Helixmith's 'Enzensus' Clinical Paper Included in Top 10 Downloads of International Medical Journal

[Asia Economy Reporter Lee Gwan-joo] Helixmith announced on the 14th that the results of the Phase 3-1 clinical trial of the gene therapy drug Engensis (VM202) for diabetic peripheral neuropathy (DPN) ranked among the top 10 most downloaded papers last year in the international medical journal 'CTS (Clinical and Translational Science)'.

The paper from Helixmith was led by John Kessler, Professor of Neurology at Northwestern University in the United States. The researchers reported that Engensis (VM202) demonstrated high safety throughout the Phase 3-1 trial for DPN, and showed excellent efficacy in the extension trial, Phase 3-1b.

They particularly noted that the effect of Engensis (VM202) lasted for 8 months after injection, and that the analgesic effect was even more pronounced in patients who did not take gabapentin-class drugs, which are the most commonly used medications for DPN patients. The researchers emphasized the potential of Engensis (VM202) as a regenerative medicine drug capable of fundamentally treating DPN. In conclusion, the researchers expressed high expectations for Engensis (VM202) as a next-generation therapy in the field of DPN, where unmet medical needs are very significant.

Alethea Gerding, editor of CTS, said, “The Helixmith Engensis DPN Phase 3 clinical trial paper has been downloaded over 3,000 times, indicating widespread global interest among readers,” adding, “Helixmith’s paper clearly demonstrates the value of translational science.” The paper was also selected as one of the ‘Notable Clinical Trial Results 1Q21’ by Nature Biotechnology in May last year.

Sunyoung Kim, CEO of Helixmith, said, “I am pleased to hear that the paper reporting Helixmith’s DPN Phase 3-1 data is receiving significant attention from industry, medical, and academic circles,” and added, “The DPN Phase 3-2 trial is progressing smoothly despite the COVID-19 pandemic, and we expect to obtain topline data by the end of this year.”

Helixmith’s Engensis (VM202) is a plasmid DNA-based gene therapy that targets the root cause of neuropathy through angiogenesis and nerve regeneration effects, rather than merely managing pain. The U.S. FDA recognized the scientific and clinical results of Engensis and designated it as a Regenerative Medicine Advanced Therapy (RMAT) in 2018. It is the first gene therapy to receive RMAT designation among common diseases affecting over one million patients.

This content was produced with the assistance of AI translation services.