Caliway Announces CBL-514 Second Phase 2b Study Results (CBL-0205) Met Endpoints

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Feb 10, 2025, 01:15 ET

CBL-514, the world's first investigational drug for large-area localized fat reduction, has demonstrated significant efficacy in its second and the last Phase 2b study (CBL-0205) before Phase 3.
54.2% of participants in the CBL-514 group achieved at least 20% fat volume reduction four weeks after treatment.
Nearly 80% of the CBL-514 treatment group achieved at least 1 grade improvement in CR-AFRS in the PP population. These study results align with the company's previous Phase 2b (CBL-0204) results, demonstrating the consistency of CBL-514's efficacy, safety, and tolerability.

NEW TAIPEI CITY, Feb. 9, 2025 /PRNewswire/ -- Caliway Biopharmaceuticals (TWSE-6919) announced today that CBL-514's second Phase 2b clinical study (CBL-0205), sprung across 15 sites in the U.S. and Canada, successfully met its primary and all critical secondary efficacy endpoints.

With this success, CBL-514 has now completed all Phase 2 clinical studies for localized fat reduction, positioned for the upcoming global multi-center pivotal Phase 3 studies.

CBL-514 Phase 2b: Study Design and Data Highlights

CBL-0205 Phase 2b is a multi-center, double-masking (Participant and Outcomes Assessor), randomized, placebo-controlled clinical study approved by the U.S. FDA and Health Canada. This was the largest CBL-514 study to date, enrolling 173 participants with moderate (Grade 3) or severe (Grade 4) abdominal fat accumulation, as assessed by the Abdominal Fat Rating Scale (AFRS). Each participant received up to 4 treatments of the allocated study drug administered subcutaneously to the abdomen, once every 3 weeks, followed by four and eight weeks of efficacy and safety follow-up visits after the final treatment. The key highlights of the study results include:

Primary Endpoint - Percentage of participants achieving at least 20% fat volume reduction compared to placebo.

MRI data showed that 54.2% of participants in the CBL-514 group achieved at least 20% fat volume reduction at four weeks after the final treatment, significantly higher than 0% in the placebo group (p<0.00001).
Secondary Endpoints:

(1) Percentage of participants achieving at least 20% fat volume reduction compared to CBL-A1 and CBL-A2.

MRI data showed that 54.2% of participants in the CBL-514 group achieved at least 20% fat volume reduction at four weeks after the final treatment, significantly outperforming compared to 17.4% in the CBL-A1 group (p<0.02) and 7.7% in the CBL-A2 group (p<0.0005).

(2) Absolute fat volume reduction (mL) compared to placebo, CBL-A1 and CBL-A2.

The CBL-514 group participants achieved an average of 166.6 mL subcutaneous fat volume reduction four weeks after the final treatment, significantly greater than the 15.7 mL increase in fat volume observed in the placebo group (p<0.00001). Compared to CBL-A1 and CBL-A2 groups, CBL-514 demonstrated a significantly higher absolute reduction (CBL-514: 166.6 mL vs. CBL-A1: 69.9 mL, p<0.00005; CBL-514 vs. CBL-A2: 70.5 mL, p<0.00005).

(3) Percentage reduction in fat volume (%) compared to placebo, CBL-A1 and CBL-A2.

The CBL-514 group participants demonstrated a mean fat volume reduction of 22.4% four weeks after the final treatment, significantly greater than the 1.8% increase in the placebo group (p<0.00001).

Compared to CBL-A1 and CBL-A2 groups, CBL-514 demonstrated a significantly higher percentage reduction in subcutaneous fat volume (CBL-514: 22.4% vs. CBL-A1:10.5%, p<0.0002; CBL-514 vs. CBL-A2: 11.7%, p<0.0005).

(4) Abdominal Fat Rating Scale (AFRS) improvement compared to placebo.

• Four weeks after the final treatment, 75.7% of participants in the CBL-514 group achieved at least 1 grade CR-AFRS improvement as assessed by investigators, compared to 27.5% in the placebo group (p< 0.00005).

• Similarly, 73.0% of participants in the CBL-514 group achieved at least 1 grade PR-AFRS improvement as assessed by participants, significantly higher than 20.0% in the placebo group (p<0.00002).

For Grade 3 (moderate) or Grade 4 (severe) participants, liposuction procedure would typically improve only 1-grade AFRS. These results highlight that CBL-514 effectively reduces subcutaneous fat and delivers noticeable improvements within four weeks, as reported by physicians and participants.
Safety and Tolerability:

Overall, the safety and tolerability profiles of CBL-514 demonstrated in the study were favorable and consistent with previous clinical studies of CBL-514, with no drug-related serious adverse event (SAE) or systematic side effects reported. The most TEAEs were mild to moderate ISRs (injection site reactions).

Looking Ahead: Pivotal Phase 3 Studies to Begin

To date, Caliway has completed 7 CBL-514 clinical studies for localized fat reduction, covering 474 participants, with each study meeting its primary efficacy endpoint. These consistent and reproducible results demonstrated the product's strong efficacy and safety profile, providing a solid foundation as the company moves toward global pivotal Phase 3 studies. Caliway plans to initiate subject recruitment for two pivotal global Phase 3 studies in the second half of 2025, with a total enrollment of approximately 600 participants. CBL-514 aims to set a new standard in the aesthetic medicine market by addressing unmet needs and providing a groundbreaking alternative to existing treatments.

For more information regarding CBL-0205 Phase 2b study (NCT06005441), please visit: https://clinicaltrials.gov/study/NCT06005441?intr=cbl-514&page=2&rank=11

About AFRS

AFRS is a scale developed by Caliway and validated following U.S. FDA recommendations and relevant regulations. Following 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 CBL-514

CBL-514, a 505(b)(1) and 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 mediator 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 participants have been 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. Caliway plans to initiate two pivotal global Phase 3 studies for non-surgical fat reduction in the second half of 2025.

About Caliway Biopharmaceuticals

Caliway Biopharmaceuticals (Caliway) is a clinical-stage biopharmaceutical company driven to breakthrough drug discovery of novel small-molecule therapeutics. Listed on the Taiwan 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