Immunic reveals MS drug trial success

Описание: Immunic Inc (NASDAQ:IMUX) CEO Dr Daniel Vitt talked with Proactive's Stephen Gunnion about new positive data from the company’s phase 2 EMPhASIS trial of vidofludimus calcium in relapsing-remitting multiple sclerosis (RRMS). The discussion also referenced the companion CALLIPER study in progressive MS, reinforcing the drug’s potential neuroprotective benefits.

Vitt said the low rate of confirmed disability worsening seen in EMPhASIS patients highlights a meaningful advancement. “It has the potential to really get beyond what current drugs are offering to patients,” he stated. The long-term follow-up revealed that 92.7% of participants remained free of 24-week confirmed disability progression after 144 weeks.

The safety profile was also discussed, with Dr Vitt highlighting that 182 of the original 254 patients from the open-label extension remain on active treatment, underscoring strong tolerability.

He reviewed the EMPhASIS trial’s structure—three dosing arms tested against placebo with significant reductions in cumulative unique active and gadolinium-enhancing lesions seen in the 30mg and 45mg groups during the main treatment period. The company observed a more than 50% reduction in disability progression, even in early datasets.

Vitt also noted the importance of confirmed disability worsening (CDW) for MS patients, linking it to long-term quality of life and independence. He emphasized that stopping or slowing CDW remains a key unmet need.

Looking forward, Immunic has initiated two phase 3 ENSURE studies in relapsing MS, aiming for data readouts by the end of next year. These will support a potential regulatory filing. The CALLIPER study in progressive MS showed a 24% reduction in CDW overall and 32% in the primary progressive MS subgroup, reinforcing the neuroprotective potential of vidofludimus calcium.

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