Advancing Scientific Recognition in
Non-Surgical Fat Reduction
- Caliway's CBL-514 Phase 2 study (CBL-0202) has been accepted
for publication in Aesthetic Surgery Journal (ASJ), the
top-ranked journal in aesthetic medicine and plastic surgery.
- Clinical data (ITT population) showed that over 60% of
CBL-514-treated participants reduced at least 200mL of subcutaneous
fat within 8 weeks, demonstrating efficacy comparable to
liposuction, along with good safety, favorable tolerability, and no
downtime required.
- Caliway is advancing toward two pivotal Phase 3 studies for
localized fat reduction in Q3 2025, aiming to bring the first
injectable fat reduction therapy for large treatment areas to
market.
TAIPEI, March 12,
2025 /PRNewswire/ -- Caliway Biopharmaceuticals
(TWSE: 6919) announced that clinical results from the
CBL-0202 Phase 2 study of its novel localized fat reduction
drug, CBL-514, have been accepted for publication in the
Aesthetic Surgery Journal (ASJ), the world's leading
academic journal in aesthetic medicine and plastic surgery.
This publication further validates the efficacy and safety of
CBL-514 in localized fat reduction, highlighting its clinical value
as an innovative non-surgical therapy. Following the publication of
the CBL-16001 Phase 2a clinical results in ASJ in 2022, this
marks another significant achievement as CBL-514 gains continued
international recognition.
Caliway consistently adheres to the U.S. FDA's statistical
principles, utilizing complete Intent-to-treat (ITT) population and
Full Analysis Set (FAS) population data analyses in clinical
publications, ensuring the integrity and credibility of its
research results.
The accepted study was co-authored by Caliway's
R&D team and renowned dermatologists and plastic
surgeons, including Dr. Michael Gold, Dr. Joel
Schlessinger, Dr. Steven
Dayan, and Dr. Greg
Goodman, all recognized leaders in aesthetic medicine
and body contouring research. Caliway's CEO and Chief R&D
Officer, Vivian Ling, was
also directly involved in the study as a co-author.
Clinical results from the Phase 2 CBL-0202 study (ITT
population) revealed that 8 weeks after the final treatment,
over 60% of participants in the CBL-514 group
achieved a reduction of at least 200mL of subcutaneous fat
in the treated area, compared to 0% in the placebo group, achieving
statistical significance (p< 0.0001).
Notably, 42.9% of these participants achieved at least a
150mL reduction in subcutaneous fat after only one
treatment. Moreover, Per-Protocol (PP) analysis showed
that participants experienced an average reduction of 28.1%
of subcutaneous fat volume compared with placebo (p <
0.001).
In comparison, according to a study published in Aesthetic
Surgery Journal in 2012, abdominal liposuction removed an
average of 183mL of subcutaneous fat, indicating that
CBL-514's fat reduction efficacy could potentially surpass
traditional liposuction. Additionally, the study demonstrated a
favorable safety profile, with no severe adverse events (SAE)
reported.
Principal investigators emphasized
that CBL-514 achieved a fat reduction effect
comparable to liposuction, with significantly improved
safety, shorter treatment duration, and no required
downtime, positioning CBL-514 as a promising
alternative for non-invasive body contouring.
Caliway's CEO, Vivian Ling,
stated, "The acceptance of CBL-514's Phase 2
clinical data in ASJ once again affirms our research outcomes
and capabilities, reinforcing CBL-514's significant potential
in the localized fat reduction market. We will actively pursue
further publications of CBL-0204 Phase 2b results, to strengthen Caliway's academic and
commercial presence globally in the aesthetic medicine
industry."
With the global demand for non-invasive fat reduction solutions
continuing to rise, Caliway will accelerate subject
recruitment for two pivotal global Phase 3
studies for localized fat reduction in Q3
2025, actively expanding international collaborations, and
steadily progressing toward the goal of developing the world's
first FDA-approved injectable drug for large-area localized
fat reduction.
The study is expected to be officially published in ASJ in Q2
2025.
About ASJ
The Aesthetic Surgery Journal (ASJ) is a globally
recognized, peer-reviewed medical journal specializing in aesthetic
surgery and medicine. As the official publication of The Aesthetic
Society, ASJ serves as the leading English-language journal for
multiple major aesthetic, plastic, and reconstructive surgery
societies worldwide.
ASJ is currently ranked #1 among all aesthetic surgery journals
and #2 among all plastic surgery journals. It is dedicated
to advancing the science, artistry, and safety of aesthetic
surgery, making it a highly influential platform for groundbreaking
innovations in the field. (Source: The Aesthetic Society)
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.
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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