment of the first patient in this trial as planned and on schedule represents another key milestone for Immunic and demonstrates the ability of our company to effectively execute our drug development strategy. We had already advanced IMU-838 into a phase 2 trial for ulcerative colitis, so we are excited about its clinical testing in this additional patient population. This development further advances our goal of expanding the indications for which IMU-838 shows great promise for patients with chronic inflammatory and autoimmune diseases.” For more information on this clinical trial, please visit: www.clinicaltrials.gov, NCT03846219. About IMU-838 About Immunic AG Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements relating to Immunic AG, including statements about our three development programs and the targeted diseases, our plans for the development of for IMU-838, our existing and planned clinical trials and the clinical utility of Immunic’s therapeutic candidates and our pending transaction with Vital Therapies. Risks and uncertainties that may cause actual results to differ materially from those expressed or implied in any forward-looking statement include, but are not limited to: Immunic’s plans to develop and commercialize its product candidates, including IMU-838, IMU-935 and IMU-856; the timing of Immunic’s planned clinical trials; and the expected listing of Immunic, Inc. on NASDAQ. Forward-looking statements are identified by the use of forward-looking terminology including “believes,” “expects,” “may,” “will,” “should,” “seeks,” “intends,” “plans,” “pro forma,” “estimates,” or “anticipates” or the negative of these words and phrases or other variations of these words and phrases or comparable terminology. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These forward-looking statements should not be relied upon as predictions of future events as Immunic cannot assure investors that the events or circumstances reflected in these statements will be achieved or will occur. The forward-looking statements in this press release represent Immunic’s views as of the date of this press release. Immunic anticipates that subsequent events and developments will cause its views to change. Immunic may elect to update these forward-looking statements at some point in the future, however, it has no current intention of doing so except to the extent required by applicable law. Investors should, therefore, not rely on these forward-looking statements as representing Immunic’s views as of any date subsequent to the date of this press release. Additional Information about the Proposed Transaction between Vital Therapies, Inc. and Immunic AG and Where to Find It This communication does not constitute a solicitation of proxy, an offer to purchase or a solicitation of an offer to sell any securities. Vital Therapies and its executive officers and directors may be deemed to be participants in the solicitation of proxies from Vital Therapies’ stockholders with respect to the matters relating to the proposed transaction. Immunic may also be deemed a participant in such solicitation. Information regarding Vital Therapies’ executive officers and directors is available in Vital Therapies’ proxy statement on Schedule 14A for its 2018 annual meeting of stockholders, filed with the SEC on April 12, 2018. Information regarding any interest that Vital Therapies, Immunic or any of the executive officers or directors of Vital Therapies or Immunic may have in the transaction with Immunic is set forth in the final proxy statement/prospectus that Vital Therapies has filed with the SEC in connection with its stockholder vote on matters relating to the proposed transaction. Contact Information Or
26.02.2019 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG. |