AskBio gains important designations for AB-1005 development

11 July 2024

The US Food and Drug Administration (FDA) has granted Fast Track designation for AB-1005, which is being developed for moderate Parkinson’s disease by German pharma major Bayer (BAYN: DE) gene therapy subsidiary Asklepios BioPharmaceutical (AskBio).

AB-1005 has also been awarded the Innovation Passport, the UK Medicines and Healthcare products Regulatory Agency (MHRA) innovative medicine designation, for the treatment of Parkinson’s disease.

AB-1005 is an investigational adeno-associated virus 2 glial cell line-derived neurotrophic factor (AAV2-GDNF) neurorestorative gene therapy being studied for the treatment of moderate Parkinson’s disease. Earlier this year, AskBio presented the 18-month Phase Ib clinical trial results for AB-1005, which met its primary objective of evaluating the safety of a one-time bilateral delivery of AB-1005 directly to the putamen.

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