#Taiwan #New Taipei City #Caliway Biopharmaceuticals #CBL-514 #fat reduction

CBL-514 Phase 2b Study Results: A Major Milestone in Fat Reduction Research

Caliway Biopharmaceuticals, a pioneering force in pharmaceutical innovation, recently announced groundbreaking results from their second Phase 2b clinical study (CBL-0205) for CBL-514, the world's first investigational drug aimed at localized fat reduction. The study's outcomes have set the stage for a significant advancement in aesthetic medicine, with the potential to reshape treatment protocols for fat reduction.

Study Overview

Conducted across 15 clinical sites in the U.S. and Canada, this double-masked, randomized, placebo-controlled study enrolled 173 participants suffering from moderate (Grade 3) to severe (Grade 4) abdominal fat accumulation. Each participant received allocated treatments of CBL-514 subcutaneously, followed by multiple follow-up assessments to gauge the drug's effectiveness and safety.

Key Findings

The results of the CBL-0205 study were impressive:

• - Primary Endpoint Achieved: MRI data revealed that 54.2% of participants who received CBL-514 achieved at least a 20% reduction in fat volume four weeks after treatment, in stark contrast to a 0% reduction in the placebo group (p<0.00001).
• - Significant Secondary Endpoints: The CBL-514 group outperformed other cohorts (CBL-A1 and CBL-A2), showing not only substantial reductions in fat volume but also noteworthy improvements in abdominal fat ratings. The average reduction in fat volume was 166.6 mL, compared to increases in the placebo group.
• - Clinically Relevant Improvements: A remarkable 75.7% of participants reported at least a one-grade improvement on the Clinical Abdominal Fat Rating Scale (CR-AFRS), highlighting the drug's efficacy compared to just 27.5% in the placebo cohort.

These results underscore CBL-514's robust capacity for fat reduction, consistently supported by data from previous Phase 2b studies.

Safety and Tolerability

Importantly, the study assessed the safety of CBL-514, confirming that adverse events were primarily mild to moderate, with no serious drug-related events reported. This positive safety profile aligns with previous studies, reinforcing the compound's potential as a go-to fat reduction therapy.

Future Directions

Caliway is not resting on its laurels; poised for progress, the completion of this Phase 2b study positions CBL-514 for pivotal Phase 3 trials set to commence in the latter half of 2025. These upcoming studies aim to enroll around 600 participants globally, further solidifying CBL-514's application in the aesthetic medicine domain.

The ambition of Caliway is to revolutionize fat reduction methods, addressing unmet needs in the market. With the solid efficacy and safety profiles shown in the clinical studies to date, CBL-514 is on track to establish itself as a leader in non-invasive fat reduction therapies.

Conclusion

As modern society increasingly seeks safe and effective methods for body sculpting, CBL-514 emerges as a beacon of progress in pharmaceutical care. The successful Phase 2b results promise to set a new standard for treatments in aesthetic medicine, with Caliway at the forefront of this transformative journey.

For more details on the Phase 2b study, please visit clinicaltrials.gov.