Helixmith Mods Engensis Trial Plans As Probe Unravels PK Anomalies
Pushing Ahead With Phase III Gene Therapy Program
Executive Summary
After probing pharmacokinetic data flaws in the first US Phase III study for its gene therapy Engensis, Korea's Helixmith concludes that these stemmed from clinical operation issues. As a result, it admits a failure to meet the primary endpoint but is still moving forward with new trials given signals of efficacy and safety in an extended study.
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