Immunic Announces Completion of Enrollment for Both Phase 3 ENSURE Trials in Relapsing MS and Presents Additional Data Underlining Positive Outcome of Phase 2 CALLIPER Trial in Progressive MS

Core Insights - Immunic, Inc. has completed enrollment for both Phase 3 ENSURE trials of vidofludimus calcium in patients with relapsing multiple sclerosis (RMS), with top-line data expected by the end of 2026 [1][3] - Additional data from the Phase 2 CALLIPER trial in progressive multiple sclerosis (PMS) supports the positive results previously released, highlighting the neuroprotective potential of vidofludimus calcium [1][4] Group 1: ENSURE Trials - The ENSURE program consists of two identical multicenter, randomized, double-blind Phase 3 trials aimed at evaluating the efficacy, safety, and tolerability of vidofludimus calcium versus placebo in RMS patients [2] - A total of 1,121 patients were enrolled in ENSURE-1 and 1,100 patients in ENSURE-2, with the primary endpoint being the time to first relapse over 72 weeks [2] - Secondary endpoints include time to confirmed disability worsening, volume of new T2 lesions, and MRI-based endpoints [2] Group 2: CALLIPER Trial Data - In the Phase 2 CALLIPER trial, vidofludimus calcium demonstrated a 24% reduction in the hazard ratio for 24-week confirmed disability worsening (24wCDW) compared to placebo [5] - The drug showed a 33% reduction in 24wCDW in primary progressive multiple sclerosis (PPMS) patients, a 19% reduction in non-active secondary progressive multiple sclerosis (naSPMS), and a 34% reduction in active secondary progressive multiple sclerosis (aSPMS) [5] - For patients without evidence of gadolinium-enhancing lesions at baseline, vidofludimus calcium reduced 24wCDW by 34% compared to placebo [5][6] Group 3: Vidofludimus Calcium Overview - Vidofludimus calcium is an investigational oral small molecule drug targeting chronic inflammatory and autoimmune diseases, currently in late-stage clinical trials for multiple sclerosis [7] - The drug acts as a selective immune modulator, activating the neuroprotective transcription factor Nurr1 and inhibiting dihydroorotate dehydrogenase (DHODH) to provide neuroprotective, anti-inflammatory, and anti-viral effects [7] - The drug has been tested in approximately 2,700 individuals, showing an attractive pharmacokinetic, safety, and tolerability profile [7]