Pipeline
Our Pipeline
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 relapsing multiple sclerosis, and which has already shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis and other diseases;
- 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 comprises next-generation molecules in preclinical testing for neurologic, gastrointestinal and other autoimmune diseases leveraging Immunic’s Nurr1 platform.
Ongoing
Completed
In preparation or planned
Program: Vidofludimus Calcium (IMU-838)
Program: Izumerogant (IMU-935)
Patients in the United States
Patients in the United States
Relapsing Multiple Sclerosis
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 is a progressive disease which, without effective treatment, leads to severe disability.MS affects approximately one million people in the United States, and more than 2.8 million people, worldwide.[1] The disease has a large economic impact as it affects mainly young adults in the prime working age, peaking around 30 years old, although MS can occur at any age. MS affects twice as many women and men in certain age cohorts and is more common in areas inhabited by people of northern European ancestry, such as Europe, the United States, Canada, New Zealand and parts of Australia.[2]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.Progressive Multiple Sclerosis
Progressive multiple sclerosis, or PMS, includes 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. Active SPMS, the progressive disease form where relapses and MRI lesions are still present, is generally counted to the RMS spectrum. The forms of SPMS that are considered part of the PMS spectrum are non-active SPMS (where disability worsening occurs despite no relapses observed in the last 24 months and no MRI lesions present in the last 12 months) or non-relapsing SPMS (where no relapses occurred in the last 24 months, but MRI lesions may be present at any time).
Celiac Disease
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 impaired intestinal barrier function with villous atrophy and consecutive nutrient malabsorption.
Celiac disease is estimated to affect 1 in 100 people worldwide.[3] In the United States, alone, it is estimated that there are approximately two million people diagnosed with celiac disease and an additional approximately one million people are undiagnosed, yet still at risk for long-term health complications.[4, 5]
Ongoing inflammation in patients with celiac disease can cause debilitating symptoms and serious medical complications. Many patients suffer from gastrointestinal symptoms such as diarrhea and have abnormal bowel epithelial lining (villous atrophy and crypt enlargement). Small bowel damage often leads to nutrient malabsorption that can result in a range of further clinical manifestations such as fatigue, anemia, osteopenia, weight loss, or failure to thrive in children. In addition, extra-intestinal symptoms and systemic manifestations are often present, such as dermatitis herpetiformis, infertility, or neurological and skeletal disorders. Patients with persistent villous atrophy show an increased risk of lymphoproliferative malignancy. The intestinal epithelial barrier, physiologically impermeable to macromolecules such as gliadin, is recognized to play an important role in the pathogenesis of celiac disease. 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 medical 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.
- National Multiple Sclerosis Society. MS Prevalence FAQs. 2020. Available from: https://www.nationalmssociety.org/About-the-Society/MS-Prevalence/MS-Prevalence-FAQ
- National Multiple Sclerosis Society. Epidemiology and Causation. 2020. Available from: https://www.nationalmssociety.org/About-the-Society/MS-Prevalence/MS-Prevalence-FAQ
- 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