Clinical TrialJun 26, 2026, 04:13 PM
Monopar ALXN1840 Phase 3 FoCus shows greater neurologic benefit
AI Summary
Monopar Therapeutics announced new analyses from its Phase 3 FoCus trial for ALXN1840 (tiomolibdate choline) in Wilson disease patients. The data, presented at EAN 2026, demonstrated greater neurologic and global clinical benefit compared to standard of care, along with a favorable safety profile. These results further support the company's planned New Drug Application submission to the FDA in mid-2026.
Key Highlights
- ALXN1840 showed significant neurologic improvement (UWDRS Part III, p=0.006) vs. SoC (p=0.435).
- Global clinical improvement (CGI-I) was significantly greater with ALXN1840 (p<0.001).
- Greater proportion of ALXN1840 patients achieved UWDRS Part III improvement at Week 48.
- ALXN1840 showed similar or greater improvement in psychiatric and hepatic measures.
- Favorable safety profile in 266 patients over median 2.58 years, max 8 years.
- Drug-related serious adverse events occurred in 4.9% of patients.
- Neurologic serious adverse events were less than 1%, with no treatment-related deaths.
- Findings support planned New Drug Application (NDA) submission to FDA in mid-2026.
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