Stage (next event)
Catalyst Info & Data Links
TITLE: IMU-838 in Primary Sclerosing Cholangitis
ClinicalTrials.gov (NCT03341962): Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)
WHAT IS THE NEXT CATALYST EVENT?
Phase 2 Data
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
Mechanism of Action
MECHANISM OF ACTION
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.
Primary Sclerosing Cholangitis (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
Updated by HC
Prior Data (click to view full image)
Trial Design / Revenue (click to view full image)
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