2 Years of Vidofludimus Calcium Thwarts Disability Progression: Data

The EMPhASIS trial has been running for almost 3.5 years

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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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 3.5 years.

“Only a few patients on continuous open-label treatment with vidofludimus calcium developed confirmed disability worsening events over a 2-year time frame, and those rates observed with vidofludimus calcium are on the lower end of those observed in historical trials with currently approved MS medications,” Daniel Vitt, PhD, president and CEO of Immunic, said in a company press release.

Vidofludimus calcium is a small molecule that interferes with the normal metabolism of T-cells and B-cells, immune cells that drive inflammation in multiple sclerosis (MS). It works by inhibiting dihydroorotate dehydrogenase (DHODH), an enzyme essential for these cells’ proliferation, reducing pro-inflammatory molecule production and eventually leading to cell death.

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1st RRMS Patient Enrolled in ENSURE-2 Trial of Oral IMU-838

The Phase 2 EMPhASIS trial (NCT03846219) enrolled about 270 adults with RRMS who were randomly assigned to take vidofludimus calcium at one of three daily doses – 10, 30, or 45 mg – or a placebo for six months.

The study’s main goal was to assess the effect of treatment on total active lesions, including new lesions, enlarging lesions, and lesions that showed evidence of ongoing inflammation. Top-line results announced in 2020 showed that goal was met, with the 45 mg dose reducing lesion counts by 62%, and the 30 mg dose by 70%.

Rates of confirmed disability worsening were overall low in the relatively short study, but tended to be lower in patients treated with vidofludimus calcium compared to placebo (1.6% vs. 3.7%).

“Data from our phase 2 EMPhASIS trial of vidofludimus calcium in RRMS patients demonstrate an encouraging signal in preventing 12-week and 24-week confirmed disability worsening events as compared to placebo during the double-blind treatment phase,” Vitt said.

After the placebo-controlled part of the the EMPhASIS trial, participants could continue into an open-label extension, where all are being treated with vidofludimus calcium and followed for up to nearly a decade.

The new interim analysis was performed on data collected as of October 2022 on 209 patients in the extension. Some have been on continuous treatment with vidofludimus calcium for nearly four years, according to Immunic.

After 48 weeks (nearly a year) in the extension, a majority (97.6%) have not had confirmed disability worsening. The rate was only slightly lower at 94.5% after 96 weeks (about two years). Meanwhile, relapse activity has been low, according to Immunic. The company did not provide specific relapse rates in this analysis.

Immunic is currently sponsoring a pair of identically designed Phase 3 trials, ENSURE-1 (NCT05134441) and ENSURE-2 (NCT05201638), to further assess the safety and effectiveness of vidofludimus calcium with relapsing types of MS.

The company is also sponsoring a Phase 2 trial called CALLIPER (NCT05054140) to test it in adults with progressive forms, namely primary progressive MS and nonactive secondary progressive MS.

All three trials are still enrolling participants at sites globally and top-line data is expected in 2024.

“We look forward to receiving further, confirmatory data from our phase 3 ENSURE program in relapsing MS as well as our phase 2 CALLIPER trial in progressive MS,” Vitt said. “Our next MS-related data inflection point is an interim analysis for CALLIPER at the end of 2023 which will provide selected biomarker and functional data to guide study progress.”

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