Caliway Biopharmaceuticals (Caliway) announced that the United States Food and Drug Administration (U.S. FDA) has accepted the CBL-514 Investigational New Drug (IND) application of CBL-0202 DD Phase 2 Study to treat Dercum's Disease. Dercum's disease is a rare disease characterized by the growth of painful lipomas. The pain can be severe, chronic (> 3 months) and often disabling.

So far, no approved treatment for Dercum's disease has led to the 2032 global treatment market expansion to 22.75 billion. Previous CBL-514 Phase 2 study (CBL-0201DD, NCT05387733) has demonstrated its efficacy in lipoma dimension reduction by more than 50% and significant pain improvement by 4.7 points, showing its potential in becoming the first approved treatment for Dercum's disease. The CBL-0202DD Phase 2 study will further evaluate the efficacy, safety, and tolerance of CBL-514 in treating Dercum's disease compared with placebo.

The subject recruitment will be initiated in second quarter 2024.