Next Generation DHODH Inhibitor Helps Delay Disability in Those with Relapsing-Remitting MS
New clinical trial data suggest that vidofludimus calcium therapy (VidoCa; Immunic, New York, NY) for relapsing-remitting multiple sclerosis (RRMS) may help delay disability progression when compared with those taking a placebo. The findings, which were presented at the Americas Committee for Treatment & Research in Multiple Sclerosis (ACTRIMS) Forum 2023, provide long-term data about vidofludimus calcium, a highly selective oral 2nd generation DHODH inhibitor.
The phase 2 EMPhASIS trial (NCT03846219) was a randomized, placebo-controlled study in individuals diagnosed with RRMS, assessing efficacy and safety of 10 mg, 30 mg, and 45 mg of vidofludimus calcium compared with placebo for a period of 24 weeks. When study participants completed the double-blind treatment period, they were invited to enter the long-term, open-label extension (OLE) period with further monitoring of safety, tolerability, and efficacy parameters. All participants in the OLE period received either 30 mg or 45 mg of vidofludimus calcium.
For the initial 24-week double-blind treatment period, 12-week Confirmed Disability Worsening (12wCDW) and 24-week Confirmed Disability Worsening (24wCDW) events occurred in 1.6% of individuals in the combined treatments arms compared with 3.7% in the placebo group. In the OLE period, the percentage of patients free from 12wCDW was 97.2% after 48 weeks and 94.2% after 96 weeks of treatment. Three percent of participants in the OLE period of the trial experienced one or more relapses within the first year and 6.2% within the first 2 years.
According to comments provided by Daniel Vitt, PhD, CEO and President of Immunic, "We eagerly await reporting data from our ongoing phase 3 ENSURE program in relapsing MS as well as our ongoing phase 2 CALLIPER trial in progressive MS. In the second half of this year, we already expect to provide selected biomarker data from an interim analysis of the CALLIPER trial to guide study progress.”