Aspen Neuroscience has launched Cohort 3 of its ASPIRO Phase 1/2a clinical trial for ANPD001, its autologous dopaminergic neuronal precursor cell (DANPC) therapy for Parkinson’s disease, the company announced.
Cohort 3 marks the first use of Aspen’s commercial formulation of ANPD001, which the company said is designed to enable scalable, reproducible manufacturing and seamless clinical deployment. According to the company, the new formulation is preclinically comparable to earlier versions used in Cohorts 1 and 2, supporting continuity as the trial progresses.
Earlier data from the first two cohorts reportedly showed favorable safety and tolerability over six months, along with clinician- and patient-reported improvements, achieved without immunosuppression. The company claims the new formulation allows cryopreserved cells to be dosed immediately upon arrival at clinical sites, reducing logistical demands on hospital cell processing labs.
Aspen describes its platform as built on three pillars: a proprietary manufacturing process converting patient skin cells into DANPCs via machine learning tools; the autologous iPSC-derived therapeutic approach; and a precision delivery device combining MRI guidance and metered dosing for submillimeter surgical accuracy.
ASPIRO is testing safety, tolerability and preliminary efficacy of ANPD001 in levodopa-responsive patients aged 50–70, with primary endpoints at 12 months and follow-up extending to 15 years. The company said ANPD001 has received Fast Track designation from the U.S. Food and Drug Administration.
