Helixmith said Thursday that it has been informed of the recommendation by the Independent Data Monitoring Committee (IDMC) following the panel’s interim analysis of its diabetic peripheral neuropathy (DPN) treatment, Engensis (VM202).

The IDMC reviewed the interim analysis data and the results of Helixmith's inspection of data on 76 patients, 50 percent of 152 patients.

As a result, the committee confirmed that the registration for these patients is near completion. In addition, the IDMC’s analysis of the Data Safety Monitoring Commission (DSMB) report showed no difference in the adverse effects between groups, proving VM2020 is safe, according to the Korean company.

In conclusion, the IDMC recommended that additional interim analysis be conducted on pre-registered patients to determine whether to proceed with the clinical trial, Helixmith said.

Accepting the IDMC's recommendation, Helixmith plans to continue recruiting clinical subjects and complete the registration of all 152 patients, the minimum size to decide whether to proceed with additional interim analysis in consultation with the IDMC, the company added.

"More than 95 percent of the 152 patients subject to the minimum clinical trial have already been registered,” said Park Young-joo, Helixmith’s head of the clinical development division. “However, since subjects who have already expressed consent and are being screened will have to participate in the clinical trial, the final enrollment is expected to be around 160 people.”

Park added that the company would soon complete the recruitment by setting a date for submitting the Informed Consent Form.