Aspen Neuroscience presented 12-month safety, tolerability and efficacy data from its Phase 1/2a ASPIRO trial at the AD/PD 2026 conference in Copenhagen. The first-in-human, open-label, multi-center study enrolled Parkinson’s patients aged 50–70 and the presentation reported outcomes from the first eight treated patients, four receiving a low dose and four a higher dose.
According to the company, at 12 months both dosing cohorts showed numerical improvements in function, clinician- and patient-reported outcomes, and quality of life, including mean Good ON time (+2.1 hours low dose, +2.4 hours high dose), mean MDS-UPDRS III OFF scores (-15.5 points low dose, -13.5 points high dose), mean MDS-UPDRS II scores (-5.3 points low dose, -2.3 points high dose), and mean PDQ-39 improvement (51.6% low dose, 28.5% high dose). Several patients had these improvements alongside reductions in levodopa equivalent daily dose.
FDOPA PET imaging showed cell survival and engraftment. The company reported no serious surgical adverse events, no severe graft-induced dyskinesia, and no symptomatic hemorrhages or infarctions; intraoperative imaging confirmed accurate placement. Sasineprocel (ANPD001) has an FDA Fast Track designation, and the study received CIRM funding. According to the company, it plans to advance Sasineprocel to a Phase 3 study later this year.
