South Korean biotechnology company Helixmith hit the price ceiling on Oct. 7 as the company announced results demonstrating the long-term safety and efficacy of its flagship DNA plasmid gene therapy VM202 for diabetic peripheral neuropathy patients in a phase 3-1b extension study earlier the same day.
From around 9:10 a.m., Helixmith‘s share price came to 93,200 won ($77.90), up 30 percent from the previous day’s close. This led to a sharp upshoot in its market cap to 2 trillion won – making it the seventh largest on Korea’s secondary bourse Kosdaq.
In a disclosure prior to the trading session, Helixmith said VM202 for DPN patients, also known as Engensis, met the primary and secondary endpoints -- safety and efficacy at 12 months, respectively -- in a phase 3 extension study conducted in the US since January.
“We are very glad to see the data that continues to confirm the promise of VM202. The 12 months of safety and efficacy data will be particularly important to our regulatory package. We will work on designing our next phase 3 and include a robust management plan to confirm the good data we see today,” said Helixmith CEO and founder Kim Sun-young.
“It is a pleasant surprise that DPN 3-1b shows statistically significant efficacy with a relatively small sample size. This indicates that we can potentially design our future phase 3 trials with only 100-150 subjects and still be powered to show significance,” said Dr. William Schmidt, head of clinical development of Helixmith.
The Helixmith share price has been on a roller-coaster ride over the past few weeks. In late September Helixmith share price took a nose-dive due to a data mix-up in a separate phase 3-1a trial for Engensis. Since Sept. 24, the Helixmith share price hit the price floor for two consecutive trading days, falling 30 percent, respectively.
Headquartered in Seoul National University, Helixmith was founded in 1996. Formerly known as ViroMed, the company is undergoing various stages of clinical trials for DNA-based drug pipelines to address unmet medical needs for cardiovascular and neurological diseases.
By Son Ji-hyoung (firstname.lastname@example.org)