Caliway Biopharmaceuticals (Caliway) completed CBL-514 Phase 2b study for non-surgical fat reduction (CBL-0205, clinicaltrials.gov ID: NCT06005441) on October 22nd, 2024, with the topline results anticipated in Q1 2025. CBL-0205, the last of the two CBL-514 Phase 2b studies for fat reduction, was designed in accordance with the U.S. FDA recommendations for the upcoming Pivotal Phase 3 study. The possible success of two Phase 2b studies meeting endpoints will make CBL-514 the first fat reduction product for large area to enter the Phase 3 study.
CBL-514 is a combination of multiple APIs, including CBL-A1 and CBL-A2. The CBL-0205 study is a multicenter, single-blinded, randomized, placebo-controlled Phase 2b trial designed to evaluate the efficacy, safety, and tolerability of CBL-514 versus its individual API, CBL-A1 and CBL-A2, as well as the placebo. A total of 173 participants were enrolled and randomly allocated to four groups to receive up to four courses of CBL-514, CBL-A1, CBL-A2, or placebo treatment, respectively, once every three weeks.
Currently, there are two CBL-514 Phase 2b studies (CBL-0204 and CBL-0205) for subcutaneous fat reduction with the topline results anticipated, in Q4 2024 and Q1 2025, respectively. Both these trials were designed to simulate the Phase 3 study by using the same efficacy assessment tools, Magnetic Resonance Imaging (MRI) and Abdominal Fat Reduction Scale (AFRS, a scale recommended by the U.S. FDA, developed by Caliway), to increase the success of meeting Phase 3 endpoints. Moreover, to minimize potential biases in the single-blinded design, both Phase 2b trials‘ MRI readings and analyses underwent blinded Outcomes Assessor from independent organization before being finalized by the CRO for statistical analysis.
