Immunic is currently pursuing three development programs. These include the 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 RORγt, an immune cell-specific isoform of retinoic acid receptor-related orphan nuclear receptor gamma, or RORγ, and the IMU-856 program, which involves the development of a drug targeting the restoration of intestinal barrier function. These product candidates are being developed to address diseases such as relapsing-remitting multiple sclerosis, ulcerative colitis, Crohn’s disease, and psoriasis. 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, as well as metastatic castration-resistant prostate cancer.
An additional investigator-sponsored phase 2 clinical trial of IMU-838 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.
Indication: 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 affects approximately one million people in the United States, and more than 2.8 million people worldwide. 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.
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.
Indication: Ulcerative Colitis
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.
Indication: Crohn’s Disease
Crohn’s disease, or CD, is an idiopathic chronic inflammatory disease of unknown etiology with genetic, immunologic and environmental influences. Like UC, it is one of the major diseases that are generally characterized as IBD. Both UC and CD are caused by chronic inflammation in the gastrointestinal, or GI, tract, but CD can involve the entire GI tract, from the mouth to the anus (but it most commonly involves both the large and small intestines), whereas UC is restricted to the colon and rectum. Distinguishing CD from UC can be challenging when inflammation is confined to the colon. CD typically involves all layers of the bowel wall, thereby causing complications such as abscesses, strictures and fistulas that regularly require surgical intervention.
Hallmark clinical symptoms of CD are chronic diarrhea and abdominal pain. However, the diagnosing physician needs to evaluate laboratory tests, endoscopy results, pathology findings and radiographic tests to arrive at a clinical diagnosis of CD. In general, it is the presence of chronic intestinal inflammation that leads to a diagnosis of CD.
CD is most commonly diagnosed in late adolescence or early adulthood, but it can manifest at any age. According to recent data and literature reviews on the incidence of CD, there are more than 600,000 patients affected by CD in the United States, as well as 1.1 million in Europe and more than 125,000 in Canada. CD is slightly more prevalent in women than in men.
Indication: Primary Sclerosing Cholangitis
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. 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. 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.
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. 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.
Indication: Castration-Resistant 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.
Prostate cancer initiation and disease progression are driven by androgen receptor, or AR, signaling. Clinical manifestations of prostate cancer are frequently absent at the time of diagnosis. More advanced stage of the disease may present with urinary retention and back pain, as axis skeleton is the most common site of metastatic disease. Clinical signs associated with prostate cancer include an elevated prostate-specific antigen, or PSA, on laboratory testing and an abnormal prostate finding on digital rectal examination.
Androgen deprivation therapy, or ADT, is a usual first-line option for men with advanced prostate cancer, but the vast majority eventually progress while receiving ADT. This disease state is also referred to as castration-resistant prostate cancer, or CRPC.
Indication: Guillain Barré Syndrome
Historically, Guillain Barré syndrome, or GBS, was considered a single disease entity. It is now known to be a heterogeneous syndrome with several variant forms. Acute inflammatory demyelinating polyradiculopathy, or AIDP, is the most common form in North America, Europe and most of the developed world, where it accounts for approx. 90% of cases. GBS is thought to result from an immune response to a preceding infection that cross-reacts with peripheral nerve components. The exact mechanisms are unknown. However, cellular and humoral immune responses are of relevance in the pathogenesis of GBS.
The clinical manifestation of GBS is characterized by an acute or subacute onset of a progressive, symmetric weakness in limbs or cranial nerve-innervated muscles, accompanied by absent or depressed deep tendon reflexes, and a characteristic profile in the cerebrospinal fluid and electrodiagnostic studies. Patients usually present a few days to a week after onset of symptoms. The weakness can vary from mild difficulty with walking to nearly complete paralysis of all extremity, facial, respiratory, and bulbar muscles.
GBS occurs worldwide with an overall incidence of 0.16 to 3.0 per 100,000 person-years. Thus, it is considered a rare disease. The incidence increases by approx. 20% with every 10-year increase in age beyond the first decade of life. In addition, the incidence is slightly greater in males than in females.
 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.
 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.
 Singh S, Talwalkar JA. Primary sclerosing cholangitis: diagnosis, prognosis, and management. Clin Gastroenterol Hepatol. 2013;11(8):898–907.
 Di Meglio P, Villanova F, Nestle FO. Psoriasis. Cold Spring Harb Perspect Med. 2014;4(8):a015354.
 Sung H et al, CA Cancer J Clin 2021 May;71(3):209-249.
 Hughes RAC, Cornblath DR. Guillain-Barré syndrome. Lancet. 2005;366(9497):1653–66.
 McGrogan A, Madle GC, Seaman HE, de Vries CS. The epidemiology of Guillain-Barré syndrome worldwide. A systematic literature review. Neuroepidemiology. 2009;32(2):150–63.
 Sejvar JJ, Baughman AL, Wise M, Morgan OW. Population incidence of guillain-Barré syndrome: A systematic review and meta-analysis. Neuroepidemiology. 2011;36(2):123–33.