Aspen presented 12-month data from the first eight patients enrolled in its Phase 1/2a ASPIRO trial of Sasineprocel, an autologous iPSC-derived dopaminergic cell therapy for Parkinson’s disease.
Across low- and high-dose cohorts, patients averaged roughly two additional hours of Good on time per day and saw MDS-UPDRS Part III OFF score reductions of about 15.5 and 13.5 points, respectively. Quality-of-life scores on the PDQ-39 improved by 51.6 percent in the low-dose group and 28.5 percent in the high-dose group, the company claims.
FDOPA PET imaging reportedly confirmed cell survival and engraftment. No serious surgical adverse events or severe graft-induced dyskinesia were reported, and several patients reduced their levodopa equivalent daily dose.
The therapy begins with a patient skin biopsy that is reprogrammed into iPSCs and differentiated into dopaminergic neuron precursors for MRI-guided injection into the post-commissural putamen; because the cells are autologous, no chronic immunosuppression is required, the company states.
Aspen says it has established manufacturing assays branded PluriTest, NeuriTest, GraftTest and DopaTest and operates a 14,000 square foot facility in San Diego.
The company closed a $115 million Series C in November 2025 and plans an FDA meeting in the first half of the year to align on a pivotal study and start a Phase 3 trial later in 2026. Aspen flags neurosurgical training and reimbursement, including potential CMS pricing decisions, as the next challenges.
Source: https://www.synbiobeta.com/read/aspens-parkinsons-therapy-shows-compelling-clinical-potential
