Caliway Biopharmaceuticals has received approval from the Australian Bellberry Human Research Ethics Committee to commence the CBL-0301 pivotal Phase III clinical trial of its CBL-514 injection lipolysis therapy for subcutaneous fat reduction.

A small-molecule drug, CBL-514 can potentially elicit apoptosis and lipolysis in adipocytes to cut down subcutaneous adiposity in the areas of treatment.

The placebo-controlled, multicounty, multicentre, double-blind, randomised trial aims to enrol 300 subjects.

It is designed to assess the safety, efficacy and tolerability of CBL-514 versus a placebo in lowering abdominal subcutaneous fat.

The trial participants will include those with moderate to severe abdominal subcutaneous fat.

In this trial, the drug doses will be injected directly into the subcutaneous adipose layer of the abdomen once every three weeks.

The percentage of participants achieving a minimum of a one-grade improvement on the Abdominal Fat Rating Scale (AFRS) versus a placebo at the second follow-up will be the trial’s primary efficacy endpoint.

Secondary endpoints will include the percentage of people with a minimum of a two-grade AFRS improvement at each follow-up, as well as the number of treatments needed to achieve a one-grade AFRS improvement.

Caliway CEO Vivian Ling said: “We are all delighted to see CBL-514 showing its potential to become the new, promising, non-invasive fat reduction treatment in the previous Phase II study.

“The following CBL-514 Phase III study will further investigate its fat reduction efficacy, compared with a placebo, with the US FDA [US Food and Drug Administration]-suggested fat change assessment tool, AFRS, and MRI [magnetic resonance imaging].”

In addition to the upcoming Phase III study, Caliway is presently conducting two Phase IIb trials of CBL-514 in the US, Australia and Canada.

These studies use the same AFRS and MRI efficacy assessment tools for optimising the Phase III trial protocol and enhancing the likelihood of meeting endpoints.

Caliway plans to submit the final protocol for the Phase III trial after initial data from the CBL-0204 Phase IIb study is reported.

Following this, the company will file a Phase III Investigational New Drug application with the FDA, European Medicines Agency and other regulatory bodies.