2023. 07

Caliway Receives IND approval from the U.S. FDA for the CBL-0205 Phase 2b Study Evaluating CBL-514 in Abdominal Subcutaneous Fat Reduction

New Taipei City, July 31, 2023 - Caliway Biopharmaceuticals (Caliway) today announces that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational New Drug (IND) application for CBL-514 injection’s CBL-0205 Phase 2b Study.
CBL-0205 is a multi-country, multicenter, randomized, placebo-controlled, Phase 2b study. A total of 160 subjects with moderate to severe abdominal fat assessed by the Abdominal Fat Rating Scale (AFRS) will be enrolled in the U.S. and Canada clinical sites in Q4 2023.
The U.S. FDA approved CBL-514’s other Phase 2b study, CBL-0204, for abdominal subcutaneous fat reduction on January 29, 2023. The subject recruitment was initiated on May 31, 2023. The study will enroll 100 subjects with mild, moderate, or severe abdominal fat assessed by AFRS. The patient-reported AFRS in CBL-0204 Phase 2b will be evaluated by photography, while the patient-reported AFRS in CBL-0205 Phase 2b will be self-evaluation using a mirror.

About Fat Reduction

The current methods for fat reduction include non-invasive products and invasive surgery, such as liposuction and abdominal plastic surgery. The efficacy of non-invasive products on the market is generally poor and often takes more than twelve weeks to observe with the limited treating body area. The potential moderate to severe side effects of non-invasive products include tissue necrosis, nerve damage, scar tissue fibrosis, and paradoxical adipose hyperplasia (PAH).
Though the efficacy of surgery is more significant compared to approved non-surgery fat reduction products, the surgery still comes with severe side effects and risks of anesthesia, bruising, infection, and death.
According to the American Society of Plastic Surgeons’ report, more than 60% of people are reluctant to undergo local fat reduction due to the fear of the side effects. The medical needs for local fat reduction remain unmet.

About CBL-514

CBL-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 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.

About Caliway Biopharmaceuticals

Caliway Biopharmaceuticals (Caliway) is a Taiwan-headquartered, clinical-stage biopharmaceutical company driven to breakthrough drug discovery of novel small-molecule therapeutics. Listed on the emerging stock market in Taiwan (TPEX6919), Caliway aims to become an innovative pharmaceutical leader in aesthetic medicine and inflammatory disease. 


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