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TAIPEI, July 28, 2026 /PRNewswire/ -- Dasher Neuroscience Holdings Inc. (TPEx: 7829) ("Dasher Neuroscience"), an AI-driven biopharmaceutical company focused on central nervous system (CNS) drug discovery and development, today announced that it has successfully completed patient enrollment in its global, multi-center Phase 2 clinical trial evaluating YA-101, its flagship candidate for the treatment of Multiple System Atrophy (MSA).
Dasher Neuroscience Holdings Inc.
Top-line clinical data from the trial are expected in the first quarter of 2027. In parallel, Dasher Neuroscience is actively pursuing global out-licensing partnerships while concurrently planning a global multi-center Phase 3 trial to accelerate YA-101 toward clinical commercialization as a potential first-in-class therapy for MSA.
"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."
90 Patients Enrolled Across U.S., Japan, and Taiwan Sites
The Phase 2 trial of YA-101 is a global, multi-center, double-blind, placebo-controlled, dose-escalation study. A total of 90 participants have been enrolled across clinical sites in the United States, Japan, and Taiwan.
The trial aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of 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 of the trial is the incidence and severity of Adverse Events (AEs) 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 Rating Scale (UMSARS) and the 10-Meter Walk Test.
U.S. FDA Fast Track and Global Orphan Drug Designations
YA-101 is a New Chemical Entity (NCE) and a D-amino acid oxidase inhibitor (DAOI) that can inhibit inflammatory cytokines, primarily by reducing neuroinflammation and enhancing neuroplasticity to improve disease outcomes. It is being developed with the potential to serve as a novel treatment option for MSA patients worldwide.
YA-101 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.
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—representing a critical unmet medical need worldwide.
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.
About Dasher Neuroscience Holdings Inc.
Dasher Neuroscience-KY (TPEx: 7829) was listed on the Taiwan Emerging Stock Board on June 3, 2025. It is a biopharmaceutical company focused on using AI to accelerate CNS therapies. （Related： AGIBOT's WITA-Omni Preview Tops Daily-Omni Audio-Visual Reasoning Benchmark ｜ Latest ）
The company's flagship drug, YA-101, initially targets MSA and is currently in Phase II clinical trials. It has received U.S. FDA Fast Track Designation and ODD in the U.S., Japan, and the EU. Additionally, YA-102 for the treatment of Parkinson's disease is under development, along with two preclinical pipeline candidates: YA-201 for Alzheimer's disease and YA-301 for schizophrenia. Upholding its mission to solve unmet medical needs, the company focuses on providing innovative, safe, and effective therapeutic choices. For more information, please visit the company website: www.dasherneuroscience.com.
