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Monopar Presents New Analyses of Phase 3 FoCus Data at EAN 2026 Showing Greater Neurologic and Global Clinical Benefit with ALXN1840 Versus Standard of Care in Wilson Disease

MNPR
  • Monopar Therapeutics Inc. announced that new analyses from the Phase 3 FoCus trial of ALXN1840 (tiomolibdate choline) will be presented at the 12th Congress of the European Academy of Neurology (EAN 2026) in Geneva from June 27–30, 2026.
  • The presentation, titled "Greater clinical benefit with tiomolibdate choline versus standard of care in neurologic Wilson disease patients in the Phase 3 FoCus Trial," will be delivered by Aurélia Poujois, MD, PhD.
  • In the 2:1 randomized Phase 3 FoCus trial subset of 207 patients with baseline neurologic symptoms, ALXN1840 demonstrated significant neurologic improvement over time on the Unified Wilson Disease Rating Scale (UWDRS) Part III (p=0.006), unlike standard of care (p=0.435).
  • Global clinical improvement assessed by the Clinical Global Impressions – Improvement (CGI-I) scale at Week 48 was significantly greater with ALXN1840 compared to standard of care (p<0.001).
  • A greater proportion of patients treated with ALXN1840 achieved improvement on the UWDRS Part III at Week 48 across multiple thresholds compared to standard of care.
  • ALXN1840 produced similar or better outcomes than standard of care across psychiatric and hepatic measures during the 48-week study.
  • Across Phase 2 and Phase 3 studies involving 266 patients, ALXN1840 showed a favorable safety profile with drug-related serious adverse events occurring in 4.9% of patients, neurologic serious adverse events in less than 1%, and no treatment-related deaths.
  • These findings support Monopar Therapeutics' planned New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for ALXN1840 in mid-2026.
  • ALXN1840 is a first-in-class albumin tripartite complex (ATC) activator that mobilizes excess copper, suppresses redox reactivity, limits oxidative damage, and blocks transport across the blood-brain barrier in Wilson disease patients.
  • Monopar Therapeutics also continues development of radiopharmaceutical programs including MNPR-101-Zr, MNPR-101-Lu, and MNPR-101-Ac for advanced cancers.