Bayer subsidiary Asklepios BioPharmaceutical (AskBio) has announced the commencement of subject recruitment in the Phase II REGENERATE-PD clinical trial of AB-1005 to treat moderate-stage Parkinson’s disease.
AB-1005 is a neurotrophic factor (GDNF) gene therapy derived from the adeno-associated virus 2 (AAV2) glial cell line.
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The double-blind, randomised, surgery-controlled trial is designed to assess the safety and efficacy of the therapy in adults aged 45 to 75 years with moderate stage Parkinson’s disease.
In the trial, patients will receive either a single dose of bilateral image-guided infusion therapy into the putamen (active treatment arm), or bilateral partial burr/twist holes (control arm).
A total of 87 participants are anticipated to be enrolled at study sites in the UK, US, and Europe.
AskBio Parkinson’s and MSA scientific chair Krystof Bankiewicz said: “Following the encouraging results from the Phase Ib study and the presentation of 18-month data at the American Association of Neurology (AAN) meeting in April, we are excited to be progressing AB-1005 to this larger, Phase II study.
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By GlobalData“This latest advancement highlights our confidence in the potential of AB-1005 to provide a transformative impact for patients with Parkinson’s disease.”
The company reported data from the Phase Ib trial, which assessed the safety of a one-time bilateral delivery of AB-1005 to the putamen, in January this year.
The trial had met its primary endpoint, with the gene therapy demonstrating to be well tolerated without any serious adverse events.
Apart from the Parkinson’s disease indication, AskBio is enrolling US patients with the parkinsonian subtype of multiple system atrophy (MSA-P) in a Phase I trial.
This Phase I trial is designed to evaluate the initial safety, tolerability, and efficacy of AB-1005 for MSA-P.
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