Caliway: CBL-514 Phase 2b Study Achieves All Efficacy Goals for Reducing Abdominal Fat

Caliway Biopharmaceuticals has announced promising results from a Phase 2b clinical trial of CBL-514, a first-in-class drug candidate for significant fat reduction in large areas. The study, recognized by both the U.S. FDA and the Australian TGA, successfully achieved all of its primary and secondary endpoints in both the Full Analysis Set (FAS) and Per-Protocol (PP) populations. These outcomes pave the way for a pivotal Phase 3 trial slated for 2025, marking a significant step forward in the development of potentially the first approved injectable treatment for large-area fat reduction.

The study, known as CBL-0204, is a multi-center, randomized, placebo-controlled trial focusing on the efficacy and safety of CBL-514 in reducing subcutaneous fat in the abdominal region. It enrolled 107 participants who exhibited moderate to severe subcutaneous abdominal fat as assessed by the Abdominal Fat Rating Scale (AFRS). Participants were divided into two groups to receive up to four treatments of either CBL-514 or a placebo, administered once every three weeks, with three subsequent follow-up visits over the next 12 weeks. The maximum dosage per treatment was 600 mg.

To ensure accurate efficacy assessments for future studies, the CBL-0204 trial employed the AFRS, an FDA-recommended tool, along with MRI scans to evaluate changes in subcutaneous fat volume in the treated areas. At 12 weeks post-treatment, 76.7% of those in the FAS population receiving CBL-514 showed at least a one-grade improvement on the Clinician Reported-Abdominal Fat Rating Scale (CR-AFRS), compared to just 18.9% in the placebo group. In the PP population, 81.8% demonstrated similar improvements, underscoring the drug's potential efficacy.

Secondary endpoints revealed further positive results. At 12 weeks after the final treatment, 32% of participants receiving CBL-514 reported at least a two-grade improvement in CR-AFRS, a stark contrast to 0% in the placebo group. Additionally, 50% of participants showed a reduction in subcutaneous fat volume of at least 150 mL at just four weeks post-treatment, as assessed by MRI, with no similar results in the placebo group. Notably, 58.8% of participants achieved at least a one-grade improvement in CR-AFRS after only a single treatment.

The safety profile of CBL-514 was favorable, aligning with earlier clinical studies. The main side effects were mild to moderate injection site reactions, suggesting the treatment is well-tolerated by most patients.

CBL-514 is an innovative small-molecule drug designed to reduce subcutaneous adiposity by inducing apoptosis of adipocytes, the cells responsible for storing fat. It achieves this without adverse systemic effects on the central nervous, cardiovascular, or respiratory systems. Early studies have shown that CBL-514 activates apoptosis mediators, promoting the breakdown and reduction of fat cells.

Caliway Biopharmaceuticals is exploring various applications for CBL-514 beyond fat reduction, including treatment for Dercum's disease and cellulite. With over 520 subjects having participated in clinical trials across multiple indications, CBL-514 continues to demonstrate precise efficacy and a positive safety profile.

Caliway Biopharmaceuticals, based in Taiwan, is committed to advancing the field of aesthetic medicine and other therapeutic areas through innovative small-molecule drugs. As a leader in this field, Caliway remains focused on developing novel treatments that address unmet medical needs.