Caliway Completes FDA IND Filing for Phase 3b CBL-514 Trial of Abdominal Fat Reduction Drug
MT Newswires Live
Jun 04
Caliway Biopharmaceuticals (TPE:6919) completed its U.S. FDA IND submission for a Phase 3b long-term follow-up study of its abdominal subcutaneous fat reduction drug, according to a Wednesday Taiwan Exchange filing.
The study, dubbed CBL-0303, is designed to evaluate long-term safety and maintenance of efficacy of the drug called CBL-514, before the trail.
It is expected to enroll around 300 participants in the United States. The protocol also includes an optional re-treatment phase for eligible patients, the filing said.
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