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Helixmith Facing Engensis Challenges After Disappointing First Phase III Data

 
• By Jung Won Shin

Helixmith delays making conclusions on disappointing first top-line data from lead US Phase III study of plasmid DNA therapeutic Engensis, citing unexpected pharmacokinetic results in the placebo and treatment groups. The South Korean biotech vows to improve strategy for upcoming trials, but much may hinge on their success.

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Helixmith Eyes Strategies For Engensis Trial Success • Source: Shutterstock

Helixmith has found serious flaws in pharmacokinetic data from the first Phase III trial with its lead product Engensis (VM202) and has delayed making conclusions based on what were the first top-line results from a US study.

During a review of the recently completed Phase III study of Engensis versus placebo in 500 patients with painful diabetic peripheral neuropathy (PDPN), the South Korean venture discovered that Engensis DNA was also found in some placebo group subjects

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