Announcement • Apr 13
Caliway Biopharmaceuticals Announces Clinical Results for Fat Reduction Drug Candidate Cbl-514
Caliway Biopharmaceuticals announced that clinical results from CBL-0204 Phase 2b, a study of its first-in-class large-area localized fat reduction drug candidate, CBL-514, for subcutaneous fat reduction, have been accepted by the Aesthetic Surgery Journal (ASJ), a globally recognized authority in aesthetic medicine. This marks the third time that Phase 2 clinical results of CBL-514 for localized fat reduction have been accepted by ASJ, the world's top-ranked journal in aesthetic and plastic surgery, further validating CBL-514's outstanding efficacy and safety profile while reinforcing its clinical value and international academic standing as an innovative non-surgical localized fat reduction therapy. CBL-0204 is a multi-center, randomized, placebo-controlled Phase 2b clinical study approved by both the U.S. Food and Drug Administration (FDA) and the Australia's Human Research Ethics Committee (HREC), enrolling a total of 107 participants. Both efficacy endpoints, including MRI and AFRS (Abdominal Fat Rating Scale), and the study design, are highly aligned with the framework of global pivotal Phase 3 studies, the acceptance of this study by ASJ further endorsed the global development of CBL-514 for subcutaneous fat reduction. Final statistical results from CBL-0204 showed that both the primary and secondary efficacy endpoints were successfully met. In the Per-Protocol (PP) population, as many as 82.6% of participants achieved at least 1-grade improvement in the Clinician Reported Abdominal Fat Rating Scale (CR-AFRS), with more than half of participants achieving this result after only one treatment. Notably, 42.1% of participants also achieved at least a 2-grade improvement in the Patient Reported Abdominal Fat Rating Scale (PR-AFRS), compared with 0% in the placebo group, reaching statistical significance (p<0.001). Overall data further showed that, in addition to visibly reducing abdominal fat accumulation, MRI assessments, which are currently recognized as one of the most objective and accurate methods for evaluating fat thickness and volume, demonstrated that more than 60% of participants achieved at least a 20% reduction in fat volume in the treated area (vs. 0% in the placebo group, p<0.00005), confirming significant localized fat reduction efficacy. Caliway noted that, compared with many existing fat reduction treatments, which are more difficult to objectively quantify volume changes across large treatment areas, CBL-514 clinical studies are able to use MRI to demonstrate fat volume differences before and after treatment, further enhancing the credibility and persuasiveness of its clinical data. In terms of safety, CBL-514 demonstrated favorable overall safety and tolerability, with the major adverse events consisting primarily of common mild to moderate injection site reactions. In the current localized fat reduction market, invasive procedures such as liposuction can deliver visible efficacy, but are accompanied by higher recovery burden and surgical risks. Meanwhile, existing non-surgical localized fat reduction therapies still broadly face challenges in fully balancing efficacy, safety, and tolerability. This underscores the significant unmet need for innovative therapies that can provide both strong efficacy and a favorable safety profile. As the world's first drug candidate designed to induce adipocyte apoptosis and precisely reduce subcutaneous fat in large treatment areas, CBL-514 has continued to demonstrate its differentiated advantages through multiple strong clinical datasets recognized by international renowned journals. CBL-514, a 505(b)(1) and first-in-class small-molecule drug developed by Caliway, is the world's first injectable lipolysis drug that induces adipocyte apoptosis to reduce subcutaneous fat in targeted areas with no systemic safety risks identified and good tolerability. To date, 10 clinical trials with a total of 544 subjects have been completed with all efficacy and safety endpoints met. CBL-514 is being developed across multiple indications, including reduction of subcutaneous fat (non-surgical localized fat reduction) and moderate-to-severe cellulite. CBL-514D, the same active pharmaceutical ingredients (APIs) but under different formulation, is being studied for additional indications such as Dercum's disease and more.
