Taiwanese biopharmaceutical company Caliway Biopharmaceuticals has announced that a Phase II trial of its CBL-514 injection lipolysis therapy met all its primary and secondary efficacy endpoints.
The CBL-514 multi-indication injection is intended to reduce subcutaneous adiposity by inducing adipocyte apoptosis.
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The open-label CBL-0201EFP study aimed to assess the injection’s tolerability, safety and efficacy in treating Edematous Fibrosclerotic Panniculopathy (EFP, Cellulite).
Caliway Biopharmaceuticals said the study demonstrated statistically and clinically significant efficacy of CBL-514 in improving cellulite severity with favourable safety and tolerance profiles.
It comprised a single ascending dose part in Stage I, followed by Stage 2’s single-arm design.
In the first stage, 12 participants received escalating doses of CBL-514, resulting in significant reductions in cellulite severity across all dosage groups. The highest dose group showed the most substantial improvements.
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By GlobalDataThe second stage involved 23 participants, who received up to two treatments. Results showed a mean reduction in cellulite severity, with more than 50% of participants experiencing at least one level of improvement.
Both the Principal Investigator and participants reported improved cellulite appearance in more than 95% of cases.
Adverse events were mostly mild to moderate injection site reactions, resolving within 28 days post-treatment.
Caliway Biopharmaceuticals said these results highlight CBL-514’s potential as an effective treatment, offering a new solution for reducing cellulite severity.
CBL-514 is also being evaluated for subcutaneous fat reduction and Dercum’s disease, having received fast track and orphan drug designations from the US Food and Drug Administration (FDA).
Current treatment options for cellulite include non-invasive methods such as medical devices and collagenase drugs, as well as invasive options.
These options are often limited and temporary in efficacy, with many also causing significant side effects once administered.
Earlier this year, Caliway Biopharmaceuticals received approval from the Australian Bellberry Human Research Ethics Committee to begin the Phase III CBL-0301 trial of CBL-514.
