Taiwan-based Caliway Biopharmaceuticals, a specialist in medical aesthetics and inflammatory medicine, has announced that its trial assessing the efficacy and safety of CBL-514 in subjects with Dercum’s Disease lipomas has met all primary and secondary efficacy endpoints. CBL-514 is a first-in-class small-molecule injection lipolysis drug designed to induce adipocyte apoptosis and lipolysis, reducing subcutaneous adiposity without causing systematic side effects on the central nervous, cardiovascular, or respiratory systems. The Phase II trial, known as CBL-0201DD (NCT05387733), also demonstrated good safety and tolerance profiles.
Understanding Dercum’s Disease and Its Impact
Dercum’s disease is a rare and recurring disorder characterized by the development of painful lipomas, primarily on the trunk region and extremities close to the trunk. The chronic pain is often disabling, symmetrical, and resistant to traditional analgesics. The disease’s main symptoms include obesity, painful adipose tissue, and numerous psychiatric manifestations such as sleep disturbances, depression, and anxiety. The etiology of Dercum’s disease remains unknown, and there are currently no treatment options available.
CBL-0201DD Phase II Study Results
In the CBL-0201DD Phase II study, 12 participants with at least four painful and well-defined lipomas were recruited and randomized into two dose groups of CBL-514, with six participants per group. In the high-dose group, the dimension of painful lipomas was reduced by 51.3% (p<0.0001) and 54.7% (p<0.0001) at 4 and 8 weeks after CBL-514 treatments, respectively. In the low-dose group, the reduction was 40.0% (p=0.0002) and 34.7% (p<0.0001) at 4 and 8 weeks post-treatment. The results in the low-dose group showed statistical significance in primary and all secondary endpoints, with improvements also achieved in secondary efficacy endpoints.-Fineline Info & Tech
