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 clinical development for patients with multiple sclerosis, or MS, and which has shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting MS and moderate-to-severe ulcerative colitis, or UC;
- the IMU-856 program, which is targeted to restore intestinal barrier function and regenerate bowel epithelium, which would be applicable in numerous gastrointestinal diseases, such as celiac disease, ulcerative colitis, Crohn’s disease, or irritable bowel syndrome with diarrhea;
- and the IMU-381 program, which is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases.
Completed or ongoing
In preparation or planned
Patients in the United States
Patients in the United States
Multiple sclerosis, or MS, is an autoimmune disease that affects the brain, spinal cord and optic nerve. In MS, myelin, the coating that protects the nerves, is attacked and damaged by the immune system. Thus, MS is considered an immune-mediated demyelinating disease of the central nervous system. MS affects approximately one million people in the United States, and more than 2.8 million people, worldwide. The disease has a large economic impact as it affects mainly young adults in the prime working age, although MS can occur at any age. MS is up to three times more common in women than in men.
Relapsing MS, or RMS, is the most common form of the disease. Approximately 85% of patients with MS are expected to develop RMS, with some patients developing more progressive forms of the disease. RMS is characterized by clearly defined attacks of new or increasing neurologic symptoms. These relapses are followed by periods of remission, or partial or complete recovery. During remissions, all symptoms may disappear, or some symptoms may continue and become permanent. MS is a progressive disease which, without effective treatment, leads to severe disability.
Progressive MS, or PMS, includes both primary progressive MS, or PPMS, and secondary progressive MS, or SPMS. PPMS is characterized by steadily worsening neurologic function from the onset of symptoms without initial relapse or remissions. SPMS is identified following an initial relapsing remitting course, after which the disease becomes more steadily progressive, with or without other disease activity present.
Ulcerative colitis, or UC, is most commonly diagnosed in late adolescence or early adulthood, but it can occur at any age. The occurrence of UC worldwide has increased over the past few years, particularly in Latin America, Asia and Eastern Europe. Recent estimates note that there are more than 700,000 patients affected by UC in the United States, as well as 1.5 million in Europe and more than 100,000 in Canada. UC is almost equally distributed between genders.
UC is a chronic inflammatory disease characterized by diffuse inflammation of the mucosa of the colon and rectum. The hallmark clinical symptoms of UC are diarrhea and bloody stool, and its clinical course is marked by exacerbations and remissions, which may occur spontaneously or in response to treatment changes or intercurrent illnesses.
Celiac disease is a multifactorial, complex autoimmune disease caused by an inappropriate immune reaction against a degradation product of gluten in genetically susceptible individuals. It is characterized by epithelial injury of the small intestine, elevated intestinal permeability, and nutrient malabsorption. Celiac disease causes debilitating signs and symptoms of malabsorption such as diarrhea, steatorrhea, fatigue, weight loss, anemia, and osteopenia, and can lead to serious complications such as enteropathy-associated T-cell lymphoma. In children, nutrient malabsorption can affect growth and development, in addition to causing the symptoms seen in adults.
There is currently no known cure or treatment for celiac disease and patients must adhere to a strict, life-long gluten-free diet which can help manage symptoms and avoid disease flareups.
Celiac disease is estimated to affect 1 in 100 people, worldwide. In the United States, alone, it is estimated that approximately one million people are undiagnosed and are, therefore, at risk for long-term health complications.[9, 10]
- National Multiple Sclerosis Society. MS Prevalence FAQs. 2020. Available from: https://www.nationalmssociety.org/About-the-Society/MS-Prevalence/MS-Prevalence-FAQ
- 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
- Burisch J, Munkholm P. The epidemiology of inflammatory bowel disease. Scand J Gastroenterol. 2015;50(8):942–51
- Hanauer SB. Inflammatory bowel disease: Epidemiology, pathogenesis, and therapeutic opportunities. Inflamm Bowel Dis. 2006;12:S3–9
- 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
- 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
- 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
- Celiac Disease Foundation. What is Celiac Disease? 2022. Available from:https://celiac.org/about-celiac-disease/what-is-celiac-disease/
- Singh et al. Global Prevalence of Celiac Disease: Systematic Review and Meta-analysis. Clinical Gastroenterology and Hepatology 2018;16:823–836
- 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