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Helixmith to announce results of Engensis’ second phase 3 clinical trials next month
By Kan Hyeong-wooPublished : June 28, 2022 - 18:31
Local gene therapy biotech firm Helixmith will announce the results of Engensis’ second phase 3 clinical trials for diabetic peripheral neuropathy next month, officials said Tuesday.
“We were hoping to announce the results of Engensis’ second phase 3 clinical trials today, but the (independent Data Monitoring Committee) has requested additional data,” said Kim Sun-young, CEO of Helixmith, in a press conference.
According to the CEO, the requested documents included Engensis’ safety and efficacy data. The iDMC will soon notify the company to either continue with the clinical trials, revise the size of the clinical trials or stop the clinical process, he said.
In June 2020, Helixmith announced that the US Food and Drug Administration gave the green light for the company to begin the second phase 3 clinical trials for Engensis.
Engensis, also known as VM202, is a regenerative gene medicine developed to treat neuropathic pain. As a plasmid DNA therapy designed to produce two isoforms of Hepatocyte Growth Factor, VM202 is being studied for the treatment of diabetic peripheral neuropathy, diabetic foot ulcers, claudication, coronary artery disease and Lou Gehrig’s disease.
“We were hoping to announce the results of Engensis’ second phase 3 clinical trials today, but the (independent Data Monitoring Committee) has requested additional data,” said Kim Sun-young, CEO of Helixmith, in a press conference.
According to the CEO, the requested documents included Engensis’ safety and efficacy data. The iDMC will soon notify the company to either continue with the clinical trials, revise the size of the clinical trials or stop the clinical process, he said.
In June 2020, Helixmith announced that the US Food and Drug Administration gave the green light for the company to begin the second phase 3 clinical trials for Engensis.
Engensis, also known as VM202, is a regenerative gene medicine developed to treat neuropathic pain. As a plasmid DNA therapy designed to produce two isoforms of Hepatocyte Growth Factor, VM202 is being studied for the treatment of diabetic peripheral neuropathy, diabetic foot ulcers, claudication, coronary artery disease and Lou Gehrig’s disease.
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