Caliway Announces the Completion of Subject Recruitment in the CBL-0201EFP Phase 2-stage 2 Study Evaluating the CBL-514 in Cellulite Treatment
The CBL-0201EFP Phase 2-stage 2 study is an open-label trial that will evaluate the efficacy, safety, and tolerability of CBL-514 in treating subjects with moderate to severe cellulite. The study actually enrolled a total of 23 subjects, all of whom will receive CBL-514 treatment. The efficacy and safety will be evaluated at follow-up visits at week 4 and week 12 after the last treatment. The topline results of the study are anticipated in Q2 2024.
About Cellulite (Edematous Fibrosclerotic Panniculopathy, EFP)Cellulite is characterized by the nonpathological appearance of the dimpled skin surface (likened to orange peel, cottage cheese, or mattress appearance), which occurs on the thighs and buttocks. As many as 80 to 90% of women experience cellulite dimpling. The relief alterations of cellulite include depressions and raised areas. The depressions are caused by skin retraction by subcutaneous fibrous septa, while raised areas are projections of fat and subcutaneous structures to the skin surface.
The current treatment for cellulite includes non-invasive (medical devices and collagenase drug) and invasive options. However, their efficacy remains limited as the current treatment options can only treat cellulite temporarily. Additionally, most products would cause significant side effects after administration, including severe bruising, pain, and hyperpigmentation, making most patients reluctant to receive them. The clinical need for cellulite treatment remains unmet. The global cellulite treatment market size in 2022 was $3.3 billion. With a compound annual growth rate (CAGR) of 7.8%, the global market for cellulite treatment is estimated to expand to $5.2 billion in 2028.
About the CBL-0201EFP Phase 2 StudyThe CBL-0201EFP study is a two-stage Phase 2 trial evaluating the efficacy, safety, and tolerability of CBL-514 in treating subjects with cellulite. CBL-514 will be administrated by subcutaneous injection at the treatment area of cellulite on both sides of the posterolateral thighs.
The CBL-0201EFP Phase 2-stage 2 study (NCT05836779) is an open-label trial that will evaluate the efficacy, safety, and tolerability of CBL-514 with up to two treatments, larger treated areas, and higher total doses, compared to the stage 1. All the subjects will receive CBL-514 treatment, and the treatment dose will be based on the PI's evaluation of the cellulite severity. Subjects will receive up to 320 mg of CBL-514 per treatment session at intervals of approximately four weeks. After the last treatment, the efficacy and safety will be evaluated at follow-up visits at V4(Week 4) and V5 (Week 12).
About CBL-514CBL-514, a first-in-class small-molecule drug, is an injection lipolysis drug that can induce adipocytes apoptosis and lipolysis to reduce subcutaneous adiposity in treatment areas in animal studies without causing any systematic side effects on the central nervous system, cardiovascular system, and respiratory system. Caliway’s nonclinical studies showed that CBL-514 inhibits the cell survival kinase DYRK1b, upregulates the apoptosis mediators caspase 3 and Bax/Bcl-2 ratio, and then induces dose-dependent adipocyte apoptosis in vivo and in vitro.
Caliway is investigating multiple indications for CBL-514, including non-invasive fat reduction (reducing subcutaneous fat), Dercum’s disease, cellulite, and lipoma treatment.