Bayer AG (OTC:BAYRY) (OTC:BAYZF) and Asklepios BioPharmaceutical Inc completed an 18-month data collection in the Phase Ib trial for AB-1005 (AAV2-GDNF), an investigational gene therapy for treating patients with Parkinson’s disease (PD).
The study met its primary objective, which was to evaluate the safety of a one-time bilateral delivery of AB-1005 directly to the putamen.
Eleven patients were enrolled into two cohorts, Mild stage PD (six patients) and Moderate stage PD (5 patients), based upon the timing from a PD diagnosis and the severity of their PD symptoms at screening.
Neurosurgical delivery of AB-1005 was well tolerated by all patients with target putamen coverage of 63% ± 2%, exceeding the goal of greater than 50% coverage with AB-1005.
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No serious adverse events have been attributed to AB-1005, with continued clinical follow-up for up to 5 years post-administration ongoing.
“We are encouraged by these early data, which show AB-1005 to be well tolerated in this study in patients with mild to moderate Parkinson’s disease,” said Krystof Bankiewicz, Scientific Chair, Parkinson’s and MSA, AskBio.
AskBio is planning to present the 18-month study data, including secondary endpoints, at a scientific meeting in Q2 2024. Planning is currently underway for a Phase 2 trial.
The study is expected to begin screening patients soon. The trial design has been harmonized with feedback from U.S. and European health authorities.
In November, Bayer stopped the OCEANIC-AF Phase 3 study investigating asundexian compared to apixaban (a direct oral anticoagulant) in patients with atrial fibrillation at risk for stroke.
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