Caliway Biopharmaceuticals announced the initiation of subject recruitment in CBL-0204 Phase 2b study. The study, approved by the U.S. FDA, will enroll 100 subjects in 14 clinical sites in the U.S. and Australia. CBL-0204 is a Phase 2b study evaluating the efficacy, safety and tolerability of CBL-514 injection, Caliway's leading candidate drug, in reducing abdominal subcutaneous fat.

The study will enroll 100 adult subjects with mild, moderate, or severe abdominal subcutaneous fat as assessed by the abdominal fat rating scale (AFRS). The primary efficacy endpoint is the percentage of the subjects with at least one-grade improvement reported by the investigator assessing with the AFRS. Currently, CBL-514 is the only product worldwide with similar efficacy as liposuction and the only non-surgical fat reduction drug for a large treatment area.

The previously completed clinical trial results have demonstrated significant differences in CBL-514's efficacy in reducing subcutaneous fat in the treated area with excellent safety and tolerability profiles. The CBL-0204 Phase2b study is expected to be completed in second quarter 2024. And the topline results are anticipated in third quarter 2024.

The Phase 3 pivotal study is expected to be applied in 2024. The current methods for fat reduction include non-invasive products and invasive surgery, such as liposuction and abdominal contour surgery. The efficacy of non-invasive products often takes more than twelve weeks to observe, and is generally poor with the limited treating body area.

The potential moderate to severe side effects of non-invasive products include tissue necrosis, nerve damage, scar tissue fibrosis, and Paradoxical adipose hyperplasia (PAH). Though the efficacy of surgery is more significant compared to approved non-surgery local fat reduction products, the surgery still comes with severe side effects and a high risk of death. According to the American Society of Plastic Surgeons' report, more than 60% of people are reluctant to undergo local fat reduction due to the fear of the side effects.

The medical needs for local fat reduction remain unmet.