Research & Development
Caliway Biopharmaceuticals' CBL-514 receives US FDA Fast Track designation for Dercum's disease
15 February 2024 -

Caliway Biopharmaceuticals, a Taiwan-based, clinical-stage biopharmaceutical company, announced on Wednesday that it has received Fast Track designation from the US Food and Drug Administration (FDA) for the investigation of CBL-514 intended for the treatment of Dercum's disease, a rare disorder that is characterised by the development of painful lipomas primarily located on the trunk region, and the extremities close to the trunk.

The company says that CBL-514, a lipolysis injection, can reduce local subcutaneous fat by selectively inducing adipocyte apoptosis. It is the first drug to receive Fast Track designation for Dercum's disease treatment.

The decision was based on the company's preclinical and CBL-0201DD Phase two (NCT05387733) clinical study results, indicating that CBL-514 is the first and only product to showcase clinically meaningful and statistically significant results in painful lipomas complete clearance or dimensions decrease of over 50%, and significant pain improvement by 4.7 points.

Vivian Ling, Caliway CEO, said, 'We are very pleased to see the FDA's decision on granting Fast Track designation to CBL-514. Dercum's disease is a rare disease characterised by the growth of painful lipomas, the pain can often be chronic and disturbing. With the Fast Track designation, Caliway can benefit from more frequent engagement with the FDA, which will support the collection of appropriate clinical data to accelerate CBL-514 development, and provide the treatment to patients who have been suffering with this disease.