Monopar Therapeutics to Present ALXN1840 Study Analysis at EAN 2026
Monopar Therapeutics announced that new analyses from the Phase 3 FoCus randomized controlled clinical trial of ALXN1840 will be presented at the 12th Congress of the European Academy of Neurology, or EAN 2026, June 27-30, in Geneva, Switzerland. These analyses build upon the previously reported Phase 3 FoCus results demonstrating ALXN1840 met its primary endpoint of superior copper mobilization versus standard of care. In the subset of patients with neurologic symptoms at baseline from the 2:1 randomized Phase 3 FoCus clinical trial, ALXN1840 demonstrated improved outcomes compared to SoC across multiple clinical measures: Neurologic improvement on the rater-blinded, physician-assessed Unified Wilson Disease Rating Scale Part III was significant and continued over time with ALXN1840 but not with SoC. Global clinical improvement as assessed by the Clinical Global Impressions - Improvement scale at Week 48 was significantly greater with ALXN1840 than with SoC. A greater proportion of patients treated with ALXN1840 achieved improvement on the rater-blinded UWDRS Part III at Week 48 compared with SoC, with consistent results observed across multiple improvement thresholds. ALXN1840 also produced similar or greater improvement than SoC at Week 48 across psychiatric and hepatic measures. Across Phase 2 and Phase 3 studies, ALXN1840 has demonstrated a well-characterized and favorable safety profile in 266 patients, with a median treatment duration of 2.58 years and maximum exposure of more than 8 years. Drug-related serious adverse events occurred in 4.9% of patients, including neurologic SAEs in less than 1% and no treatment-related deaths.
