November 6, 2023 News by Margarida Maia, PhD US patent likely for vidofludimus calcium at relapsing MS trial dose Immunic Therapeutics has been notified of the intent to grant a U.S. patent covering the use vidofludimus calcium (IMU-838) in treating relapsing forms of multiple sclerosis (MS)Ā at a daily dose of about 10 to 45 mg. That range covers the two IMU-838 doses shown to be…
June 17, 2022 News by Marisa Wexler, MS Vidofludimus Calcium Safely Reduced RRMS Brain Lesions Treatment with the experimental immune-modulating therapy vidofludimus calcium reduced disease activity on MRI scans in adults with relapsing-remitting multiple sclerosisĀ (RRMS), data from the Phase 2 EMPhASIS clinical trial shows. Top-line results from EMPhASIS were reported by the therapy’s developer Immunic Therapeutics in 2020. Researchers at…
January 17, 2022 News by Marta Figueiredo, PhD 1st RRMS Patient Enrolled in ENSURE-2 Trial of Oral IMU-838 The ENSURE-2 Phase 3 clinical trial, evaluating Immunic Therapeuticsā experimental oral therapy IMU-838 (vidofludimus calcium) in adults with relapsing-remitting multiple sclerosis (RRMS), has enrolled its first patient. The milestone, announced in an email to Multiple Sclerosis News Today, follows the recruitment of the first RRMS patient in…
November 24, 2021 News by Marisa Wexler, MS 1st Patient Enrolled in ENSURE Trials of IMU-838 in RRMS Immunic TherapeuticsĀ has enrolled the first participant in its Phase 3 ENSURE clinical trial program, which is testing the company’s investigational treatment IMU-838 (vidofludimus calcium) in people with relapsing-remitting multiple sclerosis (RRMS). “Enrollment of the first patient in ENSURE … marks an important inflection point for Immunic as we…
October 1, 2021 News by Patricia Inacio, PhD CALLIPER Trial for Progressive MS Enrolls First Patient Immunic Therapeutics has enrolled the first patient in a Phase 2 clinical trial testing its oral therapy candidate IMU-838 for the treatment of progressive multiple sclerosis (MS). The trial, CALLIPER (NCT05054140), is expected to run in parallel to the companyās two identically-designed Phase 3 trials, dubbed…
July 12, 2021 Columns by Ed Tobias MS News That Caught My Eye Last Week: Sativex, IMU-838, Ibudilast, Supercomputer Sativex Eased MS Spasticity as an Add-on Therapy A reader in Belgium told me he has used Sativex for a couple months. He reported no dramatic improvements in his symptoms, but he said the spasticity in his right leg decreased, and he was in a much better mood to…
July 2, 2021 News by Marisa Wexler, MS Trials of IMU-838 in RRMS, Progressive MS Start Later This Year The U.S. Food and Drug Administration has cleared Immunic Therapeutics to initiate two clinical trials of its investigational medicationĀ IMU-838 (vidofludimus calcium) in people with relapsing-remitting multiple sclerosis (RRMS), as well as a separate trial for people with progressive types of MS. The RRMS clinical trial program, expected…
April 15, 2021 News by Steve Bryson, PhD Immunic Sets Optimal Dose of Oral IMU-838 for Phase 3 Trials in RRMS Interim data from a Phase 2 trial of Immunic Therapeutics’ investigational oral therapy IMU-838 (vidofludimus calcium) in relapsing-remitting multiple sclerosis (RRMS) patients has established a once-daily, 30 mg dose as the most appropriate for future Phase 3 trials. The…
November 16, 2020 Columns by Ed Tobias MS News That Caught My Eye Last Week: Possible MS Blood Test, IMU-838, aHSCT vs. Lemtrada Neurofilament Light Levels at First MS Event Can Predict Long-term Brain Atrophy Researchers are looking at a protein that’s released into the bodyās fluids when neurons become damaged. They hope it will help them predict ā as far as 10 years down the road from the first indication of…
November 11, 2020 News by Marta Figueiredo, PhD Additional Group of RRMS Patients Sought to Take Lower Dose of IMU-838 in Phase 2 Trial Immunic Therapeutics is seeking 60 more adults with relapsing-remitting multiple sclerosisĀ (RRMS) to test a lower dose of IMU-838, its leading oral experimental therapy, in its ongoing Phase 2 EMPhASIS trial. The decision was based on previous trial results showing that both doses tested (30 and 45 mg…
August 10, 2020 Columns by Ed Tobias MS News That Caught My Eye Last Week: Epstein-Barr and Smoking, Infections, Oral DMT Trial, Exercise and the Brain Smoking and Epstein-Barr Virus Combine to Raise MS Risk, Study Says A number of studies over several years have demonstrated a likely link between the Epstein-Barr virus and MS. Of course, there’s no question about the health risks of smoking. Put the two together, and it looks like double…
August 4, 2020 News by Marisa Wexler, MS Oral RRMS Therapy Safely Lowers Active Lesions in Phase 2 Trial, Data Show Immunic Therapeutics‘sĀ IMU-838, a selective immune system modulator, can safely lower the number of brain lesions in people with relapsing-remitting multiple sclerosisĀ (RRMS), top-line Phase 2 clinical trial data suggest. Findings show the trial met its primary goal with statistical significance ā a reduction inĀ active lesions (gadolinium…
October 15, 2019 News by Ana Pena PhD Immunic Therapeutics Fully Enrolls Phase 2 Trial of Oral IMU-838, Potential RRMS Treatment Immunic TherapeuticsĀ announced that a Phase 2 clinical trial of IMU-838, its experimental oral therapyĀ forĀ relapsing-remitting multiple sclerosis (RRMS), is fully enrolled ahead of schedule. The trial, called EMPhASIS, also exceeded its target number of participants: Immunic set an initial recruitment goal of 195 patients by mid-2020, and enrolled 210…
March 11, 2019 News by Alberto Molano, PhD Immunic Therapeutics Enrolls First Patient in Phase 2 Trial of IMU-838 for RRMS Immunic TherapeuticsĀ has enrolled the first patient in its Phase 2 clinical trial testing IMU-838, a potential oral therapy forĀ relapsing-remitting multiple sclerosis (RRMS). IMU-838 (vidofludimus calcium) is a next-generation selective modulator of the immune system. It works by inhibiting an enzyme called dihydroorotate dehydrogenase (DHODH), which plays a role…