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Helixmith’s Engensis phase 3 trial yields no meaningful result

Another blow to Korean bio market after SillaJen’s halted Pexa-Vec trials in Aug.

Helixmith shares on Korea’s secondary bourse Kosdaq closed 30 percent lower at 120,000 won ($100) on Tuesday, the deepest dive possible in a day, after the company made an official report to shareholders regarding a bump in the clinical phase 3 trial results of its innovative drug candidate Engensis, Monday.

Helixmith is better known by its 20-year-old name ViroMed. ViroMed was founded in 1999 as a bio venture that develops new and innovative drugs for cardiovascular and neurological diseases. In 2005, it became the first company in Korea to make an initial public offering based on the promise of its technology.

ViroMed changed its name in March to Helixmith, a portmanteau of “helix,” based on the shape of DNA, and “smith,” a crafter.

Helixmith recently completed its first phase 3 study of Engensis versus placebo in 500 subjects with painful diabetic peripheral neuropathy. DPN is nerve damage particular to diabetic patients. 


Diabetic neuropathy (Wikimedia Commons)
Diabetic neuropathy (Wikimedia Commons)


Findings from the phase 3 trial revealed that Egensis DNA was mixed up in some placebo group subjects, while some subjects in the Engensis group showed overly low Engensis DNA concentrations. These unexpected pharmacokinetic results clouded the interpretation of the functions of Engensis, Helixmith said.

Helixmith convened an investors’ meeting at the NH Investment and Securities building in Yeouido, Seoul, in the early morning of Tuesday, where it explained that a fault must have occurred at the hospital administering Engensis for clinical trial.

A sudden increase in the subject number appeared to have compromised the management of the clinical trial, said Kim Sun-young, founder of Helixmith, at the explanation session.

The company said it would share details with the US’ Food and Drug Administration in a meeting scheduled for December.

Helixmith said the safety profile of Engensis remained unchanged, but that the efficacy of the drug was not statistically meaningful. Due to the unexpected pharmacokinetic results, it is impossible to derive accurate conclusions about the efficacy of Engensis as of now, Helixmith said.

The company will set up an investigation team led by Leonard Fish, a clinical expert, to analyze the pharmacokinetic results.

Smaller phase 3 trials are in plans to begin in the next six months, with a new finish estimated for around early 2022.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)
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