Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company fully owned by Bayer AG, announced today that the FDA has granted Fast Track Designation for AB-1005, intended for moderate Parkinson’s disease. AB-1005 has also received the Innovation Passport designation from the UK MHRA for its innovative approach to treating Parkinson’s disease.
AB-1005 is an investigational neurorestorative gene therapy using adeno-associated virus 2 glial cell line-derived neurotrophic factor (AAV2-GDNF), aimed at treating moderate Parkinson’s disease. Earlier this year, AskBio reported positive results from its Phase Ib clinical trial, demonstrating the safety of a one-time bilateral delivery of AB-1005 directly to the putamen over 18 months.
Dr. Krystof Bankiewicz, Scientific Chair for Parkinson’s and MSA at AskBio, emphasized the significance of these designations in addressing the unmet needs of Parkinson’s disease patients and praised regulatory bodies for supporting accelerated development of AB-1005.
The FDA Fast Track Program expedites the review and development of therapeutics for serious conditions with unmet medical needs, providing benefits such as more frequent FDA meetings and potential eligibility for Accelerated Approval and Priority Review.
The UK MHRA Innovation Passport enables faster market entry through the Innovative Licensing and Access Pathway (ILAP), offering tailored regulatory guidance and development strategies to facilitate early patient access.
Dr. Canwen Jiang, Chief Development Officer and Chief Medical Officer at AskBio, highlighted their commitment to advancing AB-1005 through the Phase II REGENERATE-PD trial, currently enrolling patients in the U.S. with plans to expand into the EU and UK later this year.
Christian Rommel, Global Head of Research & Development at Bayer’s Pharmaceuticals Division, expressed enthusiasm about leveraging the FDA and MHRA designations to accelerate AB-1005’s development, underscoring the demand for innovative therapies like gene therapy in Parkinson’s disease.
AB-1005 remains investigational and has not been approved by any regulatory authority. AskBio is also investigating GDNF therapy for the parkinsonian subtype of multiple system atrophy (MSA-P) in a Phase I trial in the U.S.
