Clinical TrialMay 19, 2026, 05:34 PM
Monopar's ALXN1840 Phase 2 Results Show Significant Copper Balance Improvement
AI Summary
Monopar Therapeutics announced the publication of peer-reviewed Phase 2 trial results for ALXN1840 (tiomolibdate choline) in Hepatology Communications. The study demonstrated that ALXN1840 rapidly and significantly improved daily copper balance in patients with Wilson disease, driven by increased fecal copper excretion. These positive findings, including good tolerability and efficacy even in previously treated patients, reinforce ALXN1840's potential as a new treatment option for this rare genetic condition.
Key Highlights
- ALXN1840 produced a rapid, statistically significant, and sustained improvement in daily copper balance.
- Cumulative mean decrease from baseline in copper balance of -6.08 mg over 21 days (95% CI: -10.18 mg to -1.98 mg).
- Mean daily copper balance change from baseline of -0.37 mg (p=0.005) during 15 mg/day treatment.
- Approximately 50% increase in daily fecal copper output-to-intake ratio compared to baseline (p=0.041).
- Immediate increases in plasma total copper and non-ceruloplasmin-bound copper, consistent with copper mobilization.
- ALXN1840 was generally well tolerated with no serious adverse events reported.
- Improvements observed in patients with mean prior standard of care treatment duration of 16 years.
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