Caliway Biopharmaceuticals has completed subject recruitment in a Phase II-stage 2 study investigating its candidate treatment for cellulite.

The open-label trial, single-arm study (NCT05836779) will evaluate the efficacy, safety and tolerability of CBL-514 in treating patients with moderate to severe forms of the condition.

Caliway stated that it enrolled a total of 23 subjects who will receive up to 320mg per treatment session every four weeks. CBL-514 will be administered subcutaneously at the area of cellulite over a maximum of two treatment sessions.

Patients will be assessed at follow-up visits after four weeks and twelve weeks. The primary outcome is the measurement of cellulite severity scale from baseline after at least one course of the treatment.

Caliway expects topline results from the study in Q2 2024. The single-arm stage 2 portion of the Phase IIa study follows a single-ascending dose part in stage 1.

In June 2023, the company announced positive data from the stage 1 part of the study. Caliway reported that 87.5% of thighs achieved at least 1-level improvement in cellulite severity two weeks after treatment.

Cellulite is a condition characterised by dimpled skin, occurring on the thighs and buttocks. Caliway states that current therapies are limited in that they only treat cellulitis temporarily.

CBL-514 is a lipolytic injection that induces adipocyte apoptosis and lipoloysis, thereby reducing local fat. Caliway is also putting the candidate through trials in treating Dercum’s disease and lipomas.