Immunic Therapeutics is focused on developing innovative oral therapies for chronic inflammatory and autoimmune diseases, with a particular emphasis on multiple sclerosis (MS) and celiac disease. Their lead candidate, Vidofludimus Calcium (IMU-838), is a small molecule investigational drug designed to address multiple aspects of MS pathology. It operates through a unique mechanism that includes neuroprotective, anti-inflammatory, and anti-viral effects. By activating the neuroprotective transcription factor Nurr1, Vidofludimus Calcium aims to protect neurons from degeneration while selectively targeting hyperactive immune cells to reduce inflammation without compromising normal immune function. This dual action is intended to improve patient outcomes by potentially reducing relapses and disability progression associated with MS.

In addition to its application in MS, Immunic is also exploring Vidofludimus Calcium as a treatment for celiac disease, aiming to provide patients with effective and well-tolerated oral options. The company is conducting multiple clinical trials, including phase 3 studies for relapsing MS and phase 2 trials for progressive MS, to evaluate the efficacy and safety of their therapies. The promising results from these trials suggest that Vidofludimus Calcium could offer a distinctive therapeutic approach that aligns with the biological drivers of MS, potentially leading to improved quality of life for patients suffering from these debilitating conditions.

United States

Immunic, Inc. (Nasdaq: IMUX) is a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases including relapsing-remitting multiple sclerosis, ulcerative colitis, Crohn’s disease, and psoriasis. 

Digestive System Diseases

Immune System Diseases

Inflammatory disorders

Nervous System Diseases

Immunic

Autoimmune disease

Multiple sclerosis

IMU-838 is an orally available, next-generation selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme dihydroorotate dehydrogenase (DHODH). IMU-838 acts on activated T and B cells while leaving other immune cells largely unaffected and allows the immune system to stay functioning, e.g. in fighting infections. In previous trials, IMU-838 did not show an increased rate of infections compared to placebo. In addition, DHODH inhibitors such as IMU-838 are known to possess a direct antiviral effect. IMU-838 was successfully tested in two phase 1 clinical trials in 2017 and is currently being tested in phase 2 trials in patients with relapsing-remitting multiple sclerosis and ulcerative colitis. Furthermore, Immunic’s collaboration partner, Mayo Clinic, has started an investigator-sponsored proof-of-concept clinical trial testing IMU-838 activity in patients with primary sclerosing cholangitis. Immunic also intends to initiate an additional phase 2 trial in patients with Crohn’s disease.

Vidofludimus calcium (IMU-838) 

Celiac disease

IMU-856, which Immunic believes to be novel, is an orally available, &nbsp;small molecule modulator that targets a protein which serves as a &nbsp;transcriptional regulator of intestinal barrier function and &nbsp;regeneration of bowel epithelium. Immunic has not yet disclosed the &nbsp;molecular target for IMU-856.

IMU-856

COVID-19

Infectious disease

IMU-838 is a small molecule investigational drug (vidofludimus calcium) under development as an oral tablet&nbsp;formulation for the treatment of relapsing-remitting multiple sclerosis, or RRMS, inflammatory bowel disease, or IBD, and other chronic inflammatory and autoimmune diseases.&nbsp;The company is also investigating IMU-838 as a potential treatment option for coronavirus disease 2019, or&nbsp;COVID-19.
By inhibiting dihydroorotate dehydrogenase (DHODH), a key enzyme of pyrimidine de novo biosynthesis, metabolically activated T and B immune cells experience metabolic stress, and the release of Th1 and Th17 key cytokines including IL-17A, IL-17F and IFNg is inhibited, thereby reducing inflammation. In preclinical studies of vidofludimus, the active moiety and free acid form of IMU-838, apoptosis (or programmed cell death) was induced in activated T cells, which Immunic believes may also play a crucial role in the activity of the drug by further dampening the inflammatory response (<a href="https://www.immunic-therapeutics.com/imu838/">Learn more</a>).&nbsp;

Bowel disorder

Inflammatory bowel disease

Ulcerative colitis

IMU-838 is an orally available, next-generation selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme dihydroorotate dehydrogenase (DHODH). IMU-838 acts on activated T and B cells while leaving other immune cells largely unaffected and allows the immune system to stay functioning, e.g. in fighting infections. In previous trials, IMU-838 did not show an increased rate of infections compared to placebo. In addition, DHODH inhibitors such as IMU-838 are known to possess a direct antiviral effect. IMU-838 was successfully tested in two phase 1 clinical trials in 2017 and is currently being tested in phase 2 trials in patients with relapsing-remitting multiple sclerosis and ulcerative colitis. Furthermore, Immunic’s collaboration partner, Mayo Clinic, has started an investigator-sponsored proof-of-concept clinical trial testing IMU-838 activity in patients with primary sclerosing cholangitis. Immunic also intends to initiate an additional phase 2 trial in patients with Crohn’s disease.

Bile duct disease

Liver disease

Primary sclerosing cholangitis

IMU-838 is an orally available, next-generation selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme dihydroorotate dehydrogenase (DHODH). IMU-838 acts on activated T and B cells while leaving other immune cells largely unaffected and allows the immune system to stay functioning, e.g. in fighting infections. In previous trials, IMU-838 did not show an increased rate of infections compared to placebo. In addition, DHODH inhibitors such as IMU-838 are known to possess a direct antiviral effect. IMU-838 was successfully tested in two phase 1 clinical trials in 2017 and is currently being tested in phase 2 trials in patients with relapsing-remitting multiple sclerosis and ulcerative colitis. Immunic intends to initiate an additional phase 2 trial in patients with Crohn’s disease later in 2019. Furthermore, Immunic’s collaboration partner, Mayo Clinic, has started an investigator-sponsored proof-of-concept clinical trial testing IMU-838 activity in patients with primary sclerosing cholangitis.

Psoriasis

IMU-935 is a highly potent and selective inverse agonist of RORγt (retinoic acid receptor-related orphan nuclear receptor gamma truncated) with additional activity on DHODH (dihydroorotate dehydrogenase). The nuclear receptor RORγt is&nbsp;believed to be the main driver for the differentiation of Th17 cells and the expression of cytokines involved in various inflammatory and autoimmune diseases. This target is believed to be an attractive alternative to approved antibodies for targets such as IL-23, IL-17 receptor and IL-17, itself. IMU-935 shows strong cytokine inhibition targeting both Th17 and Th1 responses in preclinical testing, as well as indications of activity in animal models for psoriasis and inflammatory bowel disease. Preclinical experiments indicate that, while leading to a potent inhibition of Th17 differentiation and cytokine secretion, IMU-935 did not affect thymocyte maturation. IMU-935 is an investigational drug product that has not been approved in any jurisdiction.

Immunic

Company Details