Caliway Biopharmaceuticals (Caliway) announced the topline results of the CBL-0202 stage 2 phase 2 study met all the primary and secondary efficacy endpoints compared with placebo in the IT (Intent-to-treat) and PP (per-protocol) analysis population. 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 150 mL 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 150mL of subcutaneous fat in The treated area at 4 weeks and8 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, the LS mean (least square mean) difference of the subcutaneous fat volume change in the treated area at 4week and 8 weeks after treatment were -312.08 mL (p; 42.9% of participants lost at least 150 mL of Subcutaneous fat in the treated areas 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.

The CBL-0202 stage2 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 volume change of the subcutaneous fat in the treatment.