In a Phase II trial, the small-molecule drug CBL-514 demonstrated significant reduction in lipoma size and pain improvement in Dercum’s disease, a rare disorder.
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Results from the CBL-514 Phase II study
The CBL-0201DD Phase II study evaluating the first-in-class small-molecule drug CBL-514 for Dercum’s disease, a rare disorder, has demonstrated significant efficacy in reducing lipoma size and complete clearance.
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The study for Dercum’s disease
Evaluated the efficacy and safety of CBL-514 injections in twelve participants. As a primary endpoint, painful lipomas dimension in the high-dose group was reduced by 51.3 percent and 54.7 percent at 4 and 8 weeks after CBL-514 treatments.
Future clinical progression for the first-in-class small-molecule drug
Painful lipomas dimension in the low-dose group was reduced by 40.0 percent and 34.7 percent at 4 and 8 weeks after CBL-514 treatments.
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90.3 percent of painful lipomas in the high-dose group
Showed dimensions reduction after CBL-514 treatments when compared to baseline. In the Dercum’s disease patients who received the high-dose, 64.5 percent of painful lipomas demonstrated complete clearance or dimensions reduction of more than 50 percent after CBL-514 treatments compared to baseline.
- 1. 38.7 percent of painful lipomas in the high-dose group
- 2. The Global Dercum’s Disease Market Research Report
- 3. The global Dercum’s disease treatment market size in 2021 was $11.3 billion
CBL-514 is the first and only product to show clinically meaningful and statistically significant in painful lipomas complete clearance or dimensions reduction of more than 50 percent”— Olivie Rhye, financial analyst
Dercum’s disease treatment
The global Dercum’s disease treatment market size in 2021 was $11.3 billion. With a compound annual growth rate (CAGR) of 6.76 percent, the global market of Dercum’s disease treatment in 2030 is predicted to grow to $19.95 billion.
- Detailed efficacy and safety
- Dercum’s disease CBL-0201DD study
- The Journal of Rare Diseases
- Based on the research findings,
Conclusions
Caliway is currently planning for CBL-0202DD Phase IIb study IND application to further investigate CBL-514.
