Caliway Biopharmaceuticals (Caliway) announces that Australian Bellberry HREC has approved Caliway’s application to initiate CBL-514’s Pivotal Phase 3 study (CBL-0301 Phase 3) for subcutaneous fat reduction.
“We are all delighted to see CBL-514 showing its potential to become the new, promising, non-invasive fat reduction treatment in the previous Phase 2 study,” said Vivian Ling, CEO of Caliway. “The following CBL-514 Phase 3 study will further investigate its fat reduction efficacy compared with placebo with the U.S. FDA-suggested fat change assessment tool, Abdominal Fat Rating Scale (AFRS) and MRI.”
The CBL-0301 Pivotal Phase 3 study is a multicountry and multicenter study that will recruit 300 subjects to evaluate CBL-514’s efficacy, safety, and tolerability for reducing abdominal subcutaneous fat. The primary endpoint will be the percentage of subjects with at least 1-grade improvement on AFRS compared with placebo. The AFRS, developed by Caliway under the U.S. FDA recommendation, is a scale to assess fat accumulation severity and categorize subjects into 5 grades (1-5). The number indicated the severity of abdominal fat accumulation, with 1 indicating none/minimal and 5 indicating very severe.
Currently, there are two CBL-514 Phase 2b studies for subcutaneous fat reduction ongoing in the U.S., Australia, and Canada. To optimize the Phase 3 study protocol and to increase its successful rate of meeting endpoints, both Phase 2b studies were designed to simulate the Phase 3 study with the same efficacy assessment tools, AFRS and MRI. Caliway will submit the final Pivotal Phase 3 study protocol as soon as the preliminary result of the CBL-0204 Phase 2b study is announced.
Following up, Caliway will submit the CBL-0301 Phase 3 IND application to the U.S. FDA, EMA, and other countries’ regulatory authorities. The subject recruitment will be initiated after receiving IND approval from the U.S. FDA. Caliway will also prepare to submit the IND application of another CBL-514’s Pivotal CBL-0302 Phase 3 study for subcutaneous fat reduction.
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