2024. 05
Date： 2024.05.12 -
Caliway Completes the Subject Recruitment in CBL-514 Phase 2b Study for Subcutaneous Fat Reduction
New Taipei City, May 12, 2024 – Caliway Biopharmaceuticals (Caliway) announces the subject recruitment in the CBL-0205 Phase 2b study (clinicaltrials.gov ID: NCT06005441) was completed on May 10, 2024. A total of 173 subjects were enrolled in the study.
The CBL-0205 study is a multi-centered, randomized, placebo-controlled Phase 2b study that was planned to enroll 160 subjects to evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing subcutaneous fat.
Currently, there are two CBL-514 Phase 2b studies for subcutaneous fat reduction ongoing in the U.S., Australia, and Canada. To optimize the Phase 3 study protocol, and to enhance the likelihood of meeting study endpoints successfully, both CBL-514 Phase 2b studies were designed to mimic the Phase 3 study by employing the same efficacy assessment tools, Magnetic Resonance Imaging (MRI) and Abdominal Fat Reduction Scale (AFRS), a scale developed as the result of FDA guidance.
The CBL-0205 Phase 2b study is expected to be completed in Q3 2024, and the topline results are anticipated in Q1 2025.
According to the American Society of Plastic Surgeons’ report, more than 60% of people are reluctant to undergo subcutaneous fat reduction procedures due to the fear of the side effects. The medical needs for subcutaneous fat reduction remain unmet. The subcutaneous fat reduction market in 2030 is estimated to be US$89.2 billion, referencing the Deloitte China Aesthetic Medicine Market Outlook Report.
Caliway is investigating multiple indications for CBL-514, including non-invasive subcutaneous fat reduction, Dercum’s disease, and cellulite.
Listed on the emerging stock market in Taiwan (TPEX-6919), Caliway aims to become an innovative pharmaceutical leader in aesthetic medicine.
The CBL-0205 study is a multi-centered, randomized, placebo-controlled Phase 2b study that was planned to enroll 160 subjects to evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing subcutaneous fat.
Currently, there are two CBL-514 Phase 2b studies for subcutaneous fat reduction ongoing in the U.S., Australia, and Canada. To optimize the Phase 3 study protocol, and to enhance the likelihood of meeting study endpoints successfully, both CBL-514 Phase 2b studies were designed to mimic the Phase 3 study by employing the same efficacy assessment tools, Magnetic Resonance Imaging (MRI) and Abdominal Fat Reduction Scale (AFRS), a scale developed as the result of FDA guidance.
The CBL-0205 Phase 2b study is expected to be completed in Q3 2024, and the topline results are anticipated in Q1 2025.
About Subcutaneous Fat Reduction
The current subcutaneous fat reduction procedures include invasive surgery, such as liposuction and abdominoplasty, and non-invasive products. Studies have shown that liposuction can remove an average of 183.3mL of abdomen fat, yet it involves a lengthy procedure that is generally performed in an operating room and may also carry the risk of unfavorable outcomes, such as periumbilical under-correction and permanent skin creases, and other moderate to severe side effects. The efficacy of non-invasive procedures is generally less optimal with limited treatment areas and potential side effects, including tissue necrosis, nerve damage, and paradoxical adipose hyperplasia (PAH).According to the American Society of Plastic Surgeons’ report, more than 60% of people are reluctant to undergo subcutaneous fat reduction procedures due to the fear of the side effects. The medical needs for subcutaneous fat reduction remain unmet. The subcutaneous fat reduction market in 2030 is estimated to be US$89.2 billion, referencing the Deloitte China Aesthetic Medicine Market Outlook Report.
About CBL-514
CBL-514, a potentially first-in-class small-molecule drug, is a lipolysis injection that can induce adipocyte apoptosis and lipolysis to reduce subcutaneous adiposity in treatment areas without causing any systematic side effects on the central nervous system and cardiovascular system, 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 subcutaneous fat reduction, Dercum’s disease, and cellulite.
About Caliway Biopharmaceuticals
Caliway Biopharmaceuticals (Caliway) is a Taiwan-headquartered, clinical-stage biopharmaceutical company driven by the discovery of breakthrough small-molecule therapeutics focusing on medical aesthetics and inflammatory disease.Listed on the emerging stock market in Taiwan (TPEX-6919), Caliway aims to become an innovative pharmaceutical leader in aesthetic medicine.