2023. 04

Caliway Biopharmaceuticals Announces Initiation of Subject Recruitment in a Phase 2-Stage 2 Study Evaluating the Efficacy of CBL-514 in Treating Moderate to Severe Cellulite

- The subject recruitment and treatment in CBL-0201EFP Phase 2-Stage 1 is completed.
- The preliminary data of CBL-0201EFP Phase 2-Stage 1 showed therapy potential and good safety and tolerability of CBL-514 for cellulite treatment.
- The CBL-0201EFP Phase 2-Stage 2 study is expected to be completed in Q4 2023, and the topline data will be anticipated in Q1 2024.

New Taipei City, April 24, 2023 - Caliway Biopharmaceuticals (Caliway), a biopharmaceutical company focusing on breakthrough medical aesthetics and inflammatory medicine discovery of small-molecule therapeutics, announced the initiation of subject recruitment in the CBL-0201EFP Phase 2-Stage 2 study. The study will evaluate the efficacy of CBL-514, Caliway's lead candidate therapy, in treating moderate to severe cellulite. Cellulite is a skin condition currently without effective and safe treatment.

Caliway has completed the subject recruitment and treatment in CBL-0201EFP Phase 2-Stage 1 study. With good safety and tolerability in the Phase 2-Stage 1 study, the Safety Review Committee (SRC) has approved the proceeding for the Phase 2-Stage 2 study and the treatment dosages. During the SRC meeting, the principal investigator (PI) further pointed out that the adverse events (AEs) of CBL-514 injection were very mild compared to other similar injection treatments, including collagenase clostridium histolyticum-aaes, deoxycholic acid, and Polidocanol. Additionally, the subjects in stage 1 were satisfied with the CBL-514 treatment results. The PI believes that the CBL-514 injection in cellulite treatment is promising.

Meanwhile, the Institutional Review Board (IRB) has also approved the CBL-0201EFP Phase 2-Stage 2 study protocol. The Phase 2-Stage 2 study is expected to be completed in Q4 2023, and the topline results are anticipated in Q1 2024.

About Cellulite

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. As many as 80 to 90% of women experience cellulite dimpling at some point in their life. The relief alterations of cellulite include depressions and raised areas. The depressions are caused by retraction of the skin by subcutaneous fibrous septa, while raised areas are projections of fat and subcutaneous structures to the skin surface.
The current treatment for cellulite includes non-invasive (medical devices and collagenase-related products) and invasive options. However, their efficacy remains limited as the current treatment options can only treat cellulite temporarily. Additionally, most products would cause significant side effects after administration, including severe bruising, pain, and pigmentation, making most patients reluctant to receive them. The clinical need for cellulite treatment remains unmet.
The global cellulite treatment market size in 2022 was $3.3 billion. With a compound annual growth rate (CAGR) of 7.8%, the global demand for cellulite treatment is estimated to expand to $5.2 billion in 2028.

About the CBL-0201EFP Phase 2 Study

The CBL-0201EFP study is a two-stage Phase 2 trial evaluating CBL-514's efficacy, safety, and tolerability in treating subjects with Edematous Fibrosclerotic Panniculopathy (EFP) cellulite. CBL-514 will be administrated by subcutaneous injection at the raised area of cellulite on both sides of the posterolateral thighs.
The CBL-0201EFP Phase 2-Stage 1 study (ClinicalTrial.gov, NCT05632926) is an open-label single ascending dose (SAD) trial that enrolled twelve subjects from two U.S. clinical trial centers to receive CBL-514 injections at one of three single doses (40mg, 60mg, and 80mg). After administration, the study evaluates a single CBL-514 injection's efficacy and safety profile at Week 1, Week 2, and Week 4.
The CBL-0201EFP Phase 2-Stage 2 study (ClinicalTrial.gov, NCT05836779) is an open-label trial that will enroll 20 subjects with moderate to severe cellulite. It will evaluate CBL-514's efficacy, safety, and tolerability with multi-administration, larger treated areas, and higher doses. All the subjects will receive CBL-514 treatment, and the treatment dose will base on the PI's evaluation of the ones' cellulite severity. Subjects will receive up to 320 mg per treatment session at intervals of approximately four weeks for up to a maximum of two treatments. After the last treatment, the efficacy and safety will be evaluated at follow-up visits in Week 4 and Week 8.

About CBL-514

CBL-514, a first-in-class small-molecule drug, is an injection lipolysis drug that can induce adipocyte apoptosis and lipolysis in vivo and in vitro studies and promote adipose cell apoptosis to reduce subcutaneous adiposity in targeted areas without causing any systematic side effects on the central nervous system, cardiovascular system, and respiratory system. Caliway's nonclinical studies showed that CBL-514  upregulates the apoptosis mediators caspase-3 and Bax/Bcl-2, and induces dose-dependent adipocyte apoptosis in vivo and in vitro.
Caliway is investigating multiple indications for CBL-514, including reducing subcutaneous fat (non-surgical fat reduction), Dercum's disease, cellulite, and lipoma treatment.

About Caliway Biopharmaceuticals

Caliway Biopharmaceuticals (Caliway) is a Taiwan-headquartered, clinical-stage biopharmaceutical company driven to breakthrough drug discovery of novel small-molecule therapeutics. Listed on the emerging stock market in Taiwan (TPEX6919), Caliway aims to become an innovative pharmaceutical leader in aesthetic medicine and inflammatory disease. 


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