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MeiraGTx’s Phase II Gene Therapy For Parkinson’s Shows Efficacy, Safety

 
• By Joseph Haas

Although the data are from a small bridging study, MeiraGTx plans to discuss Phase III options for AAV-GAD in Parkinson’s disease after showing efficacy on a disease rating scale and a quality-of-life measure.

MeiraGTx has high hopes for its Parkinson's disease gene therapy candidate (Shutterstock)

MeiraGTx hopes to take a gene therapy candidate for Parkinson’s disease into Phase III based on positive efficacy and safety data from a small Phase II study that showed significant improvement on a disease rating scale and on a quality-of-life measure. The US/UK biotech reported data from a 14-patient, three-arm, sham-controlled bridging study of AAV-GAD on 15 October and noted that the candidate has been tested in 58 total patients with no drug-related safety concerns.

Key Takeaways
  • MeiraGTx is looking to Phase III planning with the FDA and EMA following Phase II bridging study data showing efficacy on two endpoints and safety...

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