Advancement of commercial-ready formulation supports scalability and late-stage development

Aspen Neuroscience, Inc., a clinical-stage regenerative medicine biotechnology company developing personalized, autologous cell therapies,  announced completion of dosing in Cohort 3 and Cohort 4 of its ongoing Phase 1/2a ASPIRO clinical trial evaluating sasineprocel (ANPD001) for the treatment of Parkinson's disease (PD).

With the completion of these cohorts, a total of 15 patients have been dosed in the ASPIRO study to date, representing one of the largest clinical experiences reported for an autologous cell therapy in Parkinson's disease.

Cohorts 3 and 4* utilize Aspen's commercial-ready formulation of sasineprocel designed to support scalable, reproducible manufacturing and streamlined clinical delivery. This formulation incorporates a cryopreserved "thaw-and-inject" drug product, enabling cells to be administered upon arrival at the clinical site and increasing procedural efficiency.

"We are proud to reach this important milestone, which reflects meaningful progress in the sasineprocel program and underscores the growing clinical experience with our personalized, autologous approach," said Damien McDevitt, Ph.D., President and Chief Executive Officer of Aspen Neuroscience. "Importantly, the use of our commercial formulation in these cohorts represents a critical step toward scalable manufacturing and commercial readiness as we prepare for Phase 3 initiation."

The ASPIRO study is an open-label Phase 1/2a clinical trial designed to evaluate the safety, tolerability, and potential efficacy of sasineprocel, an autologous induced pluripotent stem cell (iPSC)-derived dopaminergic neuron precursor cell (DANPC) therapy. Sasineprocel is designed to replace and restore damaged neural circuitry in patients with Parkinson's disease without the need for immunosuppressive therapy.

Aspen continues to progress key activities supporting late-stage clinical development, including manufacturing scale-out and process optimization aligned with future pivotal trial requirements.