Helixmith’s Plasmid DNA Therapeutic Moves Forward With New Formulation
Non-Viral Gene Therapy Set For Mass Production
South Korea's Helixmith reaches a milestone with a US FDA nod to use a new in-house developed formulation for its plasmid DNA therapeutic Engensis, said to be more suited to mass production, in its upcoming Phase III trials for diabetic peripheral neuropathy.
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Scrip takes a look at the landscape of the South Korean gene and cell therapy sector, which is under the spotlight with the implementation of a new cutting-edge biologics law.
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.
South Korea's drug ministry, together with consumer and business groups, announces a raft of major regulatory innovation tasks it aims to achieve over the next few years, a major goal being to speed up patient access to innovation.