Bayer and Asklepios BioPharmaceutical (AskBio) have announced US Food and Drug Administration (FDA) fast track designation for AB-1005, a gene therapy to treat moderate Parkinson’s disease (PD).
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has awarded AB-1005 its Innovation Passport for the same indication.
AB-1005 is an investigational adeno-associated virus 2 glial cell line-derived neurotrophic factor (AAV2-GDNF) neurorestorative gene therapy.
It is being studied for its potential to treat moderate PD, a progressive neurodegenerative disorder characterised by the death of nerve cells in the brain, which leads to decreased dopamine levels.
In early 2024 AskBio, a gene therapy company fully owned and independently operated as a subsidiary of Bayer, presented the 18-month Phase Ib clinical trial results for AB-1005.
The trial met its primary objective of assessing the safety of a one-time bilateral delivery of AB-1005 directly to the putamen [the outer part of the lentiform nucleus of the brain].
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AskBio chief development officer and chief medical officer Canwen Jiang stated: “The FDA fast track and the UK MHRA Innovation Passport designations represent important accomplishments for the clinical development of AB-1005 and receiving these highlights our goal of bringing a safe neurorestorative treatment to patients with moderate Parkinson’s disease.
“We look forward to advancing our Phase II REGENERATE-PD clinical trial, which is currently enrolling patients in the U.S. with sites in the European Union and UK planned to open later this year.”
Bayer’s Pharmaceuticals Division global head of research and development Christian Rommel stated: “We are excited about the opportunity to potentially accelerate the development of AB-1005, leveraging the frequent interaction with relevant regulatory bodies.
“The granted designations for AB-1005 highlight the demand to advance novel therapeutic modalities, like gene therapy, for people living with the debilitating effects of Parkinson’s disease.”
AskBio is investigating the potential of GDNF therapy for conditions other than PC. The company is currently enrolling patients in the US with the Parkinsonian subtype of multiple system atrophy in a Phase I trial.
