Immunic eyes Phase 3 after MS disability gains in Phase 2 CALLIPER trial

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1d ago 7:29

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Immunic Inc (NASDAQ:IMUX) CEO Dr Daniel Vitt talked with Proactive's Stephen Gunnion about the latest results from the company’s Phase 2 CALLIPER trial evaluating vidofludimus calcium in progressive multiple sclerosis (MS). The study aimed to assess the neuroprotective effects of the drug, specifically its impact on disability progression. Vitt said the top-line data showed a 20% overall reduction in disability progression, with an even greater 30% reduction in patients with primary progressive MS. He described this as a strong outcome, noting, “That’s amazing. I think nothing you usually expect.” He said the data reflects the compound’s unique mode of action. MRI analysis also revealed a 20% reduction in thalamic atrophy, a marker strongly associated with long-term disability. Importantly, no new safety concerns were observed, and the drug’s tolerability remained consistent across trials involving over 2,500 patients. Looking ahead, Immunic plans to engage with regulators, including the FDA and EMA, to seek breakthrough designation and prepare for a Phase 3 study. The company also highlighted ongoing discussions with potential pharmaceutical partners. For patients with limited options, Vitt noted, “Our drug specifically seems to work in those patients so far (who) could not benefit from current treatments.” Visit Proactive’s YouTube channel for more interviews. Don’t forget to like this video, subscribe, and turn on notifications for future updates. #Immunic #MultipleSclerosis #VidofludimusCalcium #MSResearch #BiotechNews #ClinicalTrials #CALLIPERStudy #Neuroprotection #FDA #Pharma

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