Caliway Biopharmaceutical Inc (CBI) has announced that its first pipeline, CBL-514 has demonstrated promising clinical effectiveness and safety in reducing local fat through a mechanism of adipocytes apoptosis.
Current Treatment Options for Fat Reduction
Localized adiposity is often diet and exercise-resistant and may require procedures such as liposuction. Fat-reducing methods are popular because patients desire aesthetically pleasing forms, possibly increased by the pressure exerted by societal and cultural ideals. However, liposuction is expensive, risky and invasive and may not be suitable for all patients.
Some non-invasive procedures include cryolipolysis, high-intensity focused ultrasound (HIFU), low-level laser therapy (LLLT), radiofrequency (RF), injectable products, and high-intensity focused electromagnetic field (HIFEM), but they also have specific safety concerns ,and they are mostly less effective.
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Efficacy and Safety Beyond Comparison
CBL-514 is a minimally invasive, targeted innovation that can tailor to the patient’s shape and subcutaneous fat accumulation area. It is a breakthrough in the non-surgical reduction of large amounts of local fat in terms of its efficacy, safety, and mechanism of action. CBL-514 distinct from the current non-invasive fat-reducing procedures in the market, which are usually only for reducing small amounts of fat.
The phase IIa, open-label, random allocation study of CBL-514 revealed a significant reduction of abdominal fat volume by 24.96% (-119.82 ml) (p<0.00001). CBI stated that only reported minor and injection site-related TEAEs (treatment-related adverse events) and no sequela. Our results show that CBL-514 is safe, well tolerated and effectively reduces abdominal subcutaneous fat.
CBL-514 is an exciting injection alternative that can effectively reduce the subcutaneous fat without causing tissue necrosis or prominent side effects at the injection site. The post-recovery period is short and doesn’t affect the patient’s quality of life.
CBI declared: “ASJ journal has published the results of the CBL-514 phase IIa trial, which is an essential milestone for the company to publish the results of early clinical trials of new drugs in well-known journals. We believe CBL-514 will become a rising star in the Taiwanese pharmaceutical market.”
Forward-thinking Alternative Treatment Choice
According to Ms. Yu Fang Ling, CEO of CBI, also the inventor of CBL-514, it is challenging to reduce local fat through diet, exercise, or medication, particularly resistant fat in the abdomen, thighs, arms, or waist. As a result, it is common to perform a surgical or non-surgical reduction of resistant subcutaneous fat in some areas of the body.
The emergence of CBL-514 may be an alternative treatment option for patients hesitant to receive surgical treatment, making fat reduction more accessible. The treatment and recovery period will be reduced dramatically, and there is no need to purchase or rent expensive equipment.
Promising Market Value
CBL-514 has an estimated market value of $91.1 billion and an estimated 2028 global local market for fat reduction and the sculpture of $65.6 billion.
In addition to aesthetics, CBL-514 also obtained the Phase II IND (Investigational New Drug) clinical trial for Dercum’s disease from the FDA in February, and the study will start in the third quarter of this year. The approval of this IND means that CBL-514 has the potential for multi-indication in both aesthetic and therapeutic markets. According to CBI estimates, the global Dercum’s disease market will rise to $20.3 billion, and the global cellulite market will reach $5.2 billion by 2028.
About Caliway Biopharmaceutical Inc 
Founded in 2012, CBI focuses on breakthrough aesthetics and inflammatory medicine discovery of small-molecule therapeutics to help patients suffering from illness or life-threatening diseases. They focus on areas of unmet medical need and target a growing market worth more than $10 billion to expand their market opportunity. The results of the CBL-514 clinical trial could potentially compete in the more than $100 billion prescription fat reduction market with further advances in the drug development process.
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