Caliway Completed CBL-514 Phase 2b Study (CBL-0205) for Subcutaneous Fat Reduction

• 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

NEW TAIPEI CITY, Oct. 23, 2024 /PRNewswire/ -- 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.

About 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).

About CBL-0205 Phase 2b Study

The CBL-0205 study is a multi-country, multi-center, randomized, placebo-controlled Phase 2b study to evaluate CBL-514's efficacy and safety in reducing subcutaneous fat. A total of 173 participants with moderate to severe abdominal subcutaneous fat accumulation as assessed by AFRS* were enrolled in the U.S. and Canadian clinical sites to receive up to four treatments of allocated study drug administered subcutaneously to the abdomen, once every three weeks, along with two follow-up visits at 4 weeks and 8 weeks after the last treatment.

The primary efficacy endpoint is the percentage of subjects with at least 20% fat reduction as measured by MRI. The secondary efficacy endpoints include the percentage of subjects with at least 25% fat reduction measured by MRI and the percentage of subjects with at least 1-grade improvement reported via Clinician Reported-AFRS grading.

*AFRS is a scale developed and validated in accordance with U.S. FDA recommendations and relevant regulations. It uses a 1 to 5 grading system to assess abdominal subcutaneous fat accumulation; higher scores indicate greater severity of subcutaneous fat accumulation, and different grades indicate clinically significant differences.

About CBL-514

CBL-514, a potentially first-in-class small-molecule drug, is a lipolysis injection that can induce adipocyte apoptosis and lipolysis to reduce subcutaneous adiposity in treatment areas without causing any systematic side effects on the central nervous system, cardiovascular system, and respiratory system. Caliway's preclinical studies have shown that CBL-514 upregulates the apoptosis mediators caspase 3 and Bax/Bcl-2 ratio and then induces adipocyte apoptosis in vivo and in vitro.

Caliway is investigating multiple indications for CBL-514, including non-invasive subcutaneous fat reduction, Dercum's disease, and cellulite. To date, a total of 521 subjects have enrolled in CBL-514 clinical studies, with 317 subjects having received CBL-514 injection treatment. According to the results from 8 completed clinical studies of three indications, CBL-514 has demonstrated precise efficacy with a favorable safety profile. The global Pivotal Phase 3 study for non-surgical fat reduction is expected to be initiated in 2025.

About Caliway Biopharmaceuticals

Caliway Biopharmaceuticals (Caliway) is a Taiwan-headquartered, clinical-stage biopharmaceutical company driven to breakthrough drug discovery of novel small-molecule therapeutics. Listed on the Taipei Exchange (TWSE-6919), Caliway aims to become an innovative pharmaceutical leader in aesthetic medicine and other diseases.

For more information, please visit: https://www.caliway.com.tw/en

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SOURCE Caliway Biopharmaceuticals