Trial: Vidofludimus calcium shows benefits for 9 of 10 RRMS patients
Most participants remain free from disability-worsening events after 3 years
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) portion, where patients have been on treatment with vidofludimus calcium for up to 5.5 years. No new safety issues have been identified over this period, according to the company.
“It is meaningful to see that patients treated with vidofludimus calcium during the OLE period of our phase 2 EMPhASIS trial in RRMS experienced a low rate of confirmed disability worsening (CDW) events,” Andreas Muehler, MD, chief medical officer of Immunic, said in a company press release. “This data, representing approximately 952 treatment years, further underlines our belief that vidofludimus calcium holds great potential to effectively manage the disease, help preserve neurological function, allow patients to maintain independence and improve long-term quality of life.”
Vidofludimus calcium designed to reduce inflammation, protect nerve cells
Vidofludimus calcium is designed to reduce inflammation by inhibiting an immune cell protein called DHODH, while also protecting nerve cells from damage by activating a nerve protein called Nurr1.
The therapy’s unique mechanism of action “could represent a unique new oral therapy targeted to the complex [disease biology] of MS,” said Daniel Vitt, PhD, CEO of Immunic.
The EMPhASIS study enrolled 268 adults with RRMS to test three doses of vidofludimus calcium (10 mg, 30 mg, and 45 mg) against a placebo over about six months. Results showed the higher doses reduced the total number of active lesions, namely new or enlarging lesions and lesions with active inflammation, by more than 70% compared with the placebo.
Participants given any dose of vidofludimus calcium also experienced fewer relapses compared with a placebo, and had about two times fewer disability progression events after six months (1.6% vs. 3.7%).
After completing the main trial, patients had the option to continue into an open-label extension where all participants are being treated with vidofludimus calcium for up to 9.5 years. Patients were initially given either 30 mg or 45 mg, but all then received the 30 mg dose.
More than 90% of patients free from confirmed disability worsening events
The new data cover 182 patients in the open-label extension who were evaluated for 144 weeks, or nearly three years. Data showed 92.3% of the patients did not experience any 12-week CDW event, defined as an increase in Expanded Disability Status Scale (EDSS) scores that is confirmed in a follow-up visit at least 12 weeks later. Similarly, 92.7% of patients remained free of 24-week CDW events over the 144 weeks.
“The ability to maintain remarkably low rates of disability progression is among the most important unmet needs in relapsing MS despite the availability of multiple anti-inflammatory drugs approved for the treatment of MS relapses,” Vitt said. “By delaying disease progression, MS patients maintain greater independence, face a lower burden in managing their symptoms, and experience more favorable long-term outcomes.”
Of the 29 12-week CDW events that were observed, 44.8% occurred due to relapse-associated worsening — that is, patients experienced a disease relapse where symptoms suddenly worsened. Some symptoms continued to linger even after the flare was over, leading to worse disability. Only 13.8% of CDW events were associated with progression independent of relapse activity.
Previously announced data across our multiple sclerosis (MS) program, including from the EMPhASIS trial, as well as our recent top-line data from the phase 2 CALLIPER trial in progressive multiple sclerosis, has further highlighted vidofludimus calcium’s potential to slow disease progression in MS.
Vidofludimus calcium is now being evaluated as a potential treatment for relapsing forms of MS in a pair of Phase 3 clinical trials called ENSURE-1 (NCT05134441) and ENSURE-2 (NCT05201638). These studies have collectively enrolled more than 2,200 patients and aim to prove that a 30 mg dose of vidofludimus calcium can delay the time to a first relapse compared with a placebo.
In addition to these trials in relapsing MS, a separate Phase 2 trial called CALLIPER (NCT05054140) also tested vidofludimus calcium in more than 400 people with progressive forms of MS. Top-line data indicated the therapy reduced the risk of 24-week CDW, even in patients without signs of active inflammation.
“Previously announced data across our multiple sclerosis (MS) program, including from the EMPhASIS trial, as well as our recent top-line data from the phase 2 CALLIPER trial in progressive multiple sclerosis, has further highlighted vidofludimus calcium’s potential to slow disease progression in MS,” Vitt said.
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