Cutia Therapeutic (HKG: 2487), a China-based dermatology specialist, has announced the successful completion of a Phase I study for its potential Category 1 drug CU-20401, a recombinant mutant collagenase, which is being investigated for the treatment of abdominal fat accumulation. The single-center, open-label, placebo-controlled, dosage-escalation study enrolled 48 subjects in China to assess the safety and tolerability of CU-20401.
The results from the study indicate that CU-20401 demonstrates good overall safety and tolerability, with no significant correlation to dosage. There were no level 3 or higher treatment emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), severe adverse events (SAEs), or TEAEs and TRAEs leading to withdrawal from the trial across any dose group. Moreover, the blood drug concentrations of all subjects were below the lower limit of detection, suggesting extremely low systemic exposure following subcutaneous injection of CU-20401. The clinical trial data also hinted at preliminary efficacy trends, with increasing time correlating with a more significant reduction in subcutaneous fat volume in the abdominal administration area relative to baseline during the three-month follow-up period.
CU-20401’s innovative mechanism of action involves selective targeting of 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 is anticipated to effectively reduce local fat accumulation. The drug’s lower rate of collagen degradation and mild catalytic activity are designed to reduce the side effects associated with wild-type collagenase, such as bruising and pain.
This Phase I study’s successful outcome positions Cutia Therapeutic at the forefront of dermatological innovation, potentially offering a novel treatment option for patients seeking to reduce abdominal fat accumulation.- Flcube.com
