Helixmith’s botched trial gets a second chanceHelixmith said its gene therapy for diabetic peripheral neuropathy proved effective in a clinical trial in the United States, and investors rallied behind its stock.
The company, formerly known as ViroMed, announced in a regulatory filing Monday that VM202-DPN proved its safety and efficacy according to data from a U.S. Phase 3 extension study. The trial was an extension of the original 500-subject initial stage of a Phase 3 clinical trial that failed because the placebo and the drug being tested were mixed up: Some people in the control group received the treatment while some in the experimental group were given the placebo.
The extension study, which kicked off in January, enrolled 101 subjects from the original 500 subjects. It showed that 12 months after initial injections, patients who were injected with VM202-DPN showed lower signs of adverse effects than the placebo group.
Helixmith said the gene therapy for diabetic peripheral neuropathy demonstrated “statistically significant pain reductions” compared to the placebo group. The difference in pain reduction was greater when compared to those who didn’t receive any medication, even the placebo.
The company added that the extension study also showed signs that VM202-DPN has nerve-regenerating properties.
After news of the results of the extension study was released, Helixmith’s shares skyrocketed Monday to hit the daily limit of 30 percent to 93,200 won ($77.87). The company’s shares previously hit a low of 64,400 won a few days after it released the disappointing results of the initial U.S. Phase 3 clinical trial.
Yet questions remain whether the data from the additional study is truly statistically useful. The extension study’s subject size was significantly smaller than that of the initial Phase 3 clinical trial and only 12 test sites out of original 25 took part in the study.
Helixmith is expected to present the results of both Phase 3 studies to the U.S. Food and Drug Administration in a meeting scheduled for December.
BY KO JUN-TAE [firstname.lastname@example.org]