Immunic enrolls first patient in IMU-838 trial for patients with PSC
Immunic announced enrollment of the first patient in an investigator-sponsored proof-of-concept clinical trial of IMU-838 for the treatment of patients with primary sclerosing cholangitis, or PSC. IMU-838 is an orally available selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme dihydroorotate dehydrogenase, or DHODH. PSC is a progressive disease of the liver with unknown cause and a prevalence of about 4.15 per 100,000 in the United States. Other than liver transplantation, there are currently no approved therapies that have been shown to improve survival in patients with PSC. The proof-of-concept study, for which Immunic is providing the study medication, is a single-arm, open-label, exploratory study planning to enroll a total of 30 patients with PSC, aged 18 to 75 years, who will receive 30mg IMU-838 once daily for a period of six months. The trial's primary endpoint is the change in serum alkaline phosphatase, or ALP, at six months compared to baseline. In previous trials, a biochemical endpoint such as change in serum ALP has been an accepted biomarker of disease progression in PSC patients.