Caliway Closes Oversubscribed Capital Raise and Secures Over $100M to Advance CBL-514 Pivotal Phase 3 Study in Subcutaneous Fat Reduction
The new funding will enable Caliway to advance the clinical development of its lead pipeline CBL-514, a small-molecule injectable drug that reduces subcutaneous fat in treatment areas. The use of proceeds includes multi-country, multi-center Pivotal Phase 3 studies for non-surgical subcutaneous fat reduction, and a CBL-514’s Phase 2b study (CBL-0202DD) for treating Dercum’s disease compared with placebo.
“We are thrilled to see that CBL-0202 Phase 2 study results demonstrated that CBL-514 exerts promising efficacy on subcutaneous fat reduction, reducing more than 300 mL of subcutaneous fat on average over the treated area compared with the placebo. 85.7% and 76.2% of participants lost at least 150mL and 200mL of subcutaneous fat in the treated area after receiving CBL-514 treatment(s).
Moreover, the CBL-0201DD Phase 2 study results showed that CBL-514 has a solid potential to become the first-in-class medicine to treat Dercum’s disease. We found that 64.5% of painful lipomas show dimension reduction of more than 50% after CBL-514 treatment.” said Vivian Ling, CEO of Caliway. “With the new funding, we look forward to pushing CBL-514 into its next clinical developmental milestones to fulfill the unmet medical needs for subcutaneous fat reduction and Dercum’s disease.”
The application of the CBL-514 Pivotal Phase 3 study (CBL-0301) for subcutaneous fat reduction has been submitted to Australian Bellberry HREC. Caliway will submit the Pivotal Phase 3 study IND to the U.S. FDA, EMA, and other countries’ regulatory authorities following up.
In addition, the IND application of CBL-514 Phase 2b study for Dercum’s disease was submitted to the U.S. FDA in December, 2023. The study will evaluate CBL-514’s efficacy, safety, and tolerance in treating Dercum’s disease compared with placebo.
About CBL-514CBL-514, a potentially first-in-class small-molecule drug, is an injection lipolysis drug that can induce adipocyte 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.