Analyzing Phase 2 CALLIPER Trial of IMU-838 for Progressive MS: Robert J. Fox, MD


The staff neurologist at the Mellen Center for Multiple Sclerosis at Cleveland Clinic talked about findings from an interim analysis of the phase 2 CALLIPER trial assessing vidofludimus calcium in progressive multiple sclerosis. [WATCH TIME: 4 minutes]

WATCH TIME: 4 minutes

"In this interim analysis, neurofilament levels showed a more than 40% reduction in patients with active inflammation, marking a significant step forward in understanding the potential impact of vidofludimus calcium on progressive MS."

IMU-838 (Immunic), a known inhibitor of the enzyme dihydroorotate dehydrogenase (DHODH), which is a key enzyme in the metabolism of overactive immune cells and virus-infected cells, has shown promising results in previous studies for treating patients with relapsing forms of multiple sclerosis (MS). The agent has demonstrated a mechanistic ability to selectively act on hyperactive T and B cells while leaving other immune cells largely unaffected and thus enabling normal immune system function to occur.

In an interim analysis of the phase 2 CALLIPER (NCT05054140) assessing the efficacy and safety of IMU-838, or vidofludimus calcium, in patients with progressive MS, results showed reductions in neurofilament light chain (Nfl) after 24 weeks of treatment. Notably, these reductions were consistent across progressive MS subtypes.1 In the study, investigators randomized 467 patients with primary progressive MS (35.2%), non-active secondary primary MS (59.5%) and active secondary primary MS (7.9%) 1:1 to IMU-838 or placebo for up to 120 weeks.

These findings were presented at the 2024 Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, February 29 to March 2, by lead author Robert J. Fox, MD, staff neurologist at the Mellen Center for Multiple Sclerosis at Cleveland Clinic. Fox recently sat down with NeurologyLive® at the meeting to discuss how IMU-838 differs from another DHODH inhibitors. He also talked about the key pathways targeted by IMU-838 in addressing inflammation and progression in MS, as well as how the observed reduction in neurofilament levels correlates with improved outcomes in the disease.

Click here for more coverage of ACTRIMS 2024.

1. Fox RJ, Wolf C, Ondrus M, et al. Impact of Vidofludimus Calcium on Serum Neurofilament in Progressive MS: Data From the CALLIPER Interim Analysis. Presented at ACTRIMS Forum 2024; February 29 to March 2; West Palm Beach, Florida. P044.
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