Helixmith has decided to postpone announcing the interim results of the U.S. phase 3 clinical trial for diabetic peripheral neuropathy (DPN) using its new gene therapy, Engensis (VM202), until next month, its top manager said.

Helixmith CEO Kim Sun-young speaks at a media event regarding its diabetic peripheral neuropathy treatment, Engensis, at the company headquarters in Seoul Tuesday.
Helixmith CEO Kim Sun-young speaks at a media event regarding its diabetic peripheral neuropathy treatment, Engensis, at the company headquarters in Seoul Tuesday.

The company had planned to share the results of the Independent Data Monitoring Committee (iDMC) 's recommendation, which was going to be one of the following outcomes -- clinical continuation, clinical scale revision, and clinical suspension – at the news conference on Tuesday.

However, the company had to postpone the announcement as the iDMC requested additional data before making a decision.

According to industry insiders, the iDMC interim results measure the success of the phase 3 clinical trial. However, despite the iDMC’s postponement of making a decision, Helixmith CEO Kim Sun-young stressed that requesting additional data from the iDMC does not mean that the company's trial has failed.

"It is not unusual for the iDMC to request additional data as it requests such data from time to time," Kim said. "The additional data requested is for general safety and efficacy data frequently discussed during the data analysis process and did not mean that there's a problem."

He added that the company is discussing with the iDMC to receive interim results in July.

Kim noted that patient registration for Engensis' phase 3 clinical registrations exceeded 100 in mid-March and has since risen to 134.

"Helixmith expects to meet the target number by early- to mid-August as the registration speed is getting faster amid the slowdown of the Covid-19," Kim said. "If we complete clinical patient registration by August, we will announce the top-line result next January or February."

Kim added that the goal is to announce it before the regular general meeting of shareholders early next year.

Kim explained that commercialization had already begun. "We decided we should prepare for the market based on phase 2 and phase 3 consistency and excellent efficacy," Kim said. "We are looking for a commercialization partner."

Helixmith has communicated with multinational pharmaceutical companies for a long time to build various partnerships, such as technology transfer, Kim added.

During the news conference, CEO Kim also outlined the company's goal to make a quantum leap in 2022 and 2023 through technology transfer of candidate materials, including Engensis and bio platform business.

"I think Engensis has great competitiveness because there are currently no similar products, and it will remain so in the next decade," Kim said. "Through this, we believe that technology transfer will be possible, and seek financial benefits by finding partnerships this year or next."

Kim stressed that the company also owns many new candidates as good as or better than Engensis.

"By raising the value of these candidate substances or boldly transferring technology, we will raise the material value and company value through various methods," Kim said.

However, the stock market reacted negatively to the iDMC’s postponement of announcing its result. As of 3:00 p.m. Tuesday, the company’s shares stood at 22,750 won ($17.70), down 12.33 percent from the previous trading day.

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