Taiwan-based biopharmaceutical company Caliway Biopharmaceuticals has secured more than $100m in funding by issuing eight million of its new shares.
The company will use the funding to progress the Phase III clinical trial of its lead drug candidate, CBL-514, for fat reduction, as well as Phase III trials of other non-surgical subcutaneous fat reduction therapies.
CBL-514 is a small-molecule injectable lipolysis drug that is being analysed to cut down subcutaneous fat in therapy areas.
The drug is also being advanced in a Phase IIb CBL-0202DD trial against a placebo to treat Dercum’s disease.
Caliway Biopharmaceuticals CEO Vivian Ling said: “We are thrilled to see that CBL-0202 Phase II study results demonstrated that CBL-514 exerts promising efficacy on subcutaneous fat reduction, reducing more than 300mL of subcutaneous fat on average over the treated area compared with the placebo.
“Moreover, the CBL-0201DD Phase II study results showed that CBL-514 has a solid potential to become the first-in-class medicine to treat Dercum’s disease.
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“We found that 64.5% of painful lipomas show dimension reduction of more than 50% after CBL-514 treatment.”
Caliway Biopharmaceuticals has filed an application with the Australian Bellberry Human Research Ethics Committee (HREC) to begin a Phase III trial of CBL-514 for subcutaneous fat reduction.
The company also plans to submit an investigational new drug application (IND) to the US Food and Drug Administration (FDA), European Medicines Agency and various other regulators across the globe for the Phase III trial.
It recently submitted an IND application for a Phase IIb study of CBL-514 to treat Dercum’s disease to the FDA to assess the drug’s safety, efficacy and tolerance in treating Dercum’s disease.
In non-clinical studies, CBL-514 has proven that it can upregulate the apoptosis mediators caspase 3 and Bax/Bcl-2 ratio, causing dose-based in vivo and in vitro adipocyte apoptosis as a result.