Bayer and its subsidiary Asklepios BioPharmaceutical (AskBio) have reported data from an 18-month Phase Ib clinical trial of a gene therapy, AB-1005, aimed at treating Parkinson’s disease (PD).
The multicentre, multi-site non-randomised, parallel assignment study enrolled 11 PD patients.
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AB-1005 was administered to the putamen through a one-time bilateral convection-enhanced delivery.
Trial subjects were divided into two cohorts based on the stage of their PD: mild (six patients) and moderate (five patients).
The objective of the trial was to assess the safety and clinical impact of the AB-1005 gene therapy.
According to the findings, the study met its primary goal in January this year.
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By GlobalDataAs of 3 November last year, 57 nonserious adverse events (AEs) and six serious adverse events (SAEs) were reported in the study, with most AEs being transient and expected perioperative events.
The bilateral infusions of the therapy within the putamen were found to be well tolerated, without any SAEs linked to the gene therapy or contrast agent.
The mild cohort showed relative stability from baseline to 18 months according to their Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part II subject-reported Activities of Daily Living scores and Part III clinician-rated Motor Examination scores in ‘ON’ and ‘OFF’ medication states.
There was a -1.3 hour reduction in ‘Good ON’ time, a 0.2 hour rise in ‘ON’ time with troublesome dyskinesia, and a 1.1 hour rise in ‘OFF’ time.
In contrast, the Moderate Cohort exhibited significant improvements in both Activities of Daily Living and Motor Examination scores.
The cohort displayed a -20.4-point improvement in the ‘OFF’ medication state and an improvement of -10.6 points ‘ON’ medication, compared to baseline.
These outcomes suggest that the Mild Cohort maintained overall clinical stability while the Moderate Cohort experienced motor improvements at 18 months.
Based on these results, a REGENERATE PD Phase II trial is scheduled to begin subject enrolment in the US, EU, and UK later this year.
AskBio Parkinson’s and MSA Scientific chair Krystof Bankiewicz said: “These early findings are encouraging and show AB-1005 to be well tolerated in this study in patients with mild to moderate Parkinson’s disease.
“Further, they highlight areas of potential future exploration in our upcoming Phase II REGENERATE PD trial, which will look more closely at the potential efficacy of AB-1005 in the treatment of Parkinson’s disease.”
