Caliway Biopharmaceuticals Announces Initiation of Subject Recruitment in CBL-0204 Phase 2b Study Evaluating the Efficacy of CBL-514 in Abdominal Subcutaneous Fat Reduction

- Caliway has initiated the subject recruitment in CBL-0204 Phase 2b study.

- The study is expected to be completed in Q2 2024,and the topline results are anticipated in Q3 2024.

TAIPEI,May 31,2023 --Caliway Biopharmaceuticals,a biopharmaceutical company focusing on breakthrough medical aesthetics and inflammatory medicine discovery of small-molecule therapeutics,today announced the initiation of subject recruitment in CBL-0204 Phase 2b study. The study,approved by the U.S. FDA,will enroll 100 subjects in 14 clinical sites in the U.S. and Australia.

Caliway Biopharmaceuticals Announces Initiation of Subject Recruitment in CBL-0204 Phase 2b Study Evaluating the Efficacy of CBL-514 in Abdominal Subcutaneous Fat Reduction

CBL-0204 is a Phase 2b study evaluating the efficacy,safety and tolerability of CBL-514 injection,Caliway's leading candidate drug,in reducing abdominal subcutaneous fat. The study will enroll 100 adult subjects with mild,moderate,or severe abdominal subcutaneous fat as assessed by the abdominal fat rating scale (AFRS). The primary efficacy endpoint is the percentage of the subjects with at least one-grade improvement reported by the investigator assessing with the AFRS.

Currently,CBL-514 is the only product worldwide with similar efficacy as liposuction and the only non-surgical fat reduction drug for a large treatment area. The previously completed clinical trial results have demonstrated significant differences in CBL-514's efficacy in reducing subcutaneous fat in the treated area with excellent safety and tolerability profiles.

The CBL-0204 Phase 2b study is expected to be completed in Q2 2024. And the topline results are anticipated in Q3 2024. The Phase 3 pivotal study is expected to be applied in 2024.

About Fat Reduction

The current methods for fat reduction include non-invasive products and invasive surgery,such as liposuction and abdominal contour surgery. The efficacy of non-invasive products often takes more than twelve weeks to observe,and is generally poor with the limited treating body area. The potential moderate to severe side effects of non-invasive products include tissue necrosis,nerve damage,scar tissue fibrosis,and paradoxical adipose hyperplasia (PAH).

Though the efficacy of surgery is more significant compared to approved non-surgery local fat reduction products,the surgery still comes with severe side effects and a high risk of death.

According to the American Society of Plastic Surgeons' report,more than 60% of people are reluctant to undergo local fat reduction due to the fear of the side effects. The medical needs for local fat reduction remain unmet.

About the CBL-0204 Phase 2b Study

CBL-0204 is a multi-country,multicenter,randomized,placebo-controlled,Phase 2b study (ClinicalTrials.gov,NCT05736107) evaluating the efficacy,safety,and tolerability of CBL-514 injection in reducing subcutaneous fat. The study will enroll 100 adult subjects with mild,or severe abdominal subcutaneous fat as assessed by abdominal fat rating scale (AFRS). Each subject will receive up to four treatments of allocated CBL-514 or placebo administered subcutaneously to the abdomen,once every three weeks. The primary efficacy endpoint is the percentage of the subjects with at least one-grade improvement reported by the investigator using the AFRS.

About CBL-514

CBL-514,a first-in-class small-molecule drug,is an injection lipolysis drug that can induce adipocytes apoptosis and lipolysis to reduce subcutaneous adiposity in treatment areas in animal studies without causing any systematic side effects on the central nervous system,cardiovascular system,and respiratory system. Caliway's nonclinical studies showed that CBL-514 inhibits the cell survival kinase DYRK1b,upregulates the apoptosis mediators caspase 3 and Bax/Bcl-2 ratio,and then induces dose-dependent adipocyte apoptosis in vivo and in vitro.

Caliway is investigating multiple indications for CBL-514,including non-invasive fat reduction (reducing subcutaneous fat),Dercum's disease,cellulite,and lipoma treatment.

About Caliway Biopharmaceuticals

Caliway Biopharmaceuticals,based in Taiwan,is a clinical-stage biopharmaceutical company driven to breakthrough drug discovery of novel small-molecule therapeutics to help patients suffering from illness or life-threatening diseases. In Caliway,we aim to become an innovative pharmaceutical leader in medical aesthetics and inflammatory disease. For more information,please visit: www.Caliway.com.tw/en