NEW TAIPEI CITY, Jan. 23, 2024 /PRNewswire/ -- Caliway Biopharmaceuticals (Caliway) announces that Australian Bellberry HREC has approved Caliway's application to initiate CBL-514's Pivotal Phase 3 study (CBL-0301 Phase 3) for subcutaneous fat reduction.

"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 2 study," said Vivian Ling, CEO of Caliway. "The following CBL-514 Phase 3 study will further investigate its fat reduction efficacy compared with placebo with the U.S. FDA-suggested fat change assessment tool, Abdominal Fat Rating Scale (AFRS) and MRI."

The CBL-0301 Pivotal Phase 3 study is a multicountry and multicenter study that will recruit 300 subjects to evaluate CBL-514's efficacy, safety, and tolerability for reducing abdominal subcutaneous fat. The primary endpoint will be the percentage of subjects with at least 1-grade improvement on AFRS compared with placebo. The AFRS, developed by Caliway under the U.S. FDA recommendation, is a scale to assess fat accumulation severity and categorize subjects into 5 grades (1-5). The number indicated the severity of abdominal fat accumulation, with 1 indicating none/minimal and 5 indicating very severe.

Currently, there are two CBL-514 Phase 2b studies for subcutaneous fat reduction ongoing in the U.S., Australia, and Canada. To optimize the Phase 3 study protocol and to increase its successful rate of meeting endpoints, both Phase 2b studies were designed to simulate the Phase 3 study with the same efficacy assessment tools, AFRS and MRI. Caliway will submit the final Pivotal Phase 3 study protocol as soon as the preliminary result of the CBL-0204 Phase 2b study is announced.

Following up, Caliway will submit the CBL-0301 Phase 3 IND application to the U.S. FDA, EMA, and other countries' regulatory authorities. The subject recruitment will be initiated after receiving IND approval from the U.S. FDA. Caliway will also prepare to submit the IND application of another CBL-514's Pivotal CBL-0302 Phase 3 study for subcutaneous fat reduction.

About CBL-0301 Pivotal Phase 3 Study

The CBL-0301 Pivotal Phase 3 study is a multicountry and multicenter, randomized, double-blind, placebo-controlled study evaluating CBL-514 injection for reducing abdominal subcutaneous fat. CBL-514 will be administered via injection into the subcutaneous adipose layer on the abdomen.

The study will recruit a total of 300 subjects with moderate (Grade 3) to severe (Grade 4) abdominal subcutaneous fat reduction assessed by the Abdominal Fat Rating Scale (AFRS). The subjects will be randomized in a 2:1 ratio to receive up to 4 treatments of allocated CBL-514 or placebo administered on the abdomen once every 3 weeks, and complete 3 follow-up visits 4 weeks, 8 weeks, and 12 weeks after the last treatment. The treatment dose will depend on the level of subcutaneous fat accumulation on the participant's abdomen. The maximum dose is 600 mg per treatment.

The primary efficacy endpoint is the percentage of subjects with at least 1-grade AFRS improvement compared with placebo at the second follow-up. The secondary efficacy endpoints include the percentage of subjects with at least 2-grade AFRS improvement compared with placebo at each follow-up visit, and the number of treatments required to the first occurrence of 1-grade AFRS improvement.

About Subcutaneous Fat Reduction

The current subcutaneous fat reduction procedures include invasive surgery, such as liposuction and abdominoplasty, and non-invasive products. Studies have shown that liposuction can remove an average of 183.3mL of abdomen fat, yet it involves a lengthy procedure that is generally performed in an operating room and may also carry the risk of unfavorable outcomes and moderate to severe side effects. The efficacy of non-invasive procedures is generally less optimal with limited treatment areas and potential side effects, including tissue necrosis, nerve damage, and paradoxical adipose hyperplasia (PAH).

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

About CBL-514

CBL-514, a potentially 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 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 subcutaneous fat reduction, Dercum's disease, cellulite, and lipoma treatment.

About Caliway Biopharmaceuticals

Caliway Biopharmaceuticals (Caliway) is a Taiwan-headquartered, clinical-stage biopharmaceutical company driven to breakthrough drug discovery of novel small-molecule therapeutics. Listed on the emerging stock market in Taiwan (TPEX6919), Caliway aims to become an innovative pharmaceutical leader in aesthetic medicine and other diseases. For more information, please visit: www.Caliway.com.tw/en

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