Cutia Therapeutics announce that the Phase II clinical trial of CU-20401 (recombinant mutant collagenase), a potential Class I new drug of the Group, for submental adipose accumulation has completed last patient enrollment. CU-20401 is a recombinant mutant collagenase that targets obesity, overweight, or other localized adipose accumulation associated metabolic diseases. CU-20401 adopts an alternative mechanism of action where it acts as a collagenase to selectively acts on the extracellular matrix attached to adipose tissue.

After localized injection, CU-20401 degrades extracellular matrix collagen in the subcutaneous fat layer which leads to apoptosis of adipocytes and is expected to effectively reduce localized adipose accumulation. CU-20401 is technologically modified with reduced rate to catalyze the collagen degradation with mild catalytic activity, thus reducing the adverse effects of wild-type collagenase, such as bruising and pain. The Phase II clinical trial of CU-20401 for submental adipose accumulation conducted in China is a multi-center, randomized, double-blind and placebo-controlled trial to evaluate the efficacy and safety of CU-20401.