Helixmith Co. has chosen PRA Health Sciences as the contract research organization (CRO) for the Phase 3-3 clinical trial of its investigational diabetic peripheral neuropathy (DPN) drug Engensis in the United States, moving a step closer to commercialization of its novel drug.
The South Korean biopharmaceutical company said on Thursday that PRA was chosen based on various evaluation criteria and it will continue its CRO role following the current Phase 3-2 trial.
Helixmith has been preparing for a follow-up trial as two second trials (Phase 3-2, 3-2b) near their finish. As of July 20, a total of 45 subjects were randomized for each study group in the Phase 3-3 study. Helixmith said it has confidence in the ongoing clinical trial management as the subjects have a high level of compliance with trial regulations, while variable differences are low and internal consistency for reliability verification remains high.
Helixmith submitted a Phase 3-3 clinical trial protocol of Engensis to the U.S. Food and Drug Administration in September last year following FDA guidelines for multiple Phase 3 trial results to review commercialization.
The Phase 3-3 trial has a similar design as the Phase 3-2 trial. The primary endpoint is the pain reduction at month 6 and secondary endpoints includes the patient’s recovery of sensory function. A Phase 3-3b trial is also planned to collect safety data.
Its shares were down 1.74 percent at 28,200 won ($24.61) in early afternoon trading on Friday.
By Park Yoon-gyun and Minu Kim
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