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IMMUNIC, INC. (IMUX)

Immunic, Inc. is a biopharmaceutical firm currently in the clinical development phase, dedicated to pioneering selective oral immunotherapies for a range of chronic inflammatory and autoimmune conditions. Its primary investigational compound, IMU-838, has advanced to Phase 2 clinical trials, targeting relapsing-remitting multiple sclerosis (RRMS), inflammatory bowel disease (IBD), various other chronic inflammatory and autoimmune disorders, and also coronavirus disease. Additionally, the company is advancing IMU-935, which functions as an inverse agonist of RORγt, and IMU-856, designed to restore the intestinal barrier for patients afflicted with conditions like inflammatory bowel disease, irritable bowel syndrome with diarrhea, immune checkpoint inhibitor-induced colitis, and other ailments affecting intestinal barrier integrity. The company's headquarters are located in New York, New York.

Sector: Pharmaceutical Preparations

Industry: Biotechnology

Immunic, Inc. logo

Immunic, Inc.

NASDAQ:IMUXHealthcare
-3.66%$7.51
AH$7.62+1.46%vs close
Mkt Cap$102.47M
Float–
O/S13.64M
Vol
$ Vol
RVOL
Inst Own62.3%
Earnings
Dilution
Upcoming Catalysts
Phase Distribution
17 lead-sponsored trials·3 active·5 completed
Phase 11
Phase 1/21
Phase 26
Phase 2/33
Phase 35
Not applicable1
(1 more as collaborator)

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 3
    Completed

    Assess Safety and Efficacy of ELAD (Extracorporeal Liver Assist System) in Subjects With Alcohol-Induced Liver Failure

    ELAD treatment

    Acute Alcoholic Hepatitis

    Enrollment
    203
    Start
    Feb 2013
    Primary Completion
    Jan 2015
    Completion
    Aug 2015
    NCT01471028
  • Phase 3
    Terminated

    To Assess Safety/Efficacy of ELAD in Subjects w/ Severe Acute Alcoholic Hepatitis (sAAH) and Lille Score Failure

    ELAD

    Severe Acute Alcoholic Hepatitis

    Enrollment
    18
    Start
    Apr 2014
    Primary Completion
    Oct 2015
    Completion
    Sep 2018
    NCT01829347
  • Phase 3
    Terminated

    Randomized, Open-Label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD in Subjects w/ AILD

    ELAD System

    Acute Alcoholic Hepatitis

    Enrollment
    151
    Start
    Jan 2016
    Primary Completion
    Mar 2018
    Completion
    Sep 2018
    NCT02612428
  • Phase 3
    Active, not recruiting

    Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis

    IMU-838 tablets, Placebo matching IMU-838 tablets

    Multiple Sclerosis

    Enrollment
    1,121
    Start
    Nov 2021
    Primary Completion
    Nov 2026est.
    Completion
    Sep 2033est.
    NCT05134441
  • Phase 3
    Active, not recruiting

    Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis

    IMU-838 tablets, Placebo matching IMU-838 tablets

    Multiple Sclerosis, Relapsing-Remitting

    Enrollment
    1,100
    Start
    Jan 2022
    Primary Completion
    Nov 2026est.
    Completion
    Oct 2033est.
    NCT05201638
  • Phase 2/3
    Completed

    Efficacy and Safety of the Extracorporeal Liver Assist Device (ELAD) in Acute on Chronic Hepatitis

    ELAD plus standard of care treatment

    Acute On Chronic Hepatitis

    Enrollment
    62
    Start
    Sep 2009
    Primary Completion
    Apr 2011
    Completion
    May 2011
    NCT00973817
  • Phase 2/3
    Withdrawn

    Registry Protocol for Tracking Trial Subjects After VTI-206 Study Completion

    ELAD (Extracorporeal Liver Assist System)

    Acute Liver Failure

    Enrollment
    0
    Start
    Jun 2010
    Primary Completion
    Sep 2012
    Completion
    Sep 2012
    NCT01452295
  • Phase 2/3
    Completed

    A Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 as Addition to Investigator's Choice of Standard of Care Therapy, in Patients With Coronavirus Disease 19 (COVID-19)

    IMU-838

    COVID-19

    Enrollment
    234
    Start
    Jun 2020
    Primary Completion
    Jan 2021
    Completion
    Feb 2021
    NCT04379271
  • Phase 2
    Completed

    Phase 2 Evaluation of the ELAD System in the Management of Acute Liver Failure

    ELAD

    Fulminant Hepatic Failure

    Enrollment
    19
    Start
    Jan 2002
    Primary Completion
    Feb 2003
    Completion
    Feb 2003
    NCT00030225
  • Phase 2
    Withdrawn

    Safety and Efficacy of the Extracorporeal Liver Assist Device (ELAD®) In Patients With Fulminant Hepatic Failure (FHF)

    Standard of Care, ELAD®

    Fulminant Hepatic Failure

    Enrollment
    0
    Start
    Mar 2009
    Primary Completion
    Sep 2011
    Completion
    Sep 2011
    NCT00832728
  • Phase 2
    Terminated

    Safety and Efficacy of the ELAD System (ELAD) to Treat Acute Liver Failure (ALF)

    ELAD

    Acute Liver Failure, Fulminant Hepatic Failure +2

    Enrollment
    8
    Start
    Oct 2014
    Primary Completion
    Sep 2015
    Completion
    Sep 2018
    NCT01875874
  • Phase 2
    Terminated

    Phase 2 Dose-finding IMU-838 for Ulcerative Colitis

    IMU-838, Placebo

    Ulcerative Colitis

    Enrollment
    263
    Start
    Mar 2018
    Primary Completion
    Nov 2022
    Completion
    Nov 2022
    NCT03341962
  • Phase 2
    Active, not recruiting

    MRI Trial to exPlore the efficAcy and Safety of IMU-838 in Relapsing Remitting Multiple Sclerosis (EMPhASIS)

    IMU-838 (30 mg/day), IMU-838 (45 mg/day)

    Relapsing-Remitting Multiple Sclerosis (RRMS)

    Enrollment
    210
    Start
    Jan 2019
    Primary Completion
    Apr 2020
    Completion
    Dec 2029est.
    NCT03846219
  • Phase 2
    Unknown status

    Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis

    IMU-838, Placebo matching IMU-838

    Multiple Sclerosis

    Enrollment
    450
    Start
    Sep 2021
    Primary Completion
    Jan 2025est.
    Completion
    Jan 2025est.
    NCT05054140
  • Phase 1/2
    Completed

    Safety & Efficacy of the Extracorporeal Liver Assist Device (ELAD) System in Patients With Hepatic Insufficiency

    ELAD plus standard of care treatment

    Acute Hepatitis, Chronic Hepatitis

    Enrollment
    18
    Start
    Oct 2008
    Primary Completion
    Apr 2009
    Completion
    Apr 2009
    NCT00771446
  • Phase 1
    Terminated

    IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer

    IMU-935

    Metastatic Castration Resistant Prostate Cancer

    Enrollment
    18
    Start
    Dec 2021
    Primary Completion
    May 2023
    Completion
    May 2023
    NCT05124795
  • Expanded access
    No longer available

    Use of the ELAD® in Patients With Liver Failure to Provide Expanded Access With Cost Recovery

    ELAD®

    Liver Failure

    Enrollment
    -
    Start
    -
    Primary Completion
    -
    Completion
    -
    NCT00832273