- |||||||||| Remicade (infliximab) / Merck (MSD), Mitsubishi Tanabe, J&J, Humira (adalimumab) / Eisai, AbbVie, vidofludimus (IMU-838) / Immunic
IMU-838, a Small Molecule DHODH Inhibitor in Phase 2 Clinical Trial for Ulcerative Colitis, Shows Potent Anti-inflammatory Activity in Cell-Culture-Based and In Vivo Systems (Virtual Poster exhibition) - Dec 29, 2021 - Abstract #ECCOIBD2022ECCO_IBD_784; DHODH is only important in cells that received a strong stimulus and are highly metabolically active. Therefore, IMU-838 will only specifically target these cells and will still allow for a normal immune response, representing a huge safety advantage for treatment of IBD patients.
- |||||||||| izumerogant (IMU-935) / Immunic
Enrollment open, Metastases: IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - Dec 28, 2021 P1, N=42, Recruiting, Therefore, IMU-838 will only specifically target these cells and will still allow for a normal immune response, representing a huge safety advantage for treatment of IBD patients. Not yet recruiting --> Recruiting
- |||||||||| BAY2402234 / Bayer, setanaxib (GKT831) / Calliditas, vidofludimus (IMU-838) / Immunic
Preclinical, Journal: A Bioluminescent 3CL Activity Assay to Monitor SARS-CoV-2 Replication and Identify Inhibitors. (Pubmed Central) - Oct 15, 2021 The anti-SARS-CoV-2 activity of Setanaxib was further confirmed using ACE2-expressing human pulmonary cells Beas2B as well as human primary nasal epithelial cells. Altogether, these results validate our cell-based functional assay and the interest of screening libraries of different origins to identify inhibitors of SARS-CoV-2 for drug repurposing or development.
- |||||||||| vidofludimus (IMU-838) / Immunic
P2 data, Journal: IMU-838, a Developmental DHODH Inhibitor in Phase II for Autoimmune Disease, Shows Anti-SARS-CoV-2 and Broad-Spectrum Antiviral Efficacy In Vitro. (Pubmed Central) - Dec 31, 2020 By the use of SARS-CoV-2-specific immunofluorescence, Western blot, in-cell ELISA, viral yield reduction and RT-qPCR methods, we demonstrated the following: (i) IMU-838 and back-ups show anti-SARS-CoV-2 activity at several levels of viral replication, i.e., protein production, double-strand RNA synthesis, and release of infectious virus; (ii) antiviral efficacy in Vero cells was demonstrated in a micromolar range (IMU-838 half-maximal effective concentration, EC of 7.6 ± 5.8 µM); (iii) anti-SARS-CoV-2 activity was distinct from cytotoxic effects (half-cytotoxic concentration, CC >100 µM); (iv) the drug in vitro potency was confirmed using several Vero lineages and human cells; (v) combination with remdesivir showed enhanced anti-SARS-CoV-2 activity; (vi) vidofludimus, the active determinant of IMU-838, exerted a broad-spectrum activity against a selection of major human pathogenic viruses. These findings strongly suggest that developmental DHODH inhibitors represent promising candidates for use as anti-SARS-CoV-2 therapeutics.
- |||||||||| vidofludimus (IMU-838) / Immunic
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: Vidofludimus Calcium for Primary Sclerosing Cholangitis (clinicaltrials.gov) - Nov 25, 2020 P2, N=14, Completed, These findings strongly suggest that developmental DHODH inhibitors represent promising candidates for use as anti-SARS-CoV-2 therapeutics. Recruiting --> Completed | N=30 --> 14 | Trial completion date: Nov 2020 --> Jun 2020 | Trial primary completion date: Oct 2020 --> Jun 2020
- |||||||||| vidofludimus (IMU-838) / Immunic
Journal: Repositioning an Immunomodulatory Drug Vidofludimus as a Farnesoid X Receptor Modulator With Therapeutic Effects on NAFLD. (Pubmed Central) - Jun 3, 2020 Notably, vidofludimus also possesses remarkable beneficial effects in reducing NAFLD by targeting FXR, which may represent a unique approach in developing the treatment for NAFLD. Our findings not only reveal a promising template for the design of novel FXR ligands in treating autoimmune disorders, but also uncover a novel therapeutic effect for vidofludimus on NAFLD based on the newly established relationships among drugs, targets, and diseases.
- |||||||||| vidofludimus (IMU-838) / Immunic
Trial primary completion date: Vidofludimus Calcium for Primary Sclerosing Cholangitis (clinicaltrials.gov) - May 31, 2020 P2, N=30, Recruiting, Our findings not only reveal a promising template for the design of novel FXR ligands in treating autoimmune disorders, but also uncover a novel therapeutic effect for vidofludimus on NAFLD based on the newly established relationships among drugs, targets, and diseases. Trial primary completion date: Apr 2020 --> Oct 2020
- |||||||||| vidofludimus (IMU-838) / Immunic
Enrollment closed, Trial completion date, Trial primary completion date, MRI: MRI Trial to exPlore the efficAcy and Safety of IMU-838 in Relapsing Remitting Multiple Sclerosis (EMPhASIS) (clinicaltrials.gov) - May 5, 2020 P2, N=210, Active, not recruiting, BDOs are a novel technology to study pathogenic biliary-immune cell interactions, and a personalized drug-testing platform in human PSC. Recruiting --> Active, not recruiting | Trial completion date: Jun 2030 --> Dec 2029 | Trial primary completion date: Nov 2020 --> May 2020
- |||||||||| vidofludimus (IMU-838) / Immunic
Enrollment change, Trial completion date, Trial primary completion date: CALDOSE-1: Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (clinicaltrials.gov) - Jan 9, 2020 P2, N=240, Recruiting, EMPhASIS is a Phase II trial investigating the efficacy and safety of the second generation DHODH inhibitor in patients with relapsing remitting MS. N=150 --> 240 | Trial completion date: Dec 2027 --> Jun 2029 | Trial primary completion date: Jan 2021 --> Jul 2022
- |||||||||| vidofludimus (IMU-838) / Immunic
Enrollment open: Vidofludimus Calcium for Primary Sclerosing Cholangitis (clinicaltrials.gov) - Dec 11, 2019 P2, N=30, Recruiting, N=150 --> 240 | Trial completion date: Dec 2027 --> Jun 2029 | Trial primary completion date: Jan 2021 --> Jul 2022 Not yet recruiting --> Recruiting
- |||||||||| Xeljanz (tofacitinib) / Pfizer
Review, Journal: Review article: novel oral-targeted therapies in inflammatory bowel disease. (Pubmed Central) - Sep 18, 2019 This is potentially the start of an exciting new era in which multiple therapeutic options are at the disposal of physicians to treat IBD on an individualised basis. Head-to-head studies with existing treatments and longer term safety data are needed for this to be possible.
- |||||||||| Remicade (infliximab) / Mitsubishi Tanabe, J&J, vidofludimus (IMU-838) / Immunic
PRECLINICAL INVESTIGATIONS OF IMU-838, AN ORALLY AVAILABLE SMALL MOLECULE INHIBITOR OF DIHYDROOROTATE DEHYDROGENASE FOR THE TREATMENT OF INFLAMMATORY BOWEL DISEASE (Poster Exhibition - Hall 7) - Aug 18, 2019 - Abstract #UEGW2019UEGW_2420; Beside the already known inhibition of IL-17 and IFNg cytokine secretion as well as apoptosis induction of highly activated T cells, these recent investigations of IMU838 also indicate a beneficial impact on regulatory macrophages and inhibition of. In addition, combining IMU-838 with an anti-TNFa antibody has shown a strong synergism of effects on regulatory macrophages and TNFa secretion, which seems to indicate that a combination trial in IBD patients suffering from insufficient or reduced efficacy of anti-TNFa antibodies such as infliximab should be considered.
- |||||||||| vidofludimus (IMU-838) / Immunic
Enrollment open: CALDOSE-1: Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (clinicaltrials.gov) - Mar 29, 2018 P2, N=150, Recruiting, In addition, combining IMU-838 with an anti-TNFa antibody has shown a strong synergism of effects on regulatory macrophages and TNFa secretion, which seems to indicate that a combination trial in IBD patients suffering from insufficient or reduced efficacy of anti-TNFa antibodies such as infliximab should be considered. Not yet recruiting --> Recruiting
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