TAIPEI, September 18, 2023 /PRNewswire/ — Caliway Biopharmaceuticals (Caliway), a biopharmaceutical company focused on innovative medical aesthetics and inflammatory medicine discovery of small molecule therapeutics, announced the completion of subject recruitment in the Phase 2 study of CBL-0201EFP.
The Phase 2 study CBL-0201EFP is an open-label trial that will evaluate the efficacy, safety and tolerability of CBL-514 in the treatment of subjects with moderate to severe cellulite. In fact, the study enrolled a total of 23 people, who will receive CBL-514 treatment. Efficacy and safety will be assessed at follow-up visits at week 4 and week 12 after the last treatment. The main results of the study are expected in the second quarter of 2024.
About Cellulitis (Edema Fibrosclerotic Panangioplasty, EFP)
Cellulite is characterized by the non-pathological appearance of a dimpled skin surface (likened to an orange peel, cottage cheese or mattress appearance), which occurs on the thighs and buttocks. 80 to 90% of women experience cellulite dimples. The relief lesions of cellulite include depressions and raised areas. Depressions are caused by contraction of the skin by subcutaneous fibrous septa, while raised areas are projections of fat and subcutaneous structures on the surface of the skin.
Current treatment for cellulite includes non-invasive (medical devices and collagenase medication) and invasive options. However, their effectiveness remains limited as current treatment options can only treat cellulite temporarily. In addition, most products would cause significant side effects after administration, including severe ecchymosis, pain, and hyperpigmentation, making most patients reluctant to take them. The clinical need for the treatment of cellulite remains unmet. The size of the global cellulite treatment market in 2022 was 3.3 billion dollars. At a compound annual growth rate (CAGR) of 7.8%, the global cellulite treatment market is estimated to expand to 5.2 billion dollars in 2028.
About the Phase 2 Study CBL-0201EFP
Study CBL-0201EFP is a two-stage Phase 2 trial evaluating the efficacy, safety and tolerability of CBL-514 in the treatment of people with cellulite. CBL-514 will be administered by subcutaneous injection into the cellulite treatment area on both sides of the posterior thighs.
The Phase 2 CBL-0201EFP 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 with stage 1. All subjects will be treated with CBL-514 and the dose of treatment will be based on the PI’s assessment of cellulitis severity. Subjects will receive up to 320 mg of CBL-514 per treatment session at approximately four-week intervals. After the last treatment, efficacy and safety will be assessed at follow-up visits at V4 (Week 4) and V5 (Week 12).
About CBL-514
CBL-514, a first-in-class small molecule drug, is an injectable lipolytic drug that can induce adipocyte apoptosis and lipolysis to reduce subcutaneous obesity in treatment areas in animal studies without causing systemic side effects in 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 (subcutaneous fat reduction), Dercum’s disease, cellulite and lipoma treatment.
About Caliway Biopharmaceuticals
Caliway Biopharmaceuticals (Caliway), is a Taiwan-Clinical-stage biopharmaceutical company driven to pioneer drug discovery of new small molecule therapeutics to help patients suffering from disease or life-threatening diseases. At Caliway, we aim to be an innovative pharmaceutical leader in medical aesthetics and inflammatory diseases. For more information, visit: www.Caliway.com.tw/en
SOURCE Caliway Biopharmaceuticals
