Caliway Biopharmaceuticals announced it will present groundbreaking preclinical data on CBL-514's potential to prevent weight rebound when combined with GLP-1 receptor agonist therapies at the 2025 BIO International Convention in Boston. The presentation marks the first international disclosure of data addressing a critical unmet clinical need affecting the vast majority of patients discontinuing GLP-1 treatments.
Addressing Post-GLP-1 Weight Rebound Challenge
According to published studies cited by Caliway, only 10% of patients are able to maintain weight loss after stopping GLP-1 treatment, making post-discontinuation weight rebound a significant clinical concern as these therapies gain widespread global adoption. The company's preclinical data demonstrates that co-administration of CBL-514 with GLP-1 receptor agonists significantly reduced post-discontinuation body weight regain and fat replenishment rates.
"We believe post-weight-loss weight rebound is a promising unmet market need," said Vivian Ling, CEO of Caliway. "CBL-514 has the potential to serve as a complementary combination therapy with GLP-1 treatments — with GLP-1s driving weight reduction, and CBL-514 reshaping and maintaining outcomes through localized fat reduction, enhancing the overall treatment impact and long-term value."
Novel Mechanism of Action
CBL-514 works by directly targeting subcutaneous fat through selective induction of adipocyte apoptosis, addressing what Caliway describes as the root cause of weight rebound. This mechanism may serve as a complementary combination therapy to GLP-1s, pairing systemic weight loss with precise body contouring to maintain treatment outcomes.
The first-in-class injectable small-molecule drug is designed to reduce subcutaneous fat in targeted areas without causing systemic side effects on the central nervous system, cardiovascular system, and respiratory system. As of May 2025, Caliway has completed 10 clinical trials involving a total of 520 subjects, with all efficacy and safety endpoints met.
Development Timeline and Regulatory Strategy
Caliway plans to submit a Phase 2 IND application to the U.S. FDA for the weight rebound management indication in Q4 2025. The company is currently investigating multiple indications for CBL-514, including non-surgical fat reduction, moderate-to-severe cellulite, and the newly announced weight rebound management through combination therapy with GLP-1-based treatments.
BIO 2025 Presentation Details
Vice President April Yuan will deliver Caliway's corporate presentation on June 17 at the BIO International Convention, covering recent updates on CBL-514's development across multiple indications including subcutaneous fat reduction, cellulite, and Dercum's disease. The presentation will take place from 11:45 AM to 12:00 PM EDT in Room 154 at the Boston Convention & Exhibition Center.
The BIO International Convention attracts over 20,000 professionals and 5,000 companies from more than 80 countries, serving as a global platform for business development, innovation exchange, and investment in the biotechnology sector.
