2025. 02
Date： 2025.02.03 -
Caliway Presented CBL-0204 Phase 2b Study Results of CBL-514 at IMCAS 2025 in Paris
- Breakthrough in Non-Surgical Fat Reduction: Caliway Biopharmaceuticals presented CBL-514 Phase 2b clinical data in two dedicated sessions at the IMCAS 2025 World Congress in Paris, demonstrating the potential of the world's first large-area localized fat reduction injectable. The presentations drew interest from the global aesthetic medicine community, including pharmaceutical companies and medical professionals exploring potential collaborations.
- Expert Endorsement: Internationally renowned dermatologist Dr. Michael H. Gold, MD, one of the principal investigators of the CBL-514 clinical study, described CBL-514 as a "market-transforming therapeutic innovation" during his presentations at IMCAS.
- Advancing Toward Global Phase 3 Studies: Caliway plans to initiate recruitment for two global pivotal Phase 3 clinical studies in the second half of 2025 to further evaluate CBL-514's efficacy and safety, aiming to become the first approved injectable for large-area localized fat reduction.
New Taipei City, February 3, 2025 – Caliway Biopharmaceuticals (Caliway, TWSE: 6919) presented key clinical findings from the CBL-0204 Phase 2b study at the IMCAS 2025 World Congress, one of the most prestigious global conferences in aesthetic medicine, attended by more than 18,000 medical professionals and industry leaders from across the globe.
The data was shared in two dedicated sessions on January 30 and February 1, delivered by Dr. Michael H. Gold, MD, a globally recognized dermatologist and one of the principal investigators of the CBL-514 clinical studies, providing an in-depth review of CBL-514’s latest clinical findings in localized fat reduction.
During the " Fat Reduction Treatments in 2025" and "Non-Surgical Body Contouring" sessions, Dr. Gold introduced CBL-514 as the first injectable for large-area localized fat reduction, emphasizing its promising safety and efficacy profiles:
In the CBL-0204 Phase 2b study, over 80% of participants in the CBL-514 treatment group achieved at least a 1-grade improvement on the Clinician Reported-Abdominal Fat Rating Scale (CR-AFRS) (p < 0.0005), and nearly 60% of participants achieved this result after just one treatment.
MRI assessments showed that post-treatment, participants experienced an average reduction of more than 30% in subcutaneous fat thickness, with statistically significant efficacy (p < 0.00001).
The study confirmed that CBL-514 reduced subcutaneous fat in the treated area without affecting untreated regions, and demonstrated a favorable safety and tolerability profile with no serious adverse event (SAE) reported.
Dr. Gold stated, "CBL-514 represents an innovation in non-surgical localized fat reduction, with the potential to redefine the aesthetic medicine market."
Strong Clinical Data Driving Global Industry Interest
CBL-514’s promising Phase 2b clinical results have drawn the attention from global pharmaceutical companies and medical professionals, many of whom have expressed interest in potential collaborations.
The AFRS scale used in the CBL-0204 and CBL-0205 Phase 2b studies categorizes abdominal fat accumulation into five grades, with Grade 3 (moderate) and Grade 4 (severe) participants enrolled in the study. Liposuction procedures typically improve AFRS by only one grade.
These findings reinforce CBL-514’s potential as a first-in-class non-surgical fat reduction therapy, further drawing interest from global industry leaders.
Advancing to Phase 3 Pivotal Studies in 2025
Caliway plans to submit two global multi-center Phase 3 pivotal trials (CBL-0301 and CBL-0302) IND to the U.S. FDA and Health Canada starting in Q2 2025. Subject recruitment is expected to begin in the second half of 2025, marking a critical milestone in the development of CBL-514 as the first injectable approved for large-area localized fat reduction.
Caliway remains committed to advancing biotech innovations globally and addressing unmet needs in aesthetic medicine with scientifically driven research.
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 9 completed clinical studies results for 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 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.
Disclaimer
This article and related information on this site contain forward-looking statements. The forward-looking information requires the Company to make numerous assumptions and is subject to inherent risks, uncertainties, and other factors that are beyond the control of the Company which may cause actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. The Company undertakes no obligation to timely inform, update, or revise the information on this site if circumstances should change.
- Expert Endorsement: Internationally renowned dermatologist Dr. Michael H. Gold, MD, one of the principal investigators of the CBL-514 clinical study, described CBL-514 as a "market-transforming therapeutic innovation" during his presentations at IMCAS.
- Advancing Toward Global Phase 3 Studies: Caliway plans to initiate recruitment for two global pivotal Phase 3 clinical studies in the second half of 2025 to further evaluate CBL-514's efficacy and safety, aiming to become the first approved injectable for large-area localized fat reduction.
New Taipei City, February 3, 2025 – Caliway Biopharmaceuticals (Caliway, TWSE: 6919) presented key clinical findings from the CBL-0204 Phase 2b study at the IMCAS 2025 World Congress, one of the most prestigious global conferences in aesthetic medicine, attended by more than 18,000 medical professionals and industry leaders from across the globe.
The data was shared in two dedicated sessions on January 30 and February 1, delivered by Dr. Michael H. Gold, MD, a globally recognized dermatologist and one of the principal investigators of the CBL-514 clinical studies, providing an in-depth review of CBL-514’s latest clinical findings in localized fat reduction.
During the " Fat Reduction Treatments in 2025" and "Non-Surgical Body Contouring" sessions, Dr. Gold introduced CBL-514 as the first injectable for large-area localized fat reduction, emphasizing its promising safety and efficacy profiles:
In the CBL-0204 Phase 2b study, over 80% of participants in the CBL-514 treatment group achieved at least a 1-grade improvement on the Clinician Reported-Abdominal Fat Rating Scale (CR-AFRS) (p < 0.0005), and nearly 60% of participants achieved this result after just one treatment.
MRI assessments showed that post-treatment, participants experienced an average reduction of more than 30% in subcutaneous fat thickness, with statistically significant efficacy (p < 0.00001).
The study confirmed that CBL-514 reduced subcutaneous fat in the treated area without affecting untreated regions, and demonstrated a favorable safety and tolerability profile with no serious adverse event (SAE) reported.
Dr. Gold stated, "CBL-514 represents an innovation in non-surgical localized fat reduction, with the potential to redefine the aesthetic medicine market."
Strong Clinical Data Driving Global Industry Interest
CBL-514’s promising Phase 2b clinical results have drawn the attention from global pharmaceutical companies and medical professionals, many of whom have expressed interest in potential collaborations.
The AFRS scale used in the CBL-0204 and CBL-0205 Phase 2b studies categorizes abdominal fat accumulation into five grades, with Grade 3 (moderate) and Grade 4 (severe) participants enrolled in the study. Liposuction procedures typically improve AFRS by only one grade.
These findings reinforce CBL-514’s potential as a first-in-class non-surgical fat reduction therapy, further drawing interest from global industry leaders.
Advancing to Phase 3 Pivotal Studies in 2025
Caliway plans to submit two global multi-center Phase 3 pivotal trials (CBL-0301 and CBL-0302) IND to the U.S. FDA and Health Canada starting in Q2 2025. Subject recruitment is expected to begin in the second half of 2025, marking a critical milestone in the development of CBL-514 as the first injectable approved for large-area localized fat reduction.
Caliway remains committed to advancing biotech innovations globally and addressing unmet needs in aesthetic medicine with scientifically driven research.
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 9 completed clinical studies results for 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 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.
Disclaimer
This article and related information on this site contain forward-looking statements. The forward-looking information requires the Company to make numerous assumptions and is subject to inherent risks, uncertainties, and other factors that are beyond the control of the Company which may cause actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. The Company undertakes no obligation to timely inform, update, or revise the information on this site if circumstances should change.