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Helixmith Mods Engensis Trial Plans As Probe Unravels PK Anomalies

Pushing Ahead With Phase III Gene Therapy Program

 
• By Jung Won Shin

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.

Gene therapy
Clinical Operation Issues Caused PK Flaws In Helixmith Trial • Source: Shutterstock

Helixmith Co. Ltd., formerly known as ViroMed Co. Ltd., has concluded that flaws in the pharmacokinetic (PK) data from its first US Phase III study with plasmid DNA therapeutic Engensis (donaperminogene seltoplasmid, VM202) for painful diabetic peripheral neuropathy (PDPN) largely stemmed from issues around the specificity of pain index and methods of clinical operation.

As a result, the South Korean venture said the Phase III-1a study failed to reach its primary endpoints, which were change in average pain score from baseline to three-month follow up and at

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