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Minzasolmin

Generic Name
Minzasolmin

UCB Showcases Promising Neurodegenerative Disease Research at AD/PD 2025

• UCB presented 8 scientific abstracts at AD/PD 2025, including subgroup analysis of bepranemab's TOGETHER trial for Alzheimer's disease, the first anti-tau therapy showing clinical efficacy. • The company's Parkinson's disease research program features UCB7853, an anti-alpha-synuclein antibody, and glovadalen (UCB0022), an oral D1 receptor positive allosteric modulator designed for improved symptom control. • Despite ORCHESTRA trial for minzasolmin not meeting clinical endpoints in early-stage Parkinson's disease, UCB continues advancing multiple therapeutic approaches targeting underlying disease mechanisms and symptom management.

Inhibikase Halts Parkinson's Drug Development Following Phase II Trial Setback

• Inhibikase Therapeutics discontinues development of risvodetinib for Parkinson's disease after Phase II trial fails to show significant efficacy despite meeting safety endpoints. • While the drug showed modest improvements in specific measures, including a 1.41-point improvement in MDS-UPDRS Part 2 scores at 100mg dosage, it failed to meet the primary functional endpoints. • The company will pivot to focus on IkT-001Pro for pulmonary arterial hypertension, marking another setback in the challenging landscape of Parkinson's drug development.

APAC Leads Global Parkinson's Disease Clinical Trial Landscape

• The Asia-Pacific region leads in Parkinson's disease clinical trials, accounting for 44% of global trials, with China having the majority share since 2019. • North America follows with 26% of global trials, with the US contributing the most, while Europe hosts 25% of trial activity, led by the UK. • Parkinson's disease trials show regional differences in recruitment metrics, with the US having the longest mean trial duration and Europe showing high recruitment efficiency. • GlobalData projects a 1.94% annual growth rate in diagnosed prevalent cases of Parkinson’s disease in major markets between 2023 and 2033.

Prasinezumab Phase IIb Trial Fails Primary Endpoint, Shows Promise in Parkinson's Subgroup

• Genentech's prasinezumab Phase IIb PADOVA study in early-stage Parkinson's missed its primary endpoint of delaying motor progression. • A pre-specified analysis showed a more pronounced effect in patients treated with levodopa (HR=0.79), suggesting a potential benefit in this subgroup. • The investigational monoclonal antibody continues to be well-tolerated, with ongoing open-label extension studies to further explore observed effects. • Roche plans to present full PADOVA study results at an upcoming medical meeting and will work with health authorities to determine next steps.

UCB's Minzasolmin Fails Phase 2 ORCHESTRA Trial for Early Parkinson's Disease

• UCB's minzasolmin, an oral alpha-synuclein misfolding inhibitor, did not meet primary or secondary endpoints in the Phase 2 ORCHESTRA trial for early Parkinson's. • The ORCHESTRA study enrolled over 450 patients to assess minzasolmin's efficacy, safety, tolerability, and pharmacokinetics over 12-18 months. • UCB will terminate the extension phase of the minzasolmin program and shift focus to glovadalen (UCB0022) and UCB7583 for Parkinson's treatment. • Analysis of disease biomarker data from the ORCHESTRA study is ongoing, with findings to be submitted for publication in a peer-reviewed journal.

Parkinson's Disease Research Focuses on Disease-Modifying Therapies

• The Parkinson's disease (PD) therapeutic market faces unmet needs, notably the absence of neuroprotective/disease-modifying therapies (DMTs) and treatments for non-motor symptoms. • A significant portion of the PD drug development pipeline is dedicated to neuroprotective and disease-modifying agents, targeting mechanisms like alpha-synuclein aggregation and neuroinflammation. • Clinical trials are underway for therapies addressing postural instability, PD-dementia, and cognitive/emotional impairments, reflecting a comprehensive approach to managing PD's complexities.
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