Pipeline
Our Pipeline
Immunic is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases.
Immunic is focused on the development and potential commercialization of orally administered, small molecule programs with unique features intended to directly address the unmet needs of patients with neurologic and autoimmune diseases.
- The vidofludimus calcium (IMU-838) program is in phase 3 clinical development for patients with relapsing multiple sclerosis, with an additional phase 3 clinical trial in progressive multiple sclerosis planned to be initiated.
- Vidofludimus calcium has previously shown therapeutic activity in phase 2 clinical trials in patients with relapsing-remitting multiple sclerosis, progressive multiple sclerosis, and other diseases.
- Immunic’s development pipeline also includes earlier-stage programs, including IMU-381 and IMU-856, aimed at building a broader therapeutics platform addressing neurodegenerative and autoimmune diseases.
Ongoing
Completed
In preparation or planned
Program: Vidofludimus Calcium (IMU-838)
Relapsing Multiple Sclerosis: ENSURE-1
Relapsing Multiple Sclerosis: ENSURE-2
Progressive Multiple Sclerosis
Program: Izumerogant (IMU-935)
Target: IL-17/RORyt
Indication: Psoriasis
Indication: Castration-Resistant Prostate Cancer
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Diagnosed Relapsing MS Patients in the United States
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Diagnosed Progressive MS Patients in the United States
More About the
Indications Targeted
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 Multiple Sclerosis
Relapsing MS is the most common form of the disease. Approximately 85% of patients with MS are expected to develop relapsing MS, with some patients developing more progressive forms of the disease. In the United States, approximately 400,000 patients are estimated to be diagnosed with relapsing MS.[3]Relapsing MS 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 MS includes primary progressive MS, or PPMS, and secondary progressive MS, or SPMS. In the United States, approximately 150,000 patients are estimated to be diagnosed with progressive MS.[3]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 relapsing MS spectrum. The forms of SPMS that are considered part of the progressive MS 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).
- 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
- Multiple Sclerosis Disease Landscape and Forecast Research Report by Decision Resources Group Part of Clarivate and Immunic analysis