Caliway Biopharmaceuticals announced that the CBL-0201EFP Phase 2-Stage 1 results demonstrated the significant cellulite severity improvement with a single CBL-514 treatment. Cellulite is a skin condition currently without effective and safe treatment. CBL-514, Caliway's lead candidate drug, is a non-surgical lipolytic injection that can reduce local fat precisely by inducing adipocyte apoptosis and lipolysis.

The CBL-0201E FP Phase 2-Stage 1 data demonstrated that CBL-514 is the first and only non-invasive product that can significantly improve 1 level of cellulite severity two weeks after a single treatment. Phase 2 Study of CBL-514 in Treating Cellulite: CBL-0201ETP is a U.S. FDA-approved, two-stage Phase 2 study evaluating the efficacy, safety, and tolerability of CBL-514 injection in treating subjects with moderate to severe Edematous Fibrosclerotic Panniculopathy (EFP), cellulite. The first stage of CBL-0201EFS is an open-label, single ascending dose (SAD) study aimed to evaluate CBL-514's efficacy and determine the optimized dose for cellulite treatment.

The study enrolled twelve subjects in three potential escalating CBL-514 dose groups, including 40 mg, 60 mg, and 80 mg. Each subject was sequentially assigned to receive one course of allocated CBL-514 doseadministrated subcutaneously on both sides of the posterolateral thighs. The efficacy and safety of CBL-514 were evaluated at Week 1, Week 2, and Week 4 post-administration.

The primary efficacy endpoint was evaluated by the total score change in modified Hexsel Cellulite Severity Scale (HCSS) compared to the baseline. The secondary efficacy endpoint was evaluated by the percentage of thighs with at least 1-level improvement in modified HCSS. Preliminary Efficacy Data Summary of CBL-0201 Efficacy Data Summary of CBL-514 Phase 2-Stage 1. The efficacy data are composed of all dosing groups in the stage 1 study.

Each group includes four subjects with both thighs administrated with CBL-514 injection.