South Korea’s Helixmith said on Thursday it has resumed a Phase 3 clinical trial of its investigational gene therapy Engensis (VM202) for the treatment of critical limb ischemia (CLI) in China after pausing patient enrollment due to the Covid-19 pandemic.
CLI that usually occurs in diabetes patients is an ulcer on or around the foot area that is unresponsive to standard therapies.
Patient recruitment could be completed by the end of next year, it projected, hoping for local market entry in 2023.
Helixmith signed a partnership agreement with Beijing Northland Biotech in 2014 to co-develop the drug for the indication and launched clinical trials at 16 hospitals and research centers across China in July last year. The study is designed to evaluate the efficacy of the gene therapy in the treatment of pain and ulcers.
CLI is estimated to affect reach up to 7.8 million Chinese and the potential value of CLI treatment is projected to surpass 20 trillion won ($17.6 billion) in China alone.
Helixmith shares rose 8 percent to close Thursday at 21,600 won.
By Park Yoon-gyun and Minu Kim
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