Clinical TrialJun 26, 2026, 04:06 PM
Monopar ALXN1840 Phase 3 Shows Significant Neurologic Improvement
AI Summary
Monopar Therapeutics announced new analyses from its Phase 3 FoCus trial for ALXN1840 (tiomolibdate choline) in Wilson disease patients with neurologic symptoms. The data, presented at EAN 2026, showed ALXN1840 produced significant neurologic improvement over time and greater global clinical improvement compared to standard-of-care. The drug also demonstrated similar or better outcomes across psychiatric and hepatic measures, 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, p<0.001) was significantly greater with ALXN1840 than SoC.
- A greater proportion of ALXN1840 patients achieved improvement on UWDRS Part III at Week 48.
- ALXN1840 produced similar or greater improvement than SoC across psychiatric and hepatic measures.
- Favorable safety profile observed in 266 patients with median 2.58 years treatment duration.
- Drug-related serious adverse events occurred in 4.9% of patients, with neurologic SAEs in <1%.
- Findings further support Monopar's planned NDA submission to the FDA for ALXN1840 in mid-2026.
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