Caliway's CBL-514 Phase 2 Study Receives Recognition in Aesthetic Surgery Journal
Caliway's Notable Achievement in Fat Reduction Research
Caliway Biopharmaceuticals has recently celebrated a significant milestone with the acceptance of its CBL-514 Phase 2 study, also known as CBL-0202, for publication in the prestigious Aesthetic Surgery Journal (ASJ), a leader in the field of aesthetic medicine. This achievement is a considerable step forward in validating the safety and efficiency of CBL-514, a novel injectable treatment for localized fat reduction.
This groundbreaking study demonstrated that over 60% of participants treated with CBL-514 experienced a reduction of at least 200 mL of subcutaneous fat within just eight weeks. These results are remarkable when compared to the placebo group, which reported no fat reduction, affirming the treatment's effectiveness at a statistically significant level (p < 0.0001). Notably, 42.9% of participants could achieve at least a 150 mL reduction after only one treatment, showcasing the rapid efficacy of this non-invasive approach.
Caliway's innovative treatment is positioned as a competitive alternative to traditional liposuction, which typically removes an average of 183 mL of fat. The study findings indicate that CBL-514 may surpass conventional methods not only in efficacy but also in safety, owing to its favorable safety profile, which recorded no severe adverse events. Participants reported that the treatment had minimal downtime, allowing for an easier recovery compared to surgical options.
The results were co-authored by Caliway's R&D team and notable figures in the field including Dr. Michael Gold, Dr. Joel Schlessinger, Dr. Steven Dayan, and Dr. Greg Goodman. Alongside them, Caliway’s CEO and Chief R&D Officer, Vivian Ling, played a pivotal role in this research, contributing first-hand to the study.
In addition to its publication, Caliway is gearing up for two major Phase 3 studies set to improve localized fat reduction, slated to kick off in the third quarter of 2025. The company's objective is to pioneer the world's first FDA-approved injectable therapy for larger treatment areas, catering to the increasing global demand for effective non-invasive fat reduction solutions.
Caliway operates under strict adherence to the U.S. FDA's guidelines, ensuring the integrity of its research by consistently utilizing comprehensive data analyses including the complete Intent-to-Treat (ITT) population. This method underscores Caliway's commitment to transparency and credibility in clinical research.
The Aesthetic Surgery Journal, which published the study, is an esteemed peer-reviewed journal that focuses on advancements in aesthetic surgery, serving as a platform for innovators in the field. As Caliway's publications attract more recognition, the company aims to fortify its academic and commercial presence in the global aesthetics market.
In Vivian Ling's words, "The acceptance of our clinical data in ASJ reaffirms our commitment to excellence in research and the potential of CBL-514 in revolutionizing localized fat reduction therapies. We look forward to sharing more results from our forthcoming studies to reinforce our role as a leader in aesthetic medicine."
With the increasing interest in non-surgical procedures, Caliway is set on a path of rapid growth and expansion. The company's plans include enhancing partnerships worldwide while actively recruiting participants for the upcoming pivotal studies. As they move forward, Caliway is determined to introduce innovations that could reshape the landscape of fat reduction treatments, making them safer and more accessible than ever before.
In conclusion, the recognition of CBL-514 in a top-tier journal marks not just a win for Caliway, but a promising future for non-invasive body contouring procedures. With expectations for the official publication in the second quarter of 2025, the anticipation around this innovative therapy continues to build momentum in the aesthetic medicine community.