CBL-514 Phase 3 Subcutaneous Fat Reduction Study Approved

Caliway Biopharmaceuticals has received the green light from the Australian Bellberry Human Research Ethics Committee to begin a pivotal Phase 3 clinical trial for its drug candidate CBL-514, which is intended to reduce subcutaneous fat. The drug has shown promise as a non-invasive treatment for fat reduction, according to the Phase 2 study results. The upcoming Phase 3 trial will assess the drug's effectiveness in comparison to a placebo, using the Abdominal Fat Rating Scale (AFRS) and MRI as evaluation tools suggested by the U.S. FDA.

The Phase 3 study, known as CBL-0301, is set to be a large-scale, international, and multicenter clinical trial enrolling 300 participants. It will focus on the drug's efficacy, safety, and tolerability in reducing abdominal fat. The primary goal of the study is to measure the proportion of participants who show at least a one-grade improvement on the AFRS scale compared to those receiving a placebo.

CBL-514 is being developed as a first-in-class small molecule drug designed to induce fat cell death and break down fat in targeted areas without systemic side effects. The drug has demonstrated the ability to increase the activity of apoptosis mediators in preclinical studies, leading to fat cell apoptosis both in vivo and in vitro.

Currently, Caliway is conducting two Phase 2b studies in the U.S., Australia, and Canada, which are designed to mirror the Phase 3 study's protocols and efficacy assessment tools. Once preliminary results from one of these studies are available, Caliway plans to finalize and submit the Phase 3 study protocol.

Following the submission of the Phase 3 IND application to regulatory bodies such as the U.S. FDA and EMA, subject recruitment for the trial will commence upon receiving approval. Caliway is also preparing to submit an IND application for another Phase 3 study, CBL-0302, focusing on subcutaneous fat reduction.

The CBL-0301 study will be a randomized, double-blind, placebo-controlled trial. Participants with moderate to severe abdominal fat, as determined by the AFRS, will be given up to four injections of CBL-514 or a placebo every three weeks. The treatment dosage will be based on the degree of fat accumulation, with a maximum dose of 600 mg per session. The primary measure of effectiveness will be the percentage of participants showing at least a one-grade improvement on the AFRS at the second follow-up visit.

Current methods for reducing subcutaneous fat include invasive procedures like liposuction and abdominoplasty, as well as non-invasive treatments. However, many people are hesitant to undergo these procedures due to potential side effects and risks. The medical community continues to seek safer and more effective alternatives to meet the unmet needs in this area.

Caliway Biopharmaceuticals, headquartered in Taiwan, is a clinical-stage biopharmaceutical company focused on discovering innovative small-molecule therapeutics. The company is listed on Taiwan's emerging stock market and is committed to becoming a leader in the field of aesthetic medicine and other therapeutic areas.