Immunic is aiming for a big breakthrough in the treatment of multiple sclerosis

Core Insights - Immunic Inc is developing vidofludimus calcium, a first-in-class oral medication aimed at treating multiple sclerosis (MS) by addressing both inflammatory flares and neurodegeneration [2][22] - The drug combines two mechanisms: inhibition of the enzyme DHODH to reduce relapses and MRI lesions, and activation of the Nurr1 protein to protect neurons from degeneration [3][9] Drug Mechanism - Vidofludimus calcium targets inflammation by inhibiting DHODH, which helps reduce hyperactivated immune cells responsible for relapses and inflammatory brain lesions [6][7] - The neuroprotective aspect involves activating Nurr1, which is linked to nerve survival and the regulation of microglia, the guardians of the central nervous system [8][9] Clinical Trials and Efficacy - In the EMPhASIS Phase 2 trial, vidofludimus calcium demonstrated a 71%-78% reduction in certain lesion measures over 24 weeks and a significant reduction in disability worsening [10][11] - The CALLIPER Phase 2 study showed a 24% reduction in the risk of confirmed disability worsening in the overall population, with a 31% reduction in primary progressive MS patients [12][13] Market Potential - The fully de-risked market for vidofludimus calcium is estimated to be between $3 billion and $7 billion, indicating significant commercial potential [20] - The company raised $65 million in an oversubscribed funding round, reinforcing investor confidence [20] Future Developments - Two global Phase 3 trials, ENSURE-1 and ENSURE-2, have completed enrollment, with results expected by the end of 2026 [14][19] - The company is engaging with regulators to discuss the potential for a Phase 3 study, particularly in primary progressive MS [20][22]