Monopar Therapeutics Inc. (MNPR), on Monday announced that Hepatology Communications has published a peer-reviewed manuscript entitled "Effect of Tiomolibdate Choline on Copper Balance in Patients with Wilson Disease: an Open-label Phase 2 Trial." reporting Phase 2 results for ALXN1840 in Wilson disease.
Wilson disease is a rare, progressive genetic condition in which excess copper cannot be removed from the affected individual's blood, leading to a toxic build-up of copper in the liver and brain.
ALXN1840 (tiomolibdate choline) is a novel first-in-class Albumin Tripartite Complex (ATC) activator that mobilizes and sequesters copper, suppressing its redox reactivity and limiting its transport across the blood-brain-barrier.
The Phase 2 trial for ALXN1840 was an open-label, single-arm study conducted in nine patients with Wilson disease and demonstrated a rapid, statistically significant and sustained reduction in daily copper balance, measured by fecal copper excretion. A cumulative mean decrease of -6.08 mg in copper balance was observed in patients receiving a daily dose over 21 days. The drug also demonstrated an approximately 50% increase in daily fecal output-to-intake ratio, and immediate increases in plasma copper and directly measured non-ceruloplasmin-bound copper (dNCC).
ALXN1840 was generally well-tolerated with no serious adverse events reported.
The drug has also been evaluated in a completed 48-week Phase 3 trial, which tested ALXN1840 in 266 patients, and showed significantly greater copper mobilization compared to standard-of-care treatments, including in patients previously treated for more than a decade.
MNPR closed Tuesday at $55.20, down 1.89%. In the overnight market, shares are trading at $57.95, up 4.98%.
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