AnnJi Pharmaceutical Co., Ltd. is launching the first-in-patient study of AJ201 for the treatment of SBMA (Spinal and Bulbar Muscular Atrophy, or Kennedy’s Disease) to evaluate the safety and clinical responses of AJ201. This study will take place in six clinical sites across the United States and patient recruitment is expected to begin in late December 2022. The study protocol was developed after a discussion with and review by the US Food and Drug Administration (FDA). The Investigational New Drug (IND) Amendment Application for this study was submitted to the US FDA in July 2022 and was allowed to proceed after the 30-day IND review period. Further details about this study can be found at ClinicalTrials.gov (Identifier: NCT05517603).

Dr. Yiumo Michael Chan, VP of Research and Translational Medicine, will introduce this study as the pivotal part of the AJ201 development plan in the upcoming Kennedy’s Disease Association Conference (November 9-11, 2022) to be held in San Diego, California.