Caliway Announces Successful Study Results from CBL-0204, a CBL-514 Phase 2b Study for Reducing Abdominal Subcutaneous Fat, Met All Primary and Secondary Efficacy Endpoints

- CBL-514 is the first-in-class new drug candidate for large-area fat reduction. CBL-0204 Phase 2b study, approved by the U.S. FDA and AU TGA, met all the primary and secondary efficacy endpoints in FAS (full analysis set) population and PP (per-protocol) population, paving its way to a global pivotal Phase 3 study in 2025.

- Over 80% of participants in the PP population achieved at least 1-grade improvement using CR-AFRS (Clinician Reported-Abdominal Fat Rating Scale) and PR-AFRS (Patient Reported-Abdominal Fat Rating Scale).

- Almost 60% of participants in the PP population achieved at least 1-grade improvement using CR-AFRS after one CBL-514 treatment.

- Compared to the placebo group, CBL-514 can reduce over 30% of abdominal subcutaneous fat thickness in the PP population.

NEW TAIPEI CITY, Dec. 11, 2024 /PRNewswire/ -- Caliway Biopharmaceuticals (Caliway) announced the study results of the CBL-514 Phase 2b study for subcutaneous fat reduction (CBL-0204 Phase 2b study, NCT05736107), which met all the primary and secondary efficacy endpoints in the FAS (Full analysis set) and PP (Per-protocol) population analysis. Notably, the primary endpoint in the FAS population analysis showed that, at 12 weeks after the final treatment, 76.7% of patients treated with CBL-514 compared with placebo (18.9%) achieved at least 1-grade improvement reported by the Investigator using the Clinician Reported-Abdominal Fat Rating Scale (CR-AFRS) (p=0.00004). Additionally, the study results demonstrated a favorable safety and tolerability profile, paving its way to a global muti-center Pivotal Phase 3 study in 2025, shading light of becoming the first approved injectable for large area fat reduction.

CBL-0204 is a multi-center, randomized, placebo-controlled Phase 2b study evaluating CBL-514's efficacy and safety in reducing subcutaneous fat in the abdominal area. The study enrolled 107 participants with moderate to severe abdominal subcutaneous fat assessed by the Abdominal Fat Rating Scale (AFRS). The participants were randomized 1:1 to receive up to 4 courses, once every 3 weeks of CBL-514 or placebo treatments, followed by three follow-up visits at 4, 8, and 12 weeks after the last treatment. The maximum dose was 600 mg per treatment.

To enhance the success rate of meeting efficacy endpoints in the future CBL-514 Pivotal Phase 3 study, the CBL-0204 study adopted the U.S. FDA-recommended efficacy assessment tool, AFRS and MRI (Magnetic Resonance Imaging) to assess the subcutaneous fat volume change in the treated area.

Primary Endpoint

• In FAS population, at 12 weeks after the last treatment, 76.7% of participants treated with CBL-514 compared with placebo (18.9%) achieved at least 1-grade improvement reported by the Investigator using the CR-AFRS (p=0.00004). In PP population, at 12 weeks after the last treatment, 81.8% of participants treated with CBL-514 compared with placebo achieved at least 1-grade improvement reported by the Investigator using the CR-AFRS (p<0.0005).

Secondary Endpoints 

• At 12 weeks after the last treatment, 32% of participants treated with CBL-514, compared with placebo (0%), achieved at least 2-grade improvement reported by the Investigator using the CR-AFRS (p<0.002).
• In FAS population, at 12 weeks after the last treatment, 76.7% of participants treated with CBL-514, compared with placebo (19.4%), achieved at least 1-grade improvement reported by participants using the PR-AFRS (p=0.00004). In PP population, at 12 weeks after the last treatment, 81.8% of participants treated with CBL-514, compared with placebo, achieved at least 1-grade improvement reported by participants using the PR-AFRS (p<0.0002).
• At 4 weeks after the last treatment, 50% of participants treated with CBL-514 lost at least 150mL (p< 0.00001) of subcutaneous fat volume, compared with placebo (0%), as assessed by MRI.
• Compared to the placebo group, the CBL-514 group showed a change of -27.1% in abdominal subcutaneous fat thickness (95% CI: -32.3%, -21.8%, p< 0.00001) at 4 weeks after the final treatment.
• 58.8% of the participants only required one CBL-514 treatment to achieve at least 1-grade CR-AFRS improvement.

Overall, the safety and tolerability profiles of CBL-514 demonstrated in the study were favorable and consistent with previous clinical studies of CBL-514. The major TEAEs were ISRs (injection site reactions) that were mild and moderate.

For more information regarding CBL-0204 Phase 2b study, please visit: https://clinicaltrials.gov/study/NCT05736107

About AFRS

AFRS is a scale developed by Caliway and validated following U.S. FDA recommendations and relevant regulations. In accordance with the FDA's guideline of Patient-Focused Drug Development, the primary endpoint of this study was to assess the efficacy of CBL-514 in improving the abdominal fat level using the Abdominal Fat Rating Scale (AFRS). The AFRS includes the Clinician Reported-AFRS (CR-AFRS) designed for physicians and the Patient Reported-AFRS (PR-AFRS) designed for participants. They were used to assess the response rate based on the physician's evaluation and the participant's self-assessment, respectively. The scale categorizes abdominal fat into five grades from Grade 1 (None/Minimal) to Grade 5 (Very Severe), with higher scores indicating higher severity of abdominal fat, and different grades indicating clinically significant differences.

About the Full Analysis Set (FAS) population

The FAS population includes all eligible participants who were randomized to receive at least one course of study drug and contributed qualified baseline efficacy data, and at least one post-dose efficacy data point. According to ICH E9 Statistical Principles for Clinical Trials, the analysis results of FAS and the Intention-to-Treat (ITT) are the same.

About CBL-514

CBL-514, a first-in-class small-molecule drug, is a lipolysis injectable 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 520 subjects have enrolled in CBL-514 clinical studies. According to 10 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 will be conducted 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