Helixmith's core pipeline, 'Engensis (VM202),' failed to meet the primary endpoint in its Phase 3 clinical trial.
Helixmith announced on the 3rd that the analysis of the top-line data from the Phase 3-2 and 3-2b clinical trials of Engensis targeting diabetic peripheral neuropathy (DPN) conducted in the United States failed to achieve the primary endpoint.
This clinical trial compared the average daily pain score (ADPS) over the past week at 6 months (180 days) and 12 months (365 days) after the first dose between the Engensis group and the placebo group. The Phase 3-2 trial involved 162 patients, and the Phase 3-2b trial was conducted on 106 patients who agreed to participate in the extension study.
However, in this trial, patients who received Engensis did not demonstrate a statistically significant reduction in average pain compared to those who received the placebo. The company stated, "Further analyses on secondary endpoints, exploratory endpoints, and subgroups will continue."
Currently, Engensis is also undergoing clinical trials for diabetic foot ulcers, another diabetic complication, and the company plans to prioritize development in this area. A Phase 3 clinical trial for critical limb ischemia (CLI), a severe form of diabetic foot ulcer, is underway through its Chinese partner, Northland Biotech. The clinical results are expected to be announced within this year.
Sunyoung Kim, founder and Chief Strategy Officer (CSO) of Helixmith, said, "We are deeply disappointed to receive such results in the disease area that was the most advanced. Once the Phase 3 results for the second target disease, diabetic foot ulcers, are available, we will compile all clinical results and report them to the new management team, which will determine the development direction and investment priorities for Engensis."
Jiwook Jung, Vice President of Biosolution, which recently became Helixmith's largest shareholder through a third-party allotment capital increase, stated, "The success of the Engensis DPN clinical trial was not a consideration in Biosolution's investment in Helixmith. The primary purpose of the investment is to utilize the know-how and intellectual property accumulated by Helixmith through various projects as a platform." He added, "With this result, the fixed image of ‘Helixmith = Engensis DPN’ has disappeared, removing uncertainties about the company. We believe that the improved financial structure provides an opportunity to expand and develop other businesses."
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