Caliway's CBL-514 Achieved Better Efficacy than Liposuction, Reducing over 300mL of Subcutaneous Fat on Average in CBL-0202 Study

- CBL-0202 Phase 2 study results met all the primary and secondary endpoints.

- 69.9% and 60.9% of participants lost at least 150mL and 200mL of abdominal subcutaneous fat in the treated area after CBL-514 treatment.

- Compared with placebo,an average of 312.1mL of subcutaneous fat was reduced in the treated area after CBL-514 treatment.

- 42.9% of participants lost at least 150mL of subcutaneous fat in the treated area after only one CBL-514 treatment.

TAIPEI,Oct. 2,2023 -- Caliway Biopharmaceuticals (Caliway) announced the topline results of the CBL-0202 stage 2phase 2 study met all the primary and secondary efficacy endpoints compared with placebo in the ITT (Intent-to-treat) and PP (per-protocol) analysis population. "According to the study published in the Aesthetic Surgery Journal in 2012,liposuction could remove a mean of the subcutaneous fat volume of 183.3mL," said Vivian Ling,CEO of Caliway,"We are delighted to see that CBL-514 demonstrated the efficacy on subcutaneous fat reduction more effective than liposuction in the CBL-0202 stage 2 phase 2 study,reducing over 300mL of subcutaneous fat averagely."

Topline Results from the CBL-0202 Phase 2-stage 2 Study

Primary Endpoint

63.9% and 69.6% of participants in the CBL-514 group who lost at least 150mL of subcutaneous fat in the treated area at 4 weeks and 8 weeks after treatment; while in the placebo group,17.4% and 0.0% of participants who lost at least 150 mL of subcutaneous fat in the treated area at 4 weeks and 8 weeks after treatment. The percentage of participants who lost at least 150 mL of subcutaneous fat in the treated area at 4 weeks (p<0.001) and 8 weeks (p<0.00001) after CBL-514 treatment was significantly higher than the placebo group and achieved the primary endpoint.

Secondary Endpoints

58.3% and 60.9% of participants in the CBL-514 group who lost at least 200mL of subcutaneous fat in the treated area at 4 weeks and 8 weeks after treatment; while in the placebo group,8.7% and 0.0% of participants who lost at least 200 mL of subcutaneous fat in the treated area at 4 weeks and 8 weeks after treatment. The percentage of participants who lost at least 200 mL of subcutaneous fat in the treated area at 4 weeks (p< 0.0002) and 8 weeks (p< 0.0001) after CBL-514 treatment was significantly higher than the placebo group.

Compared with the placebo group,theLS mean (least square mean) difference of the subcutaneous fat volume change in the treated area at 4 weeks and 8 weeks after CBL-514 treatment were -312.08 mL (p<0.00001) and -276.83 mL (p<0.00005).

42.9% of participants lost at least 150mL of subcutaneous fat in the treated area after one CBL-514 treatment.

Overall,the safety and tolerability profiles of CBL-514 demonstrated in the study were favorable and consistent with previous clinical studies of CBL-514. Major TEAEs were ISRs (injection site reactions) that were mild and moderate,and most TEAEs were resolved before the end of the study visit.

About the CBL-0202 Stage 2 Study

The CBL-0202 stage 2 study(NCT04897412) is a randomized,single-blind,placebo-controlled phase 2 study to evaluate the efficacy,safety,and tolerability of CBL- 514 injection for abdominal subcutaneous fat reduction approved by the U.S. Food and Drug Administration (FDA) and Australian Therapeutic Goods Administration (TGA). CBL-514 will be administered via injection into the subcutaneous adipose layer on the abdomen. The trial randomized 76 participants across the U.S. and Australia in a 2:1 ratio to receive CBL-514 or a placebo. Each participant will receive up to 4 treatments of allocated CBL-514 or placebo administered on the abdomen once every 4 weeks and complete the two follow-up visits after the last treatment. The maximum dose is 600 mg per treatment,depending on the level of subcutaneous fat accumulation on the participant's abdomen.

The primary efficacy endpoint of the CBL-0202 -stage 2 phase 2 study is the percentage of participants who lost at least 150 mL of abdominal subcutaneous fat as measured by ultrasound at 4 weeks and 8 weeks follow-up visits after treatment compared with placebo. The critical secondary efficacy endpoints include the percentage of participants who lost at least 200 mL of abdominal subcutaneous fat as measured by ultrasound at 4 weeks and 8 weeks follow-up visits after treatment compared with placebo,and reduction of subcutaneous fat volume over the treated area as measured by ultrasound from Baseline to follow-up visits compared with placebo.

About Fat Reduction

The current methods for fat reduction include non-invasive products and invasive surgery,such as liposuction and abdominal contour surgery. The efficacies of non-invasive products often take more than twelve weeks to show,and are generally poor with the limited treatment 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 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 (Caliway),is a Taiwan-based,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