2024. 12
Date： 2024.12.19 -
Caliway to Present CBL-514 Phase 2b Study Results for Subcutaneous Fat Reduction at IMCAS 2025 in Paris
--The findings from the CBL-0204 Phase 2b clinical trial have been selected for presentation at IMCAS, the premier global congress in aesthetic medicine. The data will be highlighted in both the 2025 focus session on advances in fat reduction therapies and further detailed in the Non-surgical Body Contouring session through an oral presentation.
--The CBL-0204 Phase 2b results underscore the remarkable efficacy and safety profile of CBL-514 for localized adipose reduction. Both primary and secondary endpoints were met, establishing CBL-514 as the potentially first injectable therapy for large-area fat reduction. This trial was also the first trial adopted FDA-recommended metrics, including the SCALE and MRI-based assessments paving it’s way for a pivotal global Phase 3 clinical trial slated to commence in 2025
New Taipei City, December 18th, 2024 – Caliway Biopharmaceuticals (Caliway) is pleased to announce that the company will present CBL-514 Phase 2b study results (CBL-0204 Phase 2b) at the 26th IMCAS World Congress in Paris, France. CBL-514 is the first injectable for large-area fat reduction, with Phase 2b study results showing over 80% of CBL-514 treated participants achieved at least 1 grade of AFRS (abdominal fat rating scale) improvement. Dr. Michael H. Gold, the major principal investigator of Caliway’s clinical trials for abdomen subcutaneous fat reduction, will present CBL-0204 Phase 2b topline results in the Non-surgical Body Contouring session on February 1st, 2025, at 3 PM (Central European Time, GMT+1 hour).
Title：Fat Reduction Treatments in 2025 – What’s New and What Works With EBD’s and Injectables View
Date/Time:：Thursday 30 January 2025 at 11:54 pm
Venue: Room 402 - Level 4, Palais des Congrès de Paris(2 Pl de la Pte Maillot, 75017 Paris, France)
Session 2: IMCAS World Congress 2025 | Non-surgical body contouring
Title：A novel non-surgical fat reduction treatment: A Phase 2b study investigating CBL-514 injection’s efficacy in reducing abdomen subcutaneous fat
Date/Time: Saturday, 1 February 2025 at 3 PM (Central European Time, GMT+1 hour)
Venue: Room 401 - Level 4, Palais des Congrès de Paris(2 Pl de la Pte Maillot, 75017 Paris, France)
https://www.imcas.com/en/attend/imcas-world-congress-2025/program/session/56195#lectures
About IMCAS World Congress
IMCAS World Congress is a medical aesthetics-dedicated event that gathers over 18,700 healthcare and industry professionals to provide a global overview of the latest breakthroughs and innovations in the dermatology, plastic surgery, and aging science community. For more information, please visit: https://www.imcas.com/en/attend/imcas-world-congress-2025
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 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.
--The CBL-0204 Phase 2b results underscore the remarkable efficacy and safety profile of CBL-514 for localized adipose reduction. Both primary and secondary endpoints were met, establishing CBL-514 as the potentially first injectable therapy for large-area fat reduction. This trial was also the first trial adopted FDA-recommended metrics, including the SCALE and MRI-based assessments paving it’s way for a pivotal global Phase 3 clinical trial slated to commence in 2025
New Taipei City, December 18th, 2024 – Caliway Biopharmaceuticals (Caliway) is pleased to announce that the company will present CBL-514 Phase 2b study results (CBL-0204 Phase 2b) at the 26th IMCAS World Congress in Paris, France. CBL-514 is the first injectable for large-area fat reduction, with Phase 2b study results showing over 80% of CBL-514 treated participants achieved at least 1 grade of AFRS (abdominal fat rating scale) improvement. Dr. Michael H. Gold, the major principal investigator of Caliway’s clinical trials for abdomen subcutaneous fat reduction, will present CBL-0204 Phase 2b topline results in the Non-surgical Body Contouring session on February 1st, 2025, at 3 PM (Central European Time, GMT+1 hour).
Caliway CBL-0204 Study Results Presentation at IMCAS Information:
Session 1： IMCAS World Congress 2025 FOCUS SessionTitle：Fat Reduction Treatments in 2025 – What’s New and What Works With EBD’s and Injectables View
Date/Time:：Thursday 30 January 2025 at 11:54 pm
Venue: Room 402 - Level 4, Palais des Congrès de Paris(2 Pl de la Pte Maillot, 75017 Paris, France)
Session 2: IMCAS World Congress 2025 | Non-surgical body contouring
Title：A novel non-surgical fat reduction treatment: A Phase 2b study investigating CBL-514 injection’s efficacy in reducing abdomen subcutaneous fat
Date/Time: Saturday, 1 February 2025 at 3 PM (Central European Time, GMT+1 hour)
Venue: Room 401 - Level 4, Palais des Congrès de Paris(2 Pl de la Pte Maillot, 75017 Paris, France)
For more information regarding the session, please visit:
https://www.imcas.com/en/attend/imcas-world-congress-2025/program/session/55933https://www.imcas.com/en/attend/imcas-world-congress-2025/program/session/56195#lectures
About IMCAS World Congress
IMCAS World Congress is a medical aesthetics-dedicated event that gathers over 18,700 healthcare and industry professionals to provide a global overview of the latest breakthroughs and innovations in the dermatology, plastic surgery, and aging science community. For more information, please visit: https://www.imcas.com/en/attend/imcas-world-congress-2025
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 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.