AskBio’s (Bayer's Subsidiary) AB-1005 Gains the US FDA’s Fast Track and MHRA’s Innovation Passport Designations for Parkinson’s Disease
Shots:
- Bayer & AskBio (Bayer’s subsidiary) has received the US FDA’s Fast Track Designation along with UK MHRA’s Innovation Passport for treating Parkinson’s disease
- The 18mos. P-Ib study of AB-1005 (AAV2-GDNF gene therapy) for Parkinson’s disease reached its primary safety objective for a one-time bilateral delivery to the putamen
- Moreover, the company is recruiting patients for P-I study evaluating the preliminary safety, tolerability, and efficacy of AB-1005 for parkinsonian subtype of multiple system atrophy (MSA-P) across the US and for P-II (REGENERATE-PD) study across the US with its extension to EU & UK planned in H2’24
Ref: Bayer | Image: Bayer
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
