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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.
Krystof Bankiewicz, Scientific Chair, Parkinson's and MSA at AskBio is “encouraged by these early data.”
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.
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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