- Unblinded Subgroup Analyses Show Consistent Effect for MRI Lesion Suppression Across Different Populations -
- Time Course of MRI Lesion Suppression Shows Reduction of Lesions Already Present at First Post-Baseline Scan at Week 6, Validating Rapid Attainment of Stable Therapeutic Drug Levels of IMU-838 -
- A Robust Decrease in Serum Neurofilament Light Chain, A Biomarker for Axonal Damage, Was Observed in Both Treatment Arms of IMU-838 But Not in the Placebo Arm -
- Poster, Including Audio Track, With Summary of Full Data Set, to be Presented Online at the MSVirtual2020 / 8th Joint ACTRIMS-ECTRIMS Meeting by Robert J. Fox, M.D. -
- Conference Call and Webcast to Review the Full Unblinded EMPhASIS Data to be Held September 14, 2020 at 8:00 am ET -
NEW YORK, Sept. 11, 2020 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, today announced that the full unblinded clinical data set from the company's phase 2 EMPhASIS trial of lead asset, IMU-838, a selective oral DHODH inhibitor, in patients with relapsing-remitting multiple sclerosis (RRMS) is now available and expands on and confirms the company's previously announced positive top-line results. A summary will be presented at the MSVirtual2020 / 8th Joint ACTRIMS-ECTRIMS Meeting, taking place September 11-13, 2020, online, by Robert J. Fox, M.D., Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurologic Institute, Cleveland Clinic, Cleveland, Ohio.
Abstract Title: Top-line Results of EMPhASIS, a Phase 2 Clinical Trial of Vidofludimus Calcium (IMU-838) in Relapsing-Remitting Multiple SclerosisAbstract Number: 1409Poster Number: P0241
The poster presentation, including Dr. Fox's audio track, will be published today at 8:00 am ET in the MSVirtual2020 E-Poster Hall. Dr. Fox's poster presentation as well as the full unblinded EMPhASIS data will be filed on Form 8-K today, before the opening of the U.S. financial markets, and will be accessible on the "Events and Presentations" section of Immunic's website at: ir.imux.com/events-and-presentations.
"The results from the phase 2 study of IMU-838 in patients with RRMS are encouraging, as the data show that the trial has met its primary and key secondary endpoints with high statistical significance," stated Dr. Fox. "Importantly, IMU-838 appears to be safe and well-tolerated with robust suppression of combined unique active MRI lesions, which compares favorably to other first-line and oral medications in RRMS." Dr. Fox receives compensation as a chair of the steering committee for the EMPhASIS trial.
As previously announced, the phase 2 EMPhASIS 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) magnetic resonance imaging (MRI) lesions up to week 24 in patients receiving 45mg of IMU-838 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 30mg once-daily dose, by 70% (p