•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Monopar Therapeutics Inc. said it has released new analyses from the randomized controlled Phase 3 FoCus trial of ALXN1840 (tiomolibdate choline, TMC), showing greater neurologic benefit versus standard of care (SoC) in Wilson disease patients who had neurologic symptoms at baseline. The company said the data will be presented at the American Academy of Neurology (AAN) Annual Meeting 2026, April 18–22, 2026.
In the late-breaker oral and poster presentation titled “Greater clinical benefit with tiomolibdate choline versus standard-of-care in neurologic Wilson disease patients in the Phase 3 FoCus Trial,” Dr. Peter Hedera, MD, PhD, of the University of Louisville School of Medicine, will present results indicating that ALXN1840 produced greater neurologic improvement and significantly less worsening than standard of care through Week 48, with benefit described as durable over multiple years of treatment.
For the analysis of patients with neurologic symptoms at baseline, the company reported group sizes of TMC: n=77 and SoC: n=35. It said ALXN1840 was associated with higher rates of improvement and lower rates of worsening.
Monopar said durable neurologic benefit in the ALXN1840-treated group continued to increase during long-term follow-up and was sustained over approximately 3 years.
The company also reported that neurologic benefit was consistent across both treatment-naïve and treatment-experienced patients with neurologic symptoms at baseline.
Monopar said ALXN1840 has demonstrated a well-characterized and favorable safety profile across Phase 2 and Phase 3 studies, including 266 patients with a median 2.58 years on treatment and a maximum of more than 8 years. The company reported drug-related serious adverse events (SAEs) limited to 4.9% of patients, including neurologic SAEs in less than 1% of patients, and said there were no treatment-related deaths.
Dr. Hedera said the data highlight ALXN1840’s potential to change the treatment landscape for Wilson disease patients with neurologic symptoms by improving clinical outcomes and reducing the likelihood of neurologic deterioration compared with standard of care.
Monopar said the presentation and poster are available on its website and that the findings support continued advancement of ALXN1840 toward a planned New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) in mid-2026.
Wilson disease is a rare genetic disorder affecting approximately 1 in 30,000 people worldwide. It is caused by mutations in the ATP7B gene, which impairs the body’s ability to excrete copper, leading to toxic accumulation in the liver, brain, and other organs and potentially fatal outcomes if untreated.
ALXN1840 (tiomolibdate choline, TMC) is described as a novel first-in-class Albumin Tripartite Complex (ATC) activator under investigation for Wilson disease. The company said ALXN1840 rapidly mobilizes and tightly sequesters excess copper in ATCs, suppressing redox reactivity, limiting oxidative damage, and blocking transport across the blood–brain barrier. It said clinical data show ALXN1840 improves copper balance by increasing fecal copper excretion, and that in the Phase 3 pivotal trial it demonstrated rapid and sustained copper mobilization (primary endpoint) significantly greater than standard of care over 48 weeks in both previously treated and untreated patients. Monopar also cited durable clinical improvement and a favorable safety and tolerability profile across 645 patient-years of follow-up in 266 patients.
Premium gym chains are entering a “golden era” that is ending or already in decline, as rising operating costs collide with shifting consumer preferences toward more flexible, community-based ways to exercise. Long-term memberships are shrinking, margins are pressured by higher rents and facility expenses, and competition from smaller, more personalized…
