China-based dermatology specialist Cutia Therapeutics (HKG: 2487) has announced the last subject out (LSO) in a Phase I study for its potential Category 1 drug, CU-20401. This recombinant mutant collagenase is being developed for the treatment of obesity and other metabolic diseases related to local fat accumulation, marking a significant step in the clinical development of a novel therapeutic approach.
Phase I Study Design and Objectives
The single-center, open-label, placebo-controlled, dosage-escalation Phase I study conducted in China is designed to rigorously assess the safety and tolerability of CU-20401 in treating abdominal fat accumulation. This study is crucial in establishing the drug’s profile as it moves through the clinical development pipeline.
Innovative Mechanism of CU-20401
CU-20401 boasts an innovative mechanism of action that selectively targets adipocytes attached to the extracellular matrix of adipose tissue. Following local injection, CU-20401 degrades the extracellular matrix collagen in the subcutaneous adipose layer, leading to adipocyte apoptosis and effectively reducing local fat accumulation. The drug’s design to catalyze collagen degradation at a lower rate with mild catalytic activity is intended to minimize side effects commonly associated with wild-type collagenase, such as bruising and pain.-Fineline Info & Tech
