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AskBio Secures FDA Fast Track and MHRA Innovation Passport Designations for AB-1005 Investigational GDNF Gene Therapy for Parkinson’s Disease

NextEdge Admin

12 Jul 2024

3 min 15 sec

Bayer AG and its subsidiary Asklepios BioPharmaceutical, Inc. (AskBio) have announced that the U.S. FDA has granted Fast Track Designation for AB-1005, a gene therapy for moderate Parkinson’s disease. Additionally, the UK MHRA has awarded AB-1005 the Innovation Passport, a designation for innovative medicines.

AB-1005 is an investigational adeno-associated virus 2 glial cell line-derived neurotrophic factor (AAV2-GDNF) neurorestorative gene therapy. This therapy aims to treat moderate Parkinson’s disease. Earlier this year, AskBio shared positive 18-month Phase Ib clinical trial results, demonstrating the safety of a one-time bilateral delivery of AB-1005 directly to the putamen.

Dr. Krystof Bankiewicz, Scientific Chair for Parkinson’s and MSA at AskBio, emphasized the importance of these regulatory designations in addressing the significant unmet need in Parkinson’s disease treatment. The FDA Fast Track Program accelerates the development and review process for therapies targeting serious conditions with unmet medical needs, enabling earlier patient access. Benefits include more frequent FDA meetings and potential eligibility for Accelerated Approval and Priority Review.

The UK MHRA Innovation Passport is the initial step in the Innovative Licensing and Access Pathway (ILAP), which aims to expedite market entry and patient access. Innovation Passport holders collaborate with the UK MHRA to create Target Development Profiles (TDP), defining key regulatory features, identifying potential challenges, and outlining a roadmap for early patient access.

Dr. Canwen Jiang, Chief Development Officer and Chief Medical Officer at AskBio, highlighted the significance of these accomplishments for AB-1005’s clinical development. The ongoing Phase II REGENERATE-PD clinical trial is currently enrolling patients in the U.S., with plans to expand to the EU and UK later this year. Dr. Christian Rommel, Global Head of Research & Development at Bayer’s Pharmaceuticals Division, expressed excitement about accelerating AB-1005’s development through frequent regulatory interactions.

AB-1005 remains investigational, with its efficacy and safety yet to be fully established. AskBio is also investigating GDNF therapy for other conditions, including multiple system atrophy (MSA-P), with a Phase I trial currently enrolling patients in the U.S.