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.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze