NEW YORK, June 15, 2022 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, today announced that data from its phase 2 EMPhASIS trial of lead asset, vidofludimus calcium (IMU-838), in patients with relapsing-remitting multiple sclerosis (RRMS), has been published in the peer reviewed journal, Annals of Clinical and Translational Neurology.
The paper, authored by coordinating investigator, Robert J. Fox, M.D., Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurologic Institute, Cleveland Clinic, Cleveland, Ohio, is entitled, "Safety and efficacy of vidofludimus calcium, a selective dihydroorotate dehydrogenase inhibitor, in relapsing-remitting multiple sclerosis (EMPhASIS): a double-blind, randomized, placebo-controlled phase 2 trial." It can be accessed through the following link: https://onlinelibrary.wiley.com/doi/10.1002/acn3.51574.
Vidofludimus calcium is a novel and second generation selective dihydroorotate dehydrogenase (DHODH) inhibitor without off-target effects on kinases seen with drugs of the same class, which may lead to a better safety and tolerability profile. The inhibition of DHODH has been shown to suppress magnetic resonance imaging (MRI) brain lesions and disease activity in multiple sclerosis. The paper assessed the safety and activity on MRI-based endpoints as well as clinical and biomarker assessments of vidofludimus calcium in patients with RRMS.
"The results from this phase 2 trial of vidofludimus calcium in patients with RRMS are encouraging, as the trial met its primary and key secondary endpoints for suppressing the number of combined unique active magnetic resonance imaging lesions," stated Dr. Fox. "Importantly, vidofludimus calcium was found to be safe and well-tolerated as compared to placebo, with no increase in the rate of infections, effects on liver or blood cell laboratory parameters and with a very low treatment discontinuation rate." Dr. Fox receives consulting fees for serving as an advisor to Immunic.
"The publication of the EMPhASIS trial results in a peer-reviewed journal is a testament to the importance of our phase 2 findings for vidofludimus calcium in patients with RRMS," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "Based on these strong data, we have enrolled patients in our phase 2 CALLIPER trial in progressive multiple sclerosis patients to further explore vidofludimus calcium's neuroprotective potential, as exemplified by a slowing of brain atrophy and delay in disability worsening, which are often caused by axonal and neural damage. Equally exciting, we have also been enrolling patients in our phase 3 ENSURE program of vidofludimus calcium as a treatment for relapsing multiple sclerosis (RMS). We remain highly enthusiastic about the potential for this novel therapeutic to become a best-in-class DHODH inhibitor in RMS."
The full unblinded data from the double-blind, placebo-controlled, phase 2 EMPhASIS trial (Cohort 1 with 30 and 45 mg of vidofludimus calcium or placebo once-daily) were reported by Immunic in September of 2020 and are summarized in more detail in this peer-reviewed journal. The trial achieved all primary and key secondary endpoints. In particular, the study met its primary endpoint, demonstrating a statistically significant reduction in the cumulative number of combined unique active (CUA) MRI lesions up to week 24 in patients receiving 45 mg of vidofludimus calcium once-daily, by 62% (p=0.0002), as compared to placebo. The study also met its key secondary endpoint, showing a statistically significant reduction in the cumulative number of CUA MRI lesions for the 30 mg once-daily dose, by 70% (p