AnnJi Pharmaceutical Co., Ltd., a clinical-stage Taiwanese biotechnology company focused on addressing unmet medical needs in dermatology, neurology, and rare diseases, today announced positive results from its Phase 1/2a randomized, double-blind, placebo-controlled, first-in-patient clinical trial of AJ201 in adults with Spinal and Bulbar Muscular Atrophy (SBMA). Conducted across six U.S. clinical sites, the study evaluated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AJ201 (ClinicalTrials.gov Identifier: NCT05517603). While not powered to assess efficacy, exploratory endpoints revealed meaningful treatment-related improvements that support continued clinical development.
Read the news release from AnnJi: Anji Biotech's New Drug AJ201 Has Achieved Impressive Clinical Phase 1b/2a Trial Results, Demonstrating Positive Therapeutic Efficacy and Potential.
Read the KDA News article: First-In-Patient Trial of a Drug to Treat Kennedy’s Disease
Learn more about AJ201 and AnnJi Pharmaceutical Co., Ltd.
Follow-Up News
Read the KDA News article: FDA Grants Fast Track Designation for AJ201
Read the KDA News article: AnnJi Showcases Promising Results for AJ201 in Kennedy’s Disease Clinical Trial
