REGENERATE-PD is a randomized, double-blind, sham-controlled trial assessing the efficacy and safety of intraputaminal AB-1005 in adults aged 45 to 75.

Dr. Rajesh Pahwa, the trial's principal investigator, emphasized the significant need for new neurorestorative therapies for Parkinson's disease.

On January 14, 2025, AskBio Inc. announced the randomization of the first participants in its Phase II clinical trial for Parkinson's disease, known as REGENERATE-PD.

The trial aims to evaluate the safety and efficacy of AB-1005, with an expected enrollment of approximately 87 participants from the US, Germany, Poland, and the United Kingdom.

Christian Rommel noted the importance of AskBio's Parkinson’s program and the potential impact of gene therapy on treatment options for the disease.

Bayer AG, the parent company of AskBio, is a global leader in health care and nutrition, employing around 100,000 people and reporting significant sales and R&D expenditures in 2023.

At the International Congress of Parkinson’s Disease and Movement Disorders, AskBio presented 36-month Phase Ib data, indicating that AB-1005 was well tolerated with no serious adverse events reported.

In addition to its work on Parkinson's disease, AskBio is also exploring the use of AB-1005 for the parkinsonian subtype of multiple system atrophy in a separate Phase I clinical trial.

The company has initiated enrollment for this trial of AB-1005, a gene therapy specifically targeting moderate-stage Parkinson's disease, across clinical centers in the United States and beyond.

Parkinson's disease is a progressive neurodegenerative disorder affecting over 10 million people globally, characterized by motor and non-motor symptoms, with no current cure available.

AB-1005 is an investigational gene therapy utilizing an adeno-associated viral vector to deliver GDNF, a neurotrophic factor that may benefit dopaminergic neurons in the brain.

Current treatments for Parkinson's disease primarily focus on symptom management, highlighting the urgent need for effective new therapies.