CUTIA-B (02487) announced that the group has completed the Phase II clinical trial (the clinical trial) of the potential Class 1 new drug CU-20401 (recombinant mutant collagenase) conducted in China for the treatment of submental fat accumulation. This clinical trial shows that CU-20401 demonstrates significant and robust therapeutic advantages with good safety.
The clinical trial is a multicenter, randomized, double-blind, and placebo-controlled trial aimed at evaluating the efficacy and safety of CU-20401 in patients with moderate to severe submental fat accumulation. A total of 108 subjects were enrolled in the trial and randomly assigned to three groups in a 1:1:1 ratio, namely the low-dose group of CU-20401 (low-dose group), the high-dose group of CU-20401 (high-dose group), and the placebo control group (placebo group). All groups received a single dose, with a medication adherence rate of 100% among the subjects.