Policy & Regulation
Caliway Biopharmaceuticals commences CBL-0204 Phase 2b study patient recruitment
1 June 2023 -

Caliway Biopharmaceuticals, a Taiwan-based biopharmaceutical company focusing on breakthrough medical aesthetics and inflammatory medicine discovery of small-molecule therapeutics, announced on Wednesday that it has started patient recruitment for its CBL-0204 Phase 2b study.

The study has been approved by the US FDA and will enrol 100 subjects in 14 clinical sites in the United States and Australia.

CBL-0204, a Phase 2b study, is assessing the efficacy, safety and tolerability of CBL-514 injection, the company's leading candidate drug, in decreasing abdominal subcutaneous fat. The study is enrolling 100 adult patients with mild, moderate, or severe abdominal subcutaneous fat as evaluated by the abdominal fat rating scale (AFRS). The study's primary efficacy endpoint is the percentage of patients with around one-grade improvement reported by the investigator assessing with the AFRS.

The CBL-0204 Phase 2b study should be completed in the second quarter of 2024 and the top-line results are expected in the third quarter of 2024. The Phase three pivotal study is expected to be implemented in 2024.