Pipeline

Our Pipeline

Oral small molecule therapies for chronic inflammatory and autoimmune diseases

Immunic is pursuing clinical development of orally administered, small molecule programs, each of which has unique features intended to directly address the unmet needs of patients with serious chronic inflammatory and autoimmune diseases. These include:

  • the vidofludimus calcium (IMU-838) program, which is in phase 3 and phase 2 clinical development for patients with relapsing and progressive multiple sclerosis, or MS, respectively, and which has shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting MS, progressive MS and moderate-to-severe ulcerative colitis, or UC;
  • the IMU-856 program, which is targeted to regenerate bowel epithelium and restore intestinal barrier function, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, inflammatory bowel disease and Graft-versus-Host-Disease;
  • and the IMU-381 program, which is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases.

Ongoing

Completed

In preparation or planned

Program: Vidofludimus Calcium (IMU-838)

Indication: Relapsing Multiple Sclerosis
Indication: Progressive Multiple Sclerosis
Indication: Moderate-to-Severe Ulcerative Colitis

Program: Izumerogant (IMU-935)

Target: IL-17/RORyt
Indication: Psoriasis
Indication: Castration-Resistant Prostate Cancer

Program: IMU-856

Indication: Celiac Disease and Other Gastrointestinal Disorders

Program: IMU-381

Indication: Gastrointestinal Diseases
0
Multiple Sclerosis
Patients in the United States
0
Celiac Disease
Patients in the United States
More about the indications targeted
  1. National Multiple Sclerosis Society. MS Prevalence FAQs. 2020. Available from: https://www.nationalmssociety.org/About-the-Society/MS-Prevalence/MS-Prevalence-FAQ
  2. Green J, Dunn WH, Medical Review(s), Application Number: 202992Orig1s000, 25 August 2012. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202992Orig1s000StatR.pdf
  3. Burisch J, Munkholm P. The epidemiology of inflammatory bowel disease. Scand J Gastroenterol. 2015;50(8):942–51
  4. Hanauer SB. Inflammatory bowel disease: Epidemiology, pathogenesis, and therapeutic opportunities. Inflamm Bowel Dis. 2006;12:S3–9
  5. Burisch J, Jess T, Martinato M, Lakatos PL, ECCO -EpiCom. The burden of inflammatory bowel disease in Europe. J Crohns Colitis. 2013;7(4):322–37
  6. Longobardi T, Bernstein CN, Bitton A, Panaccione R, Glasgow K, Tolomiczenko G. The Burden of Inflammatory Bowel Disease (IBD) in Canada. In: Crohn’s and Colitis Foundation of Canada [conference paper]; 2014 June 10. Available from: https://www.researchgate.net/publication/216221892
  7. Kappelman MD, Rifas-Shiman SL, Kleinman K, Ollendorf D, Bousvaros A, Grand RJ, et al. The prevalence and geographic distribution of Crohn’s disease and ulcerative colitis in the United States. Clin Gastroenterol Hepatol. 2007;5(12):1424–9
  8. Celiac Disease Foundation. What is Celiac Disease? 2022. Available from:https://celiac.org/about-celiac-disease/what-is-celiac-disease/
  9. Singh et al. Global Prevalence of Celiac Disease: Systematic Review and Meta-analysis. Clinical Gastroenterology and Hepatology 2018;16:823–836
  10. Choung et al. Less hidden celiac disease but increased gluten avoidance without a diagnosis in the USA: Findings from the National Health and Nutrition Examination Surveys from 2009 to 2014. Mayo Clin Proc. 2016 Dec 5:S0025-6196(16)30634-6