Yoda Therapeutics-KY announced on the 2nd that its subsidiary’s application for a Phase II clinical trial of YA-101, a new drug candidate for the treatment of Multiple System Atrophy (MSA), has been approved by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). This follows previous approvals by the U.S. Food and Drug Administration (FDA) and Taiwan’s Food and Drug Administration (TFDA) last year.

This trial is a multinational, multi-center Phase II global study expected to enroll 75 patients. Initially, trial sites were located in Taiwan and the United States, encompassing a total of eight medical centers. With PMDA’s approval, Japan becomes the third regulatory body to authorize the trial. The primary endpoint is safety, with secondary endpoints including pharmacokinetics (PK), the Unified Multiple System Atrophy Rating Scale (UMSARS), and the 10-meter walk test. Patient enrollment is expected to be completed by 2026.

Yoda Therapeutics CEO Anita Tseng stated that the approval from Japan marks a significant milestone in the company’s global development plan, and affirms the team’s strong expertise and execution capabilities in the field of neurodegenerative diseases. She added that Yoda will continue to pursue a steady and forward-looking strategy in advancing drug development and clinical progress, with the ultimate goal of delivering meaningful treatment options to patients.

Resource: 思捷優達-KY MSA二期臨床試驗獲日本PMDA核准，目標2026年完成收案