2025. 03
Date： 2025.03.20 -
Caliway Selected to Present CBL-514 Phase 2b Study Results at AMWC 2025 in Monaco
- Caliway’s localized fat reduction drug, CBL-514, has been selected for presentation at the globally renowned AMWC Aesthetic & Anti-Aging Medicine World Congress under the "Body & Fat Treatment" session, highlighting CBL-0204 Phase 2b study results.
- The CBL-0204 Phase 2b results demonstrate the strong efficacy and safety profile of CBL-514 in localized adipose reduction, with all primary and secondary endpoints significantly met. Over 75% of participants in the study showed at least a 1-grade improvement in AFRS (Abdominal Fat Rating Scale), as evaluated by both investigators and participants (p<0.00005, Full Analysis Set population, FAS population).
New Taipei City, March 20, 2025 – Caliway Biopharmaceuticals (TWSE: 6919) is pleased to announce that it will present the CBL-514 Phase 2b study results (CBL-0204 Phase 2b) in localized fat reduction at AMWC 2025 (Aesthetic & Anti-Aging Medicine World Congress), taking place on March 27 in Monaco.
The presentation will be delivered by Dr. Peter Peng, President of the Taiwan Society for Dermatological & Aesthetic Surgery (TSDAS). He will present key findings from the CBL-0204 Phase 2b study, conducted across 12 research centers in the United States and Australia, which evaluated the efficacy and safety of CBL-514 in localized fat reduction and met all primary and secondary endpoints.
The study results were evaluated using MRI (Magnetic Resonance Imaging) to assess subcutaneous fat volume reduction, along with the AFRS (Abdominal Fat Rating Scale), an FDA-recommended efficacy assessment tool for pivotal Phase 3 studies that categorizes abdominal fat severity into 5 grades, serving as the study’s primary efficacy endpoint.
Additionally, before-and-after MRI imaging of participants will be presented to highlight CBL-514’s precise and remarkable efficacy in non-surgical localized fat reduction, as well as its strong market potential.
Dr. Peter Peng, with over 26 years of experience in dermatology, specializes in skin structure research and anti-aging treatments. Having been invited to speak at over 300 international medical conferences worldwide, he is recognized as a leading authority in aesthetic dermatology and non-surgical fat reduction.
AMWC is a premier international congress in aesthetic medicine and anti-aging, bringing together global experts in dermatology, plastic surgery, and biotechnology.
The 23rd edition in 2025 will be held in Monte Carlo, Monaco, attracting over 15,000 medical professionals and industry leaders who gather to discuss cutting-edge aesthetic innovations and future trends.
CBL-514 Study Presentation Info at AMWC 2025:
- Session: Body & Fat Treatment
- Presentation Title: CBL-514 Injections Demonstrated Promising Efficacy Data Evaluated by the Fat Rating Scale and MRI in the Phase 2b Study
- Date & Time: Thursday, March 27, 2025, 9:30 AM
- Location: Monte Carlo, Monaco | Grimaldi Forum | PINEDE 1
For more information on CBL-0204 Phase 2b study results, visit: 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
*About the Full Analysis Set (FAS) Population in Clinical Studies
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.*About CBL-514
CBL-514, a 505(b)(1) and first-in-class small-molecule drug developed by Caliway, is the world's first injectable lipolysis drug that induces adipocyte apoptosis to reduce subcutaneous fat in targeted areas without causing any systematic side effects on the central nervous system, cardiovascular system, and respiratory system. CBL-514 has demonstrated fewer side effects, superior efficacy, and fewer required treatments compared with existing surgical procedures and other non-invasive localized fat reduction solutions.Caliway is currently investigating multiple indications for CBL-514, including non-surgical fat reduction and moderate-to-severe cellulite. A derivative compound, CBL-514D, is being developed for indications including rare diseases such as Dercum’s disease and Obstructive Sleep Apnea (OSA). As of the end of November 2024, Caliway has enrolled a total of 520 subjects in clinical studies related to CBL-514. To date, 10 clinical studies have been completed with results available, and all these studies have met their efficacy endpoints and safety parameters. CBL-514 has demonstrated precise efficacy with a favorable safety profile across multiple indications, showing outstanding statistical significance (p<0.00001 or p<0.0001) in both ITT and FAS populations. Caliway plans to initiate subject recruitment for two pivotal global Phase 3 studies for localized fat reduction in the second half of 2025.