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Helixmith’s Plasmid DNA Therapeutic Moves Forward With New Formulation

Non-Viral Gene Therapy Set For Mass Production

 
• By Jung Won Shin

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.

DNA
DPN Phase III-2 Results Pivotal For Program Success • Source: Alamy

Helixmith Co., Ltd. is set to use a new formulation of Engensis (VM202) for an upcoming Phase III trial for diabetic peripheral neuropathy (DPN), a move that may bring the company closer to commercialization of the plasmid DNA therapeutic, its lead pipeline asset. The Korean bioventure said the US Food and Drug Administration had no comments or objections to the planned use of the new formulation, developed in-house, in future clinical studies.

The company expects this will also help its efforts to out-license the asset and attract additional investment.

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