• The first and only lipolytic injectable for large area – CBL-514's last Phase 2b study has been completed
• Both CBL-514 Phase 2b studies used efficacy assessment tools, AFRS and MRI, in accordance with the U.S. FDA recommendation
• CBL-514 Pivotal Phase 3 study is expected to initiate subject recruitment in H2 2025

Caliway Biopharmaceuticals (Caliway) completed CBL-514 Phase 2b study for non-surgical fat reduction (CBL-0205, clinicaltrials.gov ID: NCT06005441) on October 22^nd, 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.

In January 2024, Caliway received approval from the Australian HREC to conduct CBL-514 Pivotal Phase 3 trial for non-surgical fat reduction. The company anticipates IND approvals from the U.S. FDA and Health Canada (HC) by 2025, with subject recruitment expected to initiate in H2 2025.

Treatment Option for Subcutaneous Fat Reduction

The current subcutaneous fat reduction procedures include invasive surgery, such as liposuction and abdominoplasty, and non-invasive products, including deoxycholic acid injection and other medical devices. A published study has shown that liposuction could remove an average of 183.3mL of abdomen fat for patients with a body mass index (BMI) <25 kg/m², yet it involves a lengthy procedure that is generally performed in an operating room and may also carry the risk of unfavorable outcomes, such as periumbilical under-correction, permanent skin creases, and other moderate to severe side effects. The efficacy of non-invasive procedures is generally less optimal, with limited treatment areas and potential side effects, including tissue necrosis, nerve damage, and paradoxical adipose hyperplasia (PAH).