The board of directors of Cutia Therapeutics announced that the Group has completed a Phase I clinical trial of CU-20401 (recombinant mutant collagenase), a potential Class I new drug, for abdominal adipose accumulation. A total of 48 patients received CU-20401 treatment for abdominal adipose accumulation in this Phase I clinical trial in China. This clinical trial was a single-center, open label, placebo-controlled and dose escalation trial to evaluate the safety and tolerability of CU-20401.

Data from the clinical trial demonstrated an overall favorable safety and tolerability profile for CU-20401, with no significant dose-related effects. There were no Grade 3 or above treatment-emergent adverse events ("TEAE") and treatment-related adverse events ("TRAE"), serious adverse events (SAE), or TEAEs and TRAEs leading to withdrawal from the clinical trial in all dosage groups. In addition, plasma drug concentration in all enrolled patients were below the lower limit of detection, indicating the systemic exposure after subcutaneous injection of CU-20401 was extremely low.

Data from the clinical trial also showed preliminary efficacy trends. The reduction of subcutaneous fat volume relative to baseline was more pronounced in the abdominal treatment area of the enrolled patients during the three-month follow up period as duration prolonged. 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 act 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.