- CBL-514 is the first product to treat cellulite at the
raised areas.
- Currently, there is no effective and safe cellulite
treatment on the market. The global market for cellulite treatment
is estimated to expand to $7.37
billion in 2034.
- CBL-0201EFP Phase 2 study demonstrated CBL-514 statistically
significant efficacy in reducing cellulite severity scores at 4 and
12 weeks after treatment.
- Over 50% of participants
experienced at least one level of improvement in cellulite severity
12 weeks after the final CBL-514 treatment evaluating with the
modified Hexsel Cellulite Severity Scale among 4 levels of
severity.
- CBL-514 is under development for multiple indications,
including Cellulite, Local Fat Reduction (currently in Phase
2b), and Durum's disease (currently
in Phase 2), which brought Caliway the Fast Track Designation and
the Orphan Drug Designation by the FDA in Feb. 2024.
NEW TAIPEI CITY, April 25,
2024 /PRNewswire/ -- Caliway Biopharmaceuticals
(Caliway) today announced the
topline results of the CBL-0201EFP Phase 2 study, which met all the
primary and secondary efficacy endpoints in the ITT
(Intent-to-treat) and PP (per-protocol) analysis population,
demonstrating CBL-514's statistically and clinically significant
efficacy in improving cellulite severity with favorable safety and
tolerance profiles.
CBL-514, Caliway's lead pipeline, is a multi-indication
lipolysis injection that can reduce subcutaneous adiposity by
inducing adipocyte apoptosis. Among all the current cellulite
treatment products, CBL-514 is the first and only product to treat
cellulite in the raised areas.
Apart from cellulite treatment, CBL-514 is also under Phase 2
study for subcutaneous fat reduction and Dercum's disease.
Moreover, the U.S. FDA granted CBL-514 Fast Track Designation and
Orphan Drug Designation based on the CBL-0201DD Phase 2 study
results for Dercum's disease in February
2024.
CBL-0201EFP Phase 2-stage 1 Topline Results: Significant
Reductions in Cellulite Severity Across Three Dosage Groups
CBL-0201EFP Phase 2 study is an
open-labeled study to evaluate the safety, tolerability, and
efficacy of CBL-514 injection for the treatment of Edematous
Fibrosclerotic Panniculopathy (EFP, cellulite). The efficacy was
assessed using the modified Hexsel Cellulite Severity Scale
(Modified HCSS), with the highest score (9) indicating the most
severe cellulite severity and the lowest score (0) indicating no
cellulite. The severity level of cellulite will be scored as mild
(1-3), moderate (4-6), or severe (7-9), which will be determined by
the total scores.
In the CBL-0201EFP Phase 2-stage 1 dose-finding study, a total
of 12 participants were enrolled in 3 sequential escalating CBL-514
dose groups, 40mg, 60mg, and 80mg, to receive 1 CBL-514 treatment
administered on both sides of the posterolateral thighs.
The statistical analysis revealed significant reductions in
cellulite severity across three dosage groups. Follow-up
assessments at 2 and 4 weeks post single treatment on both thighs
showed statistically significant improvements in cellulite severity
for all dosage groups, with the high-dose group of 80 mg showing
the most promising efficacy, reducing cellulite severity score
(mean±SD) of -2.0±0.9 points (p= 0.00049,95%CI: -2.77, -1.23) and
-2.6±1.5 (p= 0.00169,95%CI: -3.88, -1.37) at 2 and 4 weeks after
treatment.
CBL-0201EFP Phase 2-stage 2 Topline Results: Over 50% of
Participants Demonstrated at least One
Level of Improvement Among 4 Cellulite Severity
Levels
In the CBL-0201EFP Phase 2-stage 2
study is a single-arm study, a total of 23 participants were
enrolled to receive up to 2 CBL-514 treatments based on cellulite
severity on the thighs, with a maximum single dose not exceeding
320 mg administered at 4-week intervals.
The baseline of participants' average cellulite severity score
(mean±SD) is 6.5 ± 1.0 points. Four weeks after the final CBL-514
treatment, using Modified HCSS score of 1 ~9 in 4 severity levels,
there was a reduction in cellulite severity with a mean change of
-1.3 ± 1.3 points (p < 0.00001, 95% CI: -1.70, -0.90),
demonstrating CBL-514's statically significant efficacy in
cellulite severity improvement at both 4 weeks (p < 0.00001) and
12 weeks (p < 0.00001) after CBL-514 treatment. Moreover, over
50% of participants experienced at least one level of improvement
in cellulite severity at the 12 weeks after the final CBL-514
treatment.
In addition to the primary efficacy endpoint, a secondary
efficacy endpoint assessed by the Global Aesthetic Improvement
Scale (GAIS) demonstrated notable improvements in cellulite.
Following the final treatment, both the Principal Investigator (PI)
and participants assessed over 95% of individuals as having
improved cellulite appearance at the four-week mark.
The safety and tolerability profiles of CBL-514 demonstrated in
both stages of the study were favorable and consistent with
previous clinical studies of CBL-514. Most adverse events were mild
to moderate injection site reactions, including injection site
bruising, pain, swelling, and warmth, and were resolved within 28
days post-treatment.
These findings underscore the potential of CBL-514 as a highly
effective treatment option for reducing cellulite severity,
offering renewed confidence and satisfaction to those affected by
this common cosmetic concern.
Following up, Caliway will further develop the cellulite
severity scale for future CBL-514 clinical studies to evaluate
cellulite improvement efficacy based on the U.S. FDA's
instruction.
About Cellulite (Edematous Fibrosclerotic Panniculopathy,
EFP)
Cellulite is characterized by the nonpathological appearance of
the dimpled skin surface (likened to orange peel, cottage cheese,
or mattress appearance), which occurs on the thighs and buttocks.
The relief alterations of cellulite include depressions and raised
areas. The depressions are caused by skin retraction by
subcutaneous fibrous septa, while raised areas are projections of
fat and subcutaneous structures to the skin surface. According to
the American Society of Plastic Surgeons (ASPS) report, around 80
to 90% of women experience cellulite dimpling.
The current treatment for cellulite includes non-invasive
(medical devices and collagenase drug) and invasive options.
However, their efficacy remains limited and temporary.
Additionally, most products would cause significant side effects
after administration, including severe bruising, pain, and
hyperpigmentation, making most patients reluctant to receive them.
The clinical need for cellulite treatment remains unmet. The global
market for cellulite treatment is estimated to expand to
$7.37 billion in 2034.
About the CBL-0201EFP Phase 2 Study
CBL-0201EFP Phase 2 study is an open-labeled study assessing the
efficacy and safety of CBL-514 in participants with Edematous
Fibrosclerotic Panniculopathy (EFP) cellulite. The study has an
integrated design consisting of a single ascending dose (SAD) part
in Stage 1 followed by a single-arm design in Stage 2.
The Stage 1 study (clinicaltrial.gov ID: NCT05632926) included a
total of 12 participants enrolled in 3 sequential escalating
CBL-514 dose groups, 40mg, 60mg, and 80mg. Eligible participants
will be sequentially assigned to receive 1 course of allocated
CBL-514 dose administered by subcutaneous injection on both sides
of the posterolateral thighs.
The Stage 2 study (clinicaltrial.gov ID: NCT05836779) included a
total of 23 participants enrolled in 1 selected CBL-514 dose.
Eligible participants will be sequentially assigned to receive up
to 2 courses of allocated CBL-514 dose administered by subcutaneous
injection on both sides of the posterolateral thighs.
About CBL-514
CBL-514, a potentially first-in-class small-molecule drug, is a
lipolysis injection that can induce adipocyte apoptosis and
lipolysis to reduce subcutaneous adiposity in treatment areas in
animal studies without causing any systematic side effects on the
central nervous system and cardiovascular system, and respiratory
system. Caliway's preclinical studies showed that CBL-514
upregulates the apoptosis mediators caspase 3 and Bax/Bcl-2 ratio,
and then induces dose-dependent adipocyte apoptosis in vivo and in
vitro.
Caliway is investigating multiple indications for CBL-514,
including non-invasive subcutaneous fat reduction, Dercum's
disease, cellulite, and lipoma treatment.
About Caliway Biopharmaceuticals
Caliway Biopharmaceuticals (Caliway) is a Taiwan-headquartered, clinical-stage
biopharmaceutical company driven by the discovery of breakthrough
small-molecule therapeutics with a focus on medical aesthetics and
inflammatory disease.
Listed on the emerging stock market in Taiwan (TPEX6919), Caliway aims to become an
innovative pharmaceutical leader in aesthetic medicine and other
diseases. For more information, please visit:
http://www.Caliway.com.tw/en
Disclaimer
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forward-looking statements. The forward-looking information
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For additional contact:
info@caliway.com.tw
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