Helixmith's 'Engensis' Begins Domestic Phase 2a Clinical Trial for ALS Treatment

Helixmith logo (Provided by Helixmith)

[Asia Economy Reporter Chunhee Lee] Helixmith's gene therapy drug 'Engensis (VM202)' has officially commenced its domestic Phase 2a clinical trial for amyotrophic lateral sclerosis (ALS, Lou Gehrig's disease).

Helixmith announced on the 10th that the clinical trial team led by Professor Seunghyun Kim of Hanyang University Hospital began the first administration of Engensis to ALS clinical patients on the 9th. This Phase 2a clinical trial is being conducted with a total of 18 participants in the United States and Korea. The company expects that 30-50% of these participants will be enrolled in Korea.

Through this clinical trial, Helixmith aims to secure safety and efficacy data for Engensis and plans to proceed with a Phase 2b clinical trial of a scale sufficient for statistical validation based on the results.

Engensis is a drug composed of plasmid DNA expressing hepatocyte growth factor (HGF) protein. Research and clinical studies have revealed that a simple muscle injection can produce HGF protein in vivo, demonstrating effects such as nerve regeneration, angiogenesis, and prevention of muscle atrophy. It has also been designated as an orphan drug and granted fast track status by the U.S. Food and Drug Administration (FDA).

Sunyoung Kim, CEO of Helixmith, stated, "Engensis represents a new approach to neuromuscular diseases," adding, "We hope to demonstrate the safety and efficacy of Engensis in the Phase 2a ALS clinical trial and provide a new treatment option possibility for ALS patients, who currently have no available therapies."

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