The Investigational New Drug (IND) application for CBL-0302 (Supreme-02), Caliway’s second multi-country pivotal phase 3 study for its localised fat reduction candidate CBL-514, has successfully passed the FDA’s 30-day review period.
Both global pivotal phase 3 studies, CBL-0301 and CBL-0302, are expected to begin patient enrolment shortly, with topline results anticipated in 2027 to support a future New Drug Application (NDA).
Taiwan’s TFDA and Australia’s HREC have approved CBL-0206, an Asia-Pacific phase 2 study of CBL-514, further bolstering Caliway’s ‘global and regional parallel’ development strategy.
Parallel advancement of global phase 3 studies and Asia-Pacific trials aims to solidify CBL-514’s regulatory foundation and maximise its long-term commercial potential worldwide.
Caliway plans to initiate both global pivotal phase 3 studies, CBL-0301 and CBL-0302, in the near term, anticipating clinical results in 2027. CBL-0302 utilises a randomised, double-blind, placebo-controlled design and expected to enrol approximately 320 participants across the United States, Canada and Australia to evaluate the efficacy, safety and tolerability of the CBL-514 injection. Clinical study applications for CBL-0302 have also been submitted to Health Canada and Australia.
The primary efficacy endpoints of CBL-0302 are uniquely rigorous, comprising (1) abdominal subcutaneous fat volume change as measured objectively by MRI, and (2) abdominal fat level improvement assessed by the Patient-Reported Abdominal Fat Rating Scale (PR-AFRS). These endpoints and the study’s design are strongly supported by Caliway’s previously completed phase 2b clinical studies, CBL-0204 and CBL-0205, which successfully met all primary endpoints.
