Aspen Neuroscience Announces FDA Clearance of Investigational New Drug Application (IND) for ANPD001, Autologous Cell Therapy for the Treatment of Parkinson’s Disease; Aspen Will Initiate First Multicenter Phase 1/2a Clinical Trial of an Autologous iPSC-Based Therapy in the U.S.

On August 8, 2023, Aspen Neuroscience announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application, enabling the company to proceed with a clinical trial for ANPD001, a personalized (autologous) cell therapy to treat Parkinson’s Disease by replacing lost dopamine neurons. Next, Aspen plans to initiate a first-in-patient Phase 1/2a clinical trial for people with moderate to severe Parkinson’s Disease (PD). This follows the company’s 2022 Trial-Ready Screening Cohort Study to screen, enroll, and begin manufacturing cells for potential patient candidates for the clinical trial. This study will be the first multi-center Phase 1/2a trial of an autologous iPSC-derived therapy in the U.S. Aspen’s autologous approach uses induced pluripotent stem cells (iPSCs) developed from the patient’s own skin cells, to manufacture dopamine neuronal precursor cells (DANPCs). These cells are then evaluated for potential activity using robust quality control assays, including Aspen’s proprietary artificial intelligence-based genomics tests, before being implanted.