Aspen Neuroscience Launches Cohort 3 in Parkinson’s Trial with Commercial-Ready ANPD001

Aspen Neuroscience, Inc., a clinical-stage biotech developing autologous regenerative therapies, announced the start of Cohort 3 in its ASPIRO Phase 1/2a trial of ANPD001 for Parkinson’s disease (PD).

This milestone marks the first use of Aspen’s commercial-ready formulation of ANPD001, engineered for scalability, reproducibility, and streamlined hospital workflows.

Cohort 3: A Step Toward Commercial Readiness

• Continuity assured – The new formulation is preclinically comparable to earlier cohorts.
• Streamlined delivery – Cryopreserved cells are ready for dosing immediately on arrival, easing the burden on hospital labs.
• Positive foundation – Previous cohorts showed strong safety, tolerability, and early efficacy signals without immunosuppression.

“Cohort 3 represents an important step toward commercial readiness. We’ve optimized our formulation and delivery system to meet the demands of late-stage development and future market access.”

• Damien McDevitt, Ph.D., President and CEO.

The Three Pillars of Aspen’s Approach

Aspen’s commercial formulation reflects an integrated innovation platform:

• Manufacturing Platform – Converts patient skin cells into dopaminergic neuronal precursor cells (DANPCs) using machine learning for consistent quality.
• Therapeutic Platform – ANPD001 is an autologous iPSC-derived DANPC therapy that avoids immune rejection and immunosuppression.
• Proprietary Delivery Device – Precision transplantation with metered dosing and MRI guidance ensures sub-millimeter accuracy and minimally invasive surgery.

“Together, these three pillars form a platform that is personalized, precise, and scalable.”

• Lisa Johnson-Pratt, M.D., EVP, Therapeutic Program Lead.

Why ANPD001 Stands Out

Unlike allogeneic therapies that rely on donor cells, ANPD001 uses a patient’s own cells. This eliminates the need for immunosuppressive drugs, avoids related side effects, and opens eligibility for patients contraindicated for IS therapy.

With over 1 million people in the U.S. living with Parkinson’s and no disease-modifying therapies available, ANPD001 offers the potential to restore lost dopaminergic function—with curative intent.

About ANPD001

• Most advanced autologous PD therapy in the U.S.
• FDA Fast Track designation granted.
• Developed from a patient’s skin cells, reprogrammed into iPSCs, and differentiated into DANPCs.
• Transplanted into the posterior putamen to replace damaged or lost neurons.
• Quality safeguarded with Aspen’s machine learning–based genomic tests at every stage.

About the ASPIRO Trial

ASPIRO is the first multi-patient, multi-center trial of an autologous cell therapy for Parkinson’s. It evaluates safety, tolerability, and early efficacy of ANPD001 in levodopa-responsive patients aged 50–70.

• Primary endpoints: 12 months.
• Long-term follow-up: Up to 15 years.
• ClinicalTrials.gov ID: NCT06344026.

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