Taiwanese biopharmaceutical company Caliway Biopharmaceuticals announced that a Phase II trial of its injectable lipolysis treatment CBL-514 met all of its primary and secondary efficacy endpoints.
The multi-indication CBL-514 injection is intended to reduce subcutaneous obesity by inducing adipocyte apoptosis.
The open-label study CBL-0201EFP aimed to evaluate the tolerability, safety and efficacy of the injection in the treatment of edematous fibrosclerotic pannicopathy (EFP, cellulitis).
Caliway Biopharmaceuticals said the study demonstrated statistically and clinically significant efficacy of CBL-514 in improving the severity of cellulite with favorable safety and tolerability profiles.
It consisted of a single escalating dose arm in Stage I, followed by the Stage 2 single-arm design.
In the first phase, 12 participants received escalating doses of CBL-514, resulting in significant reductions in cellulitis severity in all dose groups. The highest dose group showed the most substantial improvements.
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The second stage involved 23 participants, who received up to two treatments. The results showed an average reduction in the severity of cellulite, with more than 50% of participants experiencing at least some level of improvement.
Both the principal investigator and participants reported an improved appearance of cellulite in more than 95% of cases.
Adverse events were mainly mild to moderate injection site reactions, which resolved within 28 days of treatment.
Caliway Biopharmaceuticals said these results highlight the potential of CBL-514 as an effective treatment, offering a new solution to reduce the severity of cellulite.
CBL-514 is also being evaluated for the reduction of subcutaneous fat 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 medications, as well as invasive options.
These options are often limited and temporary in effectiveness, with many also causing significant side effects once administered.
Earlier this year, Caliway Biopharmaceuticals received approval from the Australian Human Research Ethics Committee for Bellberry to begin the Phase III CBL-0301 trial of CBL-514.
