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NEW TAIPEI CITY - Caliway Biopharmaceuticals (TWSE:6919), a $67 million market cap biotech company with a FAIR financial health rating according to InvestingPro, announced Monday that the U.S. Food and Drug Administration has cleared its investigational drug CBL-514 to proceed with SUPREME-01, a pivotal Phase 3 clinical trial for reducing abdominal subcutaneous fat.
The company described CBL-514 as the first 505(b)(1) investigational drug to receive FDA clearance for Phase 3 trials with the proposed indication of "Reduction of Abdominal Subcutaneous Fat," rather than the more common aesthetic indication of "improvement in appearance." The company’s stock, currently trading at $9.17, has shown relatively low volatility this year with a beta of 0.49.
Subject recruitment is expected to begin in the third quarter of 2025 at 29 clinical sites across the United States and Canada. The study will involve 300 participants randomized to receive either CBL-514 or placebo.
The SUPREME-01 trial is designed as a randomized, double-blind, placebo-controlled study. Its primary endpoints include measuring abdominal fat volume change through MRI and assessing abdominal fat level change using a patient-reported rating scale.
Caliway also plans to submit regulatory applications for a second global pivotal Phase 3 study, SUPREME-02, in the U.S., Canada, and Australia later this year. The company expects to release topline results from SUPREME-01 between the fourth quarter of 2026 and first quarter of 2027.
Additionally, the company stated it intends to submit a Phase 2 IND application to the FDA in the fourth quarter of 2025 for combining CBL-514 with Tirzepatide, a GLP-1 receptor agonist used to treat obesity.
According to the press release, CBL-514 is a first-in-class small-molecule drug that induces adipocyte apoptosis to reduce subcutaneous fat in targeted areas without causing systemic side effects.
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