Helixmith Presents Engensis at New York Academy of Sciences Pain Meeting

[Asia Economy Reporter Jang Hyowon] Helixmith announced on the 4th that it attended the Advances in Pain Meeting hosted by the New York Academy of Sciences (NYAS) and presented on Engensis (VM202).

The meeting included co-authors such as Professor John Kessler from Northwestern University Feinberg School of Medicine, Helixmith CEO Sunyoung Kim, and Dr. William Schmidt. Professor Kessler gave the main presentation on Engensis, the world's first gene therapy to conduct a Phase 3 clinical trial for pain.

The New York Academy of Sciences, established in 1817, is a prestigious academic society that promotes innovation in science and technology. The pain meeting brought together researchers from science, clinical, and industry fields involved in neuroscience, especially neurobiology, pharmacology, physiology, genetics/genomics, anesthesiology, and psychology to discuss recent scientific and technological advances and clinical applications in the field of pain.

Professor Kessler detailed the mechanism of action of Engensis and comprehensively summarized clinical results conducted on diabetic peripheral neuropathy (DPN). He emphasized that Engensis consistently demonstrated excellent safety and efficacy, and that patients not using gabapentin-class drugs showed even greater pain reduction effects.

In particular, he highlighted that the pain reduction effect lasted for more than eight months even after the drug was completely eliminated from the body and HGF expression was absent following Engensis injection, suggesting that Engensis has disease-modifying drug (DMD) capabilities as a regenerative medicine that alters disease progression.

Engensis, developed by Helixmith, is a plasmid DNA therapy expressing hepatocyte growth factor (HGF) protein. It targets the root cause of neuropathy not merely by managing pain but through angiogenesis and nerve regeneration effects. 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 pain treatment designated as RMAT in the United States.

The Phase 3-1 trial of Engensis for diabetic peripheral neuropathy (DPN) was selected as a "notable clinical result of Q1 2021" by Nature Biotechnology and ranked among the "Top 10 most downloaded papers of 2021" by the international medical journal CTS (Clinical and Translational Science). Helixmith is currently conducting the follow-up Phase 3-2 clinical trial for DPN in the United States.