Helixmith said Friday that the clinical trial phase 3-1 result of Engensis (VM202), its gene therapy for diabetic peripheral neuropathy (DPN), failed to reach the goal with the first evaluation index, but that there was no mixing of drugs.
The biopharmaceutical company failed to conclude because the clinical trial data of Engensis (VM202) was contaminated. Helixmith said there was a possibility of a drug mix between the drug and placebo. It then analyzed 500 patients who took part in the clinical trial phase 3-1 clinical and said that there was no abnormality in the pharmacokinetics.
"As a result, we found there was no 'statistical significance' compared to placebo in three months," it said.
There were rumors last year speculating about the reasons for the clinical trial failure, such as the intentional or mistaken switch of labels and managers’ inability to recognize such confusion beforehand. “All these rumors have proved groundless,” the company said in a press release.
According to Helixmith, the specificity of the pain index and problems with a particular method of clinical operation seems to have caused the failure. In the clinical trial phase 3-1B supplemented with 101 patients, however, Helixmith succeeded in achieving the goal in both the main evaluation index (safety) and the sub-evaluation index (effectiveness).
"Safety was not significantly different in the frequency and extent of adverse events between Engensis and placebo, and we could not find adverse effects or serious adverse events related to Engensis," Helixmith said.
In this study, the statistical significance was visible in the third, sixth, and 12th month and the differences in the pain reduction effect between Engensis group and placebo group were 1.1, 0.9, 0.9, respectively, in the sixth, ninth and 12th month, with the probability value smaller than 0.01 or 0.05.
Helixmith said it has carefully analyzed the data from the two clinical trials to determine the cause of such contradicting results. The company plans to introduce devices that minimize or eliminate this phenomenon in following clinical trials phase 3, it added.
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