AskBio, a Bayer AG subsidiary, announced that its investigational gene therapy AB-1005 for Parkinson’s disease received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA.
This designation was based on promising Phase Ib trial data, showing a favorable safety profile and positive trends in clinical outcomes.
The RMAT designation aims to expedite the development of AB-1005 through enhanced access to the FDA.
AB-1005 is currently in a Phase II clinical trial, REGENERATE-PD, to assess its efficacy and safety in adults with moderate-stage Parkinson’s.
Parkinson’s disease affects millions worldwide, and there is no cure for it.
AskBio focuses on developing innovative gene therapies, and Bayer is committed to advancing healthcare solutions.
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