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Caliway Biopharma Submits Amended Protocol for Cellulite, Dercum's Drug

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Caliway Biopharmaceuticals (TPE:6919) submitted an amended protocol for CBL-514, an investigational drug being developed to reduce subcutaneous fat and treat moderate-to-severe cellulite and Dercum's disease, to the US FDA and Health Canada.

The amendment covers the CBL-0302 pivotal Phase 3 trial, which will evaluate CBL-514 for improving the appearance of abdominal subcutaneous fat in about 320 participants, according to a Monday Taiwan Exchange filing.

The company submitted the amended protocol after FDA recommendations, it said.

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