Dasher Neuroscience Completes Patient Enrollment in Phase 2 Trial of YA-101 for Multiple System Atrophy
核心洞察
Dasher Neuroscience has completed enrollment of 90 patients in its global Phase 2 trial of YA-101 for Multiple System Atrophy (搜索) across sites in the U.S., Japan, and Taiwan.
The double-blind, placebo-controlled, dose-escalation study will evaluate safety, tolerability, pharmacokinetics, and efficacy, with top-line data expected in Q1 2027.
YA-101, a D-amino acid oxidase (搜索) inhibitor, has received FDA Fast Track Designation and Orphan Drug Designation in the U.S., Japan, and the European Union.
Dasher Neuroscience Holdings Inc. (搜索) (TPEx: 7829) announced today the successful completion of patient enrollment in its global, multi-center Phase 2 clinical trial evaluating YA-101, the company's flagship drug candidate for the treatment of Multiple System Atrophy (搜索) (MSA). Top-line clinical data from the trial are expected in the first quarter of 2027, and the company is actively pursuing global out-licensing partnerships while planning a Phase 3 trial.
"Completing patient enrollment in this global Phase 2 trial represents a major milestone in advancing our lead candidate, YA-101, toward commercialization," said Dr. Jane Tseng, Chief Executive Officer of Dasher Neuroscience. "This study will provide critical data on both the safety and clinical efficacy of YA-101, laying a solid foundation for licensing discussions with potential global partners as we work to bring this innovative therapy to rare disease patients facing significant unmet medical needs."
Trial Design and Endpoints
The Phase 2 trial is a global, multi-center, double-blind, placebo-controlled, dose-escalation study that enrolled a total of 90 participants across clinical sites in the United States, Japan, and Taiwan. The study evaluates YA-101 in patients aged 30 and older diagnosed with MSA according to Movement Disorder Society (MDS) clinical criteria, encompassing both the Parkinsonian subtype (MSA-P) and cerebellar subtype (MSA-C).
The primary endpoint is the incidence and severity of Adverse Events (AEs), designed to assess the safety and tolerability profile of YA-101. Secondary endpoints include pharmacokinetic (PK) parameters, as well as clinical efficacy evaluated via the Unified Multiple System Atrophy (搜索) Rating Scale (UMSARS) and the 10-Meter Walk Test.
Mechanism of Action and Regulatory Status
YA-101 is a New Chemical Entity (NCE) and a D-amino acid oxidase (搜索) inhibitor (DAOI) that can inhibit inflammatory cytokines, primarily by reducing neuroinflammation and enhancing neuroplasticity to improve disease outcomes. The candidate has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA), alongside Orphan Drug Designation (ODD) from regulatory agencies in the U.S., Japan, and the European Union.
Unmet Need in Multiple System Atrophy
MSA is a rare, rapidly progressive, and fatal neurodegenerative disease. Onset typically occurs in a patient's 50s, with up to 80% of patients becoming severely disabled within 5 years of diagnosis and a mean survival of just 6 to 10 years. Current clinical management is limited to symptomatic relief, with no approved disease-modifying therapies available.
The global prevalence of MSA is approximately 5 cases per 100,000 individuals, affecting an estimated 15,000 to 50,000 individuals in the U.S., 18,000 to 70,000 in the EU, 12,000 in Japan, and 2,000 in Taiwan. Upon regulatory approval, YA-101 aims to fill this severe treatment gap and offer new therapeutic hope to patients worldwide.
Company Background
Dasher Neuroscience-KY (TPEx: 7829), listed on the Taiwan Emerging Stock Board on June 3, 2025, is an AI-driven biopharmaceutical company focused on central nervous system (CNS) drug discovery and development.