Yoda Therapeutics announced on the 26th that its new drug YA-101, targeting Multiple System Atrophy (MSA), has completed the first dose administration to a patient in its Phase II clinical trial in the United States.
Multiple System Atrophy (MSA) is a rare and rapidly progressing neurodegenerative disease that leads to severe motor dysfunction, including Parkinsonian and cerebellar ataxia subtypes, often accompanied by autonomic nervous dysfunction, which significantly impacts the patient's quality of life. Currently, there are no treatments that can reverse or delay the progression of MSA, and existing symptom management options only provide limited relief without offering long-term solutions.
YA-101 is a new chemical entity (NCE) specifically designed to treat neurodegenerative diseases by inhibiting neuroinflammation and enhancing neuroplasticity, aiming to improve the condition. The drug has already completed Phase I clinical trials in healthy volunteers in Australia, demonstrating safety and tolerability. It is now entering Phase II trials for MSA patients, which will be conducted at multiple clinical trial centers in the United States and Taiwan. This trial is randomized, double-blind, and placebo-controlled, enrolling MSA patients with walking abilities, including those requiring assistive devices, to evaluate the safety, tolerability, pharmacokinetics, and efficacy of YA-101. The clinical trial will comprehensively assess clinical endpoints, biomarkers, and imaging data.
CEO Yu-Feng Tseng stated that Yoda Therapeutics is an AI-driven biotechnology company focused on the development of central nervous system drugs. YA-101 is designed specifically for treating neurodegenerative diseases with a dual-regulatory mechanism. The drug has shown improvements in motor-related behavioral disorders, such as ataxia and MSA, in preclinical animal models and has demonstrated good safety and tolerability in healthy adults during Phase I clinical trials. On July 1, 2022, YA-101 received orphan drug designation (ODD) from the U.S. FDA for MSA.
Resource: 思捷優達 治多重系統退化症新藥 二期臨床試驗啟動收案
