More than 90% of relapsing-remitting multiple sclerosis (RRMS) patients who received Immunic Therapeutics‘ experimental oral therapy vidofludimus calcium have not experienced confirmed disability worsening after nearly three years. That’s according to new data from the EMPhASIS Phase 2 clinical trial (NCT03846219) and its open-label extension (OLE)…
vidofludimus calcium
Enrollment is now complete in the twin Phase 3 clinical trials testing Immunic Therapeutics‘ oral small molecule vidofludimus calcium in adults with relapsing forms of multiple sclerosis (MS). ENSURE-1 (NCT05134441) has enrolled 1,121 patients and ENSURE-2 (NCT05201638) has enrolled 1,100 patients at more than 100…
Vidofludimus calcium, an experimental oral therapy from Immunic Therapeutics, reduced the risk of confirmed disability worsening and slowed brain shrinkage in people with progressive forms of multiple sclerosis (MS). That’s according to top-line data from CALLIPER (NCT05054140), a Phase 2 clinical trial testing a daily dose of…
Immunic Therapeutics says it remains “on track” in testing its multiple sclerosis treatment candidate vidofludimus calcium in twin Phase 3 clinical trials with people who have relapsing disease — and in the Phase 2 CALLIPER study involving those with progressive forms of MS. Indeed, in a new company…
An independent data monitoring committee has recommended that the twin ENSURE Phase 3 trials testing vidofludimus calcium in people with relapsing forms of multiple sclerosis (MS) continue as planned without adjustments. The opinion that the trials are worth continuing was based on a review of interim, unblinded trial…
A lower dose of the experimental oral therapy vidofludimus calcium (IMU-838) was not as effective as higher doses at reducing lesions in people with relapsing-remitting multiple sclerosis (RRMS), extended data from the therapy’s Phase 2 EMPhASIS trial show. “We found that doses of 30 mg and 45 mg,…
Treatment with Immunic Therapeutics‘ experimental oral therapy vidofludimus calcium (IMU-838) lowered the levels of a nerve damage marker in people with all subtypes of progressive multiple sclerosis (MS), including those without recent inflammatory activity. That’s according to an interim analysis of data from a Phase 2 study,…
The Patent and Trademark Office intends to grant a U.S. patent covering all dosing regimens of vidofludimus calcium — being developed as IMU-838 — for the treatment of multiple sclerosis (MS). That includes the doses being used in developer Immunic Therapeutics’ ongoing clinical program, according to a…
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)Â at a daily dose of about 10 to 45 mg. That range covers the two IMU-838 doses shown to be…
Vidofludimus calcium (IMU-838), an investigational oral therapy being developed by Immunic Therapeutics for all types of multiple sclerosis (MS), has demonstrated neuroprotective effects in people with progressive forms of the disease, interim clinical trial data show. The experimental therapy was associated with reductions in neurofilament light chain (NfL)…
A global Phase 2 clinical trial investigating the oral therapy vidofludimus calcium (IMU-838) in people with progressive forms of multiple sclerosis (MS) has reached full enrollment, the treatment’s developer, Immunic Therapeutics, reports. Called CALLIPER (NCT05054140), the trial is assessing whether the neuroprotective effects of vidofludimus calcium seen in…
Long-term treatment with vidofludimus calcium (IMU-838) has been tolerated well overall among people with relapsing-remitting MS (RRMS), new data from an extension study show. Findings were presented at the Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, in a poster titled “Assessment of Long-Term Safety…
Vidofludimus calcium (IMU-838), an investigational multiple sclerosis (MS) therapy with promising results in clinical trials, may exert neuroprotective effects by activating a protein called Nurr1, according to newly published preclinical data. The observed actions on Nurr1 are in addition to the therapy’s known role as an inhibitor of…
New data from a Phase 2 clinical trial testing vidofludimus calcium, Immunic Therapeutics’ novel oral treatment candidate for relapsing-remitting multiple sclerosis (RRMS), show promising safety and efficacy, according to the company’s chief medical officer. The therapy was found to safely reduce brain lesions and prevent disability progression in…
Most adults with relapsing-remitting multiple sclerosis (RRMS) who received Immunic Therapeutics‘ investigational therapy vidofludimus calcium have had no confirmed disability progression after two years of treatment. That’s according to new interim data from the open-label extension portion of the EMPhASIS trial, which has been running for nearly…
Vidofludimus Calcium Safely Reduced RRMS Brain Lesions Vidofludimus calcium, also called IMU-838, is an oral therapy designed to reduce the activity of B- and T-cells. These are immune cells believed to be responsible for the inflammation that results in MS damage. In this small study, active lesions — including…
Treatment with the experimental immune-modulating therapy vidofludimus calcium reduced disease activity on MRI scans in adults with relapsing-remitting multiple sclerosis (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…
Immunic Therapeutics 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…