- CBL-514 is the first product to treat cellulite in raised areas.
- Currently, there is no effective and safe treatment for cellulite on the market. The global market for cellulite treatment is estimated to expand to $7.37 billion in 2034.
- The Phase 2 CBL-0201EFP study demonstrated statistically significant efficacy of CBL-514 in reducing cellulite severity scores at 4 and 12 weeks post-treatment.
- More than 50% of participants experienced at least one level of improvement in cellulitis severity 12 weeks after final CBL-514 treatment as assessed by the modified Hexsel Cellulitis Severity Scale between 4 levels of severity.
- CBL-514 is in development for multiple indications, including cellulite, local fat reduction (currently in phase 2b), and Durum disease (currently in Phase 2), which earned Caliway Fast Track and Orphan Drug Designation from the FDA in Feb. 2024.
young TAIPEI CITY, April 25, 2024 /PRNewswire/ — Caliway Biopharmaceuticals (Caliway) today was announced the key results of the Phase 2 study CBL-0201EFP, which met all primary and secondary efficacy endpoints in the ITT (Intent-to-treat) and PP (per-protocol) analysis population, demonstrating the statistically and clinically significant efficacy of CBL- 514 in improving cellulitis severity with favorable safety and tolerability profiles.
CBL-514, Caliway’s lead, is a multi-indication lipolytic injection that can reduce subcutaneous obesity by inducing adipocyte apoptosis. Among all current cellulite treatment products, CBL-514 is the first and only product to treat cellulite in the raised areas.
In addition to treating cellulite, CBL-514 is also in Phase 2 study for the reduction of subcutaneous fat and Dercum’s disease. In addition, the US FDA granted CBL-514 Fast Track and Orphan Drug Designation based on the results of the Phase 2 study CBL-0201DD for Dercum’s disease in February 2024.
CBL-0201EFP Phase 2-Stage 1 Topline Results: Significant Reductions in Cellulite Severity in Three Dose Groups
The Phase 2 CBL-0201EFP study is an open-label study to evaluate the safety, tolerability, and efficacy of CBL-514 injection for the treatment of inflammatory fibrosclerosing pannitis (EFP, cellulitis). Efficacy was assessed using the modified Hexsel Cellulitis Severity Scale (Modified HCSS), with the highest score (9) indicating the most severe severity of cellulitis and the lowest score (0) indicating no cellulitis at all. The severity level of cellulite will be graded as mild (1-3), moderate (4-6) or severe (7-9), which will be determined by the total scores.
In the Phase 2-stage 1 CBL-0201EFP dose-finding study, a total of 12 participants were enrolled in 3 consecutive CBL-514 dose-escalation groups, 40 mg, 60 mg, and 80 mg, to receive 1 CBL-514 treatment administered bilaterally . of the posterior thighs.
Statistical analysis revealed significant reductions in cellulitis severity in three dosage groups. Follow-up assessments 2 and 4 weeks after the single treatment in both thighs showed statistically significant improvements in cellulitis severity for all dose groups, with the high-dose 80 mg group showing the most promising efficacy, reducing the cellulitis severity score (mean ± SD ) of -2.0±0.9 units (p= 0.00049, 95%CI: -2.77, -1.23) and -2.6±1.5 (p= 0, 00169, 95%CI: -3.88, -1.37) at 2 and 4 weeks post-treatment.
Top Line Results of Phase 2-Stage 2 CBL-0201EFP: Over 50% of participants demonstrated at least A Level Improvement between 4 levels of cellulite severity
In the Phase 2-Stage 2 study CBL-0201EFP is a single-arm study, a total of 23 participants were enrolled to receive up to 2 treatments of CBL-514 based on the severity of thigh cellulite, with a maximum single dose not exceeding 320 mg administered at 4 week intervals.
The baseline mean cellulitis severity score of the participants (mean±SD) is 6.5 ± 1.0 points. Four weeks after the final CBL-514 treatment, using a modified HCSS score of 1 ~ 9 in 4 levels of severity, there was a reduction in cellulitis severity with a mean change of -1.3 ± 1.3 points (p < 0.00001, 95% CI : - 1.70, -0.90), demonstrating the statically significant efficacy of CBL-514 in improving cellulite severity at both 4 weeks (p < 0.00001) and 12 weeks (p < 0.00001) after treatment with CBL-514. Additionally, over 50% of participants experienced at least some level of improvement in cellulite severity at 12 weeks after the final CBL-514 treatment.
In addition to the primary efficacy endpoint, a secondary efficacy endpoint assessed by the Global Aesthetic Improvement Scale (GAIS) showed marked improvements in cellulite. After the final treatment, both the Principal Investigator (PI) and participants rated over 95% of subjects as having an improved appearance of cellulite at the four-week point.
The safety and tolerability profiles of CBL-514 demonstrated in both phases of the study were favorable and consistent with previous clinical studies of CBL-514. Most side effects were mild to moderate injection site reactions, including injection site bruising, pain, swelling, and warmth, and resolved within 28 days of treatment.
These findings highlight the potential of CBL-514 as a highly effective treatment option for reducing the severity of cellulite, offering renewed confidence and satisfaction to those affected by this common cosmetic concern.
Caliway will then further develop the cellulite severity scale for future CBL-514 clinical studies to assess cellulite improvement efficacy based on US FDA guidelines.
About Cellulitis (Edema Fibrosclerotic Panangioplasty, EFP)
Cellulite is characterized by the non-pathological dimpled appearance of the skin surface (similar to an orange peel, cottage cheese or mattress appearance), which occurs on the thighs and buttocks. 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. According to the American Society of Plastic Surgeons (ASPS) report, approximately 80 to 90% of women experience cellulite dimples.
Current treatment for cellulite includes non-invasive (medical devices and collagenase medication) and invasive options. However, their effectiveness remains limited and temporary. 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 treatment of cellulite remains unmet. The global market for cellulite treatment is estimated to expand to $7.37 billion in 2034.
About the Phase 2 Study CBL-0201EFP
The Phase 2 study CBL-0201EFP is an open-label study evaluating the efficacy and safety of CBL-514 in participants with edematous fibrosclerotic panniopathy (EFP) cellulitis. The study has an integrated design consisting of a single ascending dose (SAD) arm in Stage 1 followed by a single arm design in Stage 2.
The Phase 1 study (clinicaltrial.gov ID: NCT05632926) included a total of 12 participants enrolled in 3 consecutive escalating CBL-514 dose groups, 40 mg, 60 mg, and 80 mg. Eligible participants will be sequentially assigned to receive 1 cycle of CBL-514 administered by subcutaneous injection on both sides of the posterolateral thighs.
The phase 2 study (clinicaltrial.gov ID: NCT05836779) included a total of 23 participants enrolled in 1 selected dose of CBL-514. Eligible participants will be sequentially assigned to receive up to 2 series of the assigned dose of CBL-514 administered by subcutaneous injection on both sides of the posterolateral thighs.
About CBL-514
CBL-514, a potentially first-in-class small molecule drug, is a lipolytic injection that can induce adipocyte apoptosis and lipolysis to reduce subcutaneous obesity in treatment areas in animal studies without causing systemic CNS and cardiovascular side effects , and respiratory system. Caliway’s preclinical studies showed that CBL-514 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 reduction of subcutaneous fat, Dercum’s disease, cellulite and lipoma treatment.
About Caliway Biopharmaceuticals
Caliway Biopharmaceuticals (Caliway) is a Taiwan-based, clinical-stage biopharmaceutical company driven by the discovery of innovative small molecule therapies with a focus on medical aesthetics and inflammatory diseases.
Listed on the emerging stock exchange in Taiwan (TPEX6919), Caliway aims to become an innovative pharmaceutical leader in aesthetic medicine and other diseases. For more information, visit:
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