Pipeline

Our Pipeline

Immunic is currently pursuing three development programs

Vidofludimus Calcium (IMU-838), IMU-935, IMU-856

Immunic is currently pursuing three development programs. These include the vidofludimus calcium (IMU-838) program, which is focused on the development of oral formulations of small molecule inhibitors of the enzyme dihydroorotate dehydrogenase, or DHODH; the IMU-935 program, which is focused on an inverse agonist of retinoic acid receptor-related orphan nuclear receptor gamma truncated, or RORγt, an immune cell-specific isoform of RORγ; and the IMU-856 program, which involves the development of a drug targeting the restoration of intestinal barrier function and regeneration of bowel epithelium.

These product candidates are being developed to address diseases such as multiple sclerosis, inflammatory bowel disease, psoriasis, and celiac disease. In addition to these large markets, these products are also being developed to address certain rare diseases with high unmet medical needs, such as primary sclerosing cholangitis and Guillain-Barré syndrome.

Target: DHODH

Indication: Relapsing Multiple Sclerosis

Preclinical
Phase 1
Phase 2
Phase 3

Indication: Progressive Multiple Sclerosis

Preclinical
Phase 1
Phase 2

Indication: Primary Sclerosing Cholangitis

Preclinical
Phase 1
Phase 2

Program: IMU-935

Target: IL-17/RORyt

Indication: Psoriasis

Preclinical
Phase 1

Indication: Castration-Resistant Prostate Cancer

Preclinical
Phase 1

Program: IMU-856

Target: Intestinal Barrier Function

Indication: Celiac Disease

Preclinical
Phase 1
Completed or ongoing

In preparation or planned

An additional investigator-sponsored phase 2 clinical trial of vidofludimus calcium in combination with oseltamivir in patients with moderate-to-severe COVID-19 is ongoing in collaboration with the University Hospitals Coventry and Warwickshire NHS Trust, UK.

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Multiple Sclerosis
Patients Worldwide
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Psoriasis
Patients Worldwide

Indications

More about the
indications targeted

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.[1] The disease mainly affects young adults of prime working age, although MS can occur at any age. MS is at least two to three times more common in women than in men.[2]

Relapsing-remitting MS, or RRMS, is the most common form of the disease. Approximately 85% of patients with MS are expected to develop RRMS, with some of these patients later developing more progressive forms of the disease. RRMS 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.

Primary sclerosing cholangitis, or PSC, is a rare liver disease in which the bile ducts in the liver become inflamed, narrow and prevent bile from flowing properly. PSC has a prevalence of approximately 4.15 per 100,000 in the United States[3]. The exact cause and disease mechanism of PSC are still unknown, but an autoimmune mechanism may play a role. There is an association with IBD, most often with UC and less commonly with CD[4]. Progressive biliary and hepatic damage results in portal hypertension and hepatic failure in a significant majority of patients over a 10-15 year period from initial diagnosis[4].

Psoriasis is a chronic inflammatory disease of the skin with unknown etiology that leads to hyperproliferation of keratinocytes and endothelial cells. Most mechanistic data support the hypothesis that psoriasis is an autoimmune disease driven by activated T-lymphocytes which then release cytokines, chemokines and pro-inflammatory molecules into the dermis and epidermis. Psoriasis is characterized clinically by development of red, scaly, itchy, symmetrical, dry plaques typically located on skin overlying the elbows, knees, lumbar area and scalp. Plaques vary from a few millimeters in diameter to several centimeters and can be localized to a specific area or extend over most of the body surface.

Psoriasis is one of the most common chronic inflammatory skin diseases[5]. The disease prevalence varies between geographic regions. Studies of psoriasis suggest an overall prevalence of 2% to 3% of the world’s population, with a higher prevalence in U.S. and Canadian populations (4.6% and 4.7%, respectively). Psoriasis is considered equally prevalent between genders and can occur at any age. However, there seems to be a bimodal distribution of the age of disease onset, with a first peak between 15 and 30 years, and a second peak between 50 and 60 years of age.

Castration-resistant prostate cancer, or CRPC, is a form of advanced prostate cancer. With an estimated almost 1.4 million new cases and 375,000 deaths worldwide, prostate cancer is the second most frequent cancer and the fifth leading cause of cancer death among men in 2020.[6]

Because early stages of prostate cancer rely on testosterone to grow, approaches to lower testosterone can be employed therapeutically. With CRPC, the cancer no longer completely responds to treatments that lower testosterone, significantly limiting available treatment options in these patients. Common sites of metastasis are lymph nodes, bones, bladder, rectum, lung, or liver. Although metastatic CRPC may be asymptomatic, typical signs/symptoms include problems urinating, pain while passing urine or blood in the urine, tiredness, weakness, weight loss, shortness of breath, or bone pain. The main goal in treating metastatic CRPC is to control symptoms and slow progression.

Celiac disease is a chronic autoimmune condition of the small intestine in which ingestion of dietary gluten triggers an inflammatory response in genetically susceptible individuals. Over time, the immune reaction damages the lining of the small intestine and prevents it from absorbing some nutrients (malabsorption). This often causes diarrhea, fatigue, weight loss, bloating and anemia, and can lead to other serious complications. In children, nutrient malabsorption can affect growth and development, in addition to causing the symptoms seen in adults. There is currently no known cure 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[7] is estimated to affect 1 in 100 people, worldwide. In the U.S., alone, it is estimated that 2.5 million people are undiagnosed and are, therefore, at risk for long-term health complications.

  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. Toy E, Balasubramanian S, Selmi C, Li C-S, Bowlus CL. The prevalence, incidence and natural history of primary sclerosing cholangitis in an ethnically diverse population. BMC Gastroenterol. 2011;11:83.
  4. Singh S, Talwalkar JA. Primary sclerosing cholangitis: diagnosis, prognosis, and management. Clin Gastroenterol Hepatol. 2013;11(8):898–907.
  5. Di Meglio P, Villanova F, Nestle FO. Psoriasis. Cold Spring Harb Perspect Med. 2014;4(8):a015354.
  6. Sung H et al, Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin 2021 May;71(3):209-249.
  7. Celiac Disease Foundation. What is Celiac Disease? 2022. Available from:https://celiac.org/about-celiac-disease/what-is-celiac-disease/