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.
- Cash runway at this date: 23mo
- Cash runway at this date: 2yr
Trials need funding. See this company's dilution risk and cash position.
- Phase 3Completed
Assess Safety and Efficacy of ELAD (Extracorporeal Liver Assist System) in Subjects With Alcohol-Induced Liver Failure
ELAD treatment
Acute Alcoholic Hepatitis
NCT01471028Enrollment203StartFeb 2013Primary CompletionJan 2015CompletionAug 2015 - Phase 3Terminated
To Assess Safety/Efficacy of ELAD in Subjects w/ Severe Acute Alcoholic Hepatitis (sAAH) and Lille Score Failure
ELAD
Severe Acute Alcoholic Hepatitis
NCT01829347Enrollment18StartApr 2014Primary CompletionOct 2015CompletionSep 2018 - Phase 3Terminated
Randomized, Open-Label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD in Subjects w/ AILD
ELAD System
Acute Alcoholic Hepatitis
NCT02612428Enrollment151StartJan 2016Primary CompletionMar 2018CompletionSep 2018 - Phase 3Active, 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
NCT05134441Enrollment1,121StartNov 2021Primary CompletionNov 2026est.CompletionSep 2033est. - Phase 3Active, 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
NCT05201638Enrollment1,100StartJan 2022Primary CompletionNov 2026est.CompletionOct 2033est. - Phase 2/3Completed
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
NCT00973817Enrollment62StartSep 2009Primary CompletionApr 2011CompletionMay 2011 - Phase 2/3Withdrawn
Registry Protocol for Tracking Trial Subjects After VTI-206 Study Completion
ELAD (Extracorporeal Liver Assist System)
Acute Liver Failure
NCT01452295Enrollment0StartJun 2010Primary CompletionSep 2012CompletionSep 2012 - Phase 2/3Completed
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
NCT04379271Enrollment234StartJun 2020Primary CompletionJan 2021CompletionFeb 2021 - Phase 2Completed
Phase 2 Evaluation of the ELAD System in the Management of Acute Liver Failure
ELAD
Fulminant Hepatic Failure
NCT00030225Enrollment19StartJan 2002Primary CompletionFeb 2003CompletionFeb 2003 - Phase 2Withdrawn
Safety and Efficacy of the Extracorporeal Liver Assist Device (ELAD®) In Patients With Fulminant Hepatic Failure (FHF)
Standard of Care, ELAD®
Fulminant Hepatic Failure
NCT00832728Enrollment0StartMar 2009Primary CompletionSep 2011CompletionSep 2011 - Phase 2Terminated
Safety and Efficacy of the ELAD System (ELAD) to Treat Acute Liver Failure (ALF)
ELAD
Acute Liver Failure, Fulminant Hepatic Failure +2
NCT01875874Enrollment8StartOct 2014Primary CompletionSep 2015CompletionSep 2018 - Phase 2Terminated
Phase 2 Dose-finding IMU-838 for Ulcerative Colitis
IMU-838, Placebo
Ulcerative Colitis
NCT03341962Enrollment263StartMar 2018Primary CompletionNov 2022CompletionNov 2022 - Phase 2Active, 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)
NCT03846219Enrollment210StartJan 2019Primary CompletionApr 2020CompletionDec 2029est. - Phase 2Unknown 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
NCT05054140Enrollment450StartSep 2021Primary CompletionJan 2025est.CompletionJan 2025est. - Phase 1/2Completed
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
NCT00771446Enrollment18StartOct 2008Primary CompletionApr 2009CompletionApr 2009 - Phase 1Terminated
IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer
IMU-935
Metastatic Castration Resistant Prostate Cancer
NCT05124795Enrollment18StartDec 2021Primary CompletionMay 2023CompletionMay 2023 - Expanded accessNo longer available
Use of the ELAD® in Patients With Liver Failure to Provide Expanded Access With Cost Recovery
ELAD®
Liver Failure
NCT00832273Enrollment-Start-Primary Completion-Completion-
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 3 | Completed | ELAD treatment | NCT01471028 |
| Phase 3 | Terminated | ELAD | NCT01829347 |
| Phase 3 | Terminated | ELAD System | NCT02612428 |
| Phase 3 | Active, not recruiting | IMU-838 tablets, Placebo matching IMU-838 tablets | NCT05134441 |
| Phase 3 | Active, not recruiting | IMU-838 tablets, Placebo matching IMU-838 tablets | NCT05201638 |
| Phase 2/3 | Completed | ELAD plus standard of care treatment | NCT00973817 |
| Phase 2/3 | Withdrawn | ELAD (Extracorporeal Liver Assist System) | NCT01452295 |
| Phase 2/3 | Completed | IMU-838 | NCT04379271 |
| Phase 2 | Completed | ELAD | NCT00030225 |
| Phase 2 | Withdrawn | Standard of Care, ELAD® | NCT00832728 |
| Phase 2 | Terminated | ELAD | NCT01875874 |
| Phase 2 | Terminated | IMU-838, Placebo | NCT03341962 |
| Phase 2 | Active, not recruiting | IMU-838 (30 mg/day), IMU-838 (45 mg/day) | NCT03846219 |
| Phase 2 | Unknown status | IMU-838, Placebo matching IMU-838 | NCT05054140 |
| Phase 1/2 | Completed | ELAD plus standard of care treatment | NCT00771446 |
| Phase 1 | Terminated | IMU-935 | NCT05124795 |
| Expanded access | No longer available | ELAD® | NCT00832273 |