Immunic announced the final patient was enrolled and randomized in the company's phase 2 EMPhASIS trial of IMU-838 for the treatment of relapsing-remitting multiple sclerosis (RRMS). Patient enrollment was completed ahead of the original trial schedule. Enrollment and randomization of the last patient was expected during the first half of 2020.
"Achievement of this milestone for our lead program, IMU-838, in RRMS, substantially ahead of prior expectations, reflects not only our team's strength in executing on the company's drug development strategy, but also the urgent need from patients for a safer oral treatment option," said Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "Backed by newly released preclinical data confirming the superior profile of IMU-838 versus the currently approved DHODH inhibitor, teriflunomide, we remain highly enthusiastic about the potential of IMU-838 to become an important new best-in-class oral therapeutic treatment alternative for patients with RRMS."
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The phase 2 EMPhASIS trial is an international, multicenter, double-blind, placebo-controlled, randomized, parallel-group study that enrolled 210 patients in 36 centers across four European countries, compared with a targeted enrollment of 195 patients. All enrolled patients were required to have shown disease activity based on clinical evidence of relapse and magnetic resonance imaging (MRI) criteria. The study's primary objective is to evaluate the dose response of 30 mg/day and 45 mg/day of IMU-838, once daily, for the treatment of RRMS based on MRI assessments. The primary endpoint is the cumulative number of combined unique active (CUA) MRI lesions, up to week 24. The study also includes an optional extended treatment period to evaluate long-term safety and tolerability. The data will be unblinded after all patients have completed the main treatment portion and the study database has been locked. Management continues to anticipate top-line data becoming available during the third quarter of 2020.
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.