Caliway Completes Recruitment for CBL-514 Cellulite Treatment Phase 2 Study

20 September 2023 | Wednesday | News


Caliway Biopharmaceuticals (Caliway), a biopharmaceutical company focusing on breakthrough medical aesthetics and inflammatory medicine discovery of small-molecule therapeutics, announced the completion of subject recruitment in the CBL-0201EFP Phase 2-stage 2 study.
Image Source : Public Domain

Image Source : Public Domain

The CBL-0201EFP Phase 2-stage 2 study is an open-label trial that will evaluate the efficacy, safety, and tolerability of CBL-514 in treating subjects with moderate to severe cellulite. The study actually enrolled a total of 23 subjects, all of whom will receive CBL-514 treatment. The efficacy and safety will be evaluated at follow-up visits at week 4 and week 12 after the last treatment. The topline results of the study are anticipated in Q2 2024.

 

The CBL-0201EFP study is a two-stage Phase 2 trial evaluating the efficacy, safety, and tolerability of CBL-514 in treating subjects with cellulite. CBL-514 will be administrated by subcutaneous injection at the treatment area of cellulite on both sides of the posterolateral thighs.

The CBL-0201EFP Phase 2-stage 2 study (NCT05836779) is an open-label trial that will evaluate the efficacy, safety, and tolerability of CBL-514 with up to two treatments, larger treated areas, and higher total doses, compared to the stage 1. All the subjects will receive CBL-514 treatment, and the treatment dose will be based on the PI's evaluation of the cellulite severity. Subjects will receive up to 320 mg of CBL-514 per treatment session at intervals of approximately four weeks. After the last treatment, the efficacy and safety will be evaluated at follow-up visits at V4(Week 4) and V5 (Week 12).

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