China-based dermatology specialist Cutia Therapeutic (HKG: 2487) has revealed a positive readout from its Phase II study for the potential Category 1 drug CU-20401, a recombinant mutant collagenase, in the treatment of subcutaneous fat accumulation, meeting its primary endpoint.
Efficacy and Safety Profiles of CU-20401
The treatment efficacy rates of both the low-dose and high-dose CU-20401 groups were found to be superior to those of the placebo control group, with statistically significant differences. The secondary efficacy endpoint data also demonstrated similar efficacy advantages. Throughout the trial period, no adverse events rated at level ≥ 3 by the Common Terminology Criteria for Adverse Events (CTCAE), no adverse events leading to adjustments in the study drug or withdrawal from the clinical trial, and no serious adverse events (SAEs) occurred in the CU-20401 group, including both low-dose and high-dose cohorts.
Innovative Mechanism of Action for Fat Reduction
CU-20401 features an innovative mechanism of action that selectively targets adipocytes attached to the extracellular matrix of adipose tissue. After local injection, CU-20401 degrades the extracellular matrix collagen in the subcutaneous adipose layer, leading to adipocyte apoptosis and effectively reducing local fat accumulation. CU-20401 catalyzes collagen degradation at a lower rate with mild catalytic activity, thereby reducing the side effects associated with wild-type collagenase, such as bruising and pain.-Fineline Info & Tech
