Caliway Biopharmaceuticals has announced successful results from its second Phase 2b clinical trial of CBL-514, positioning the world's first investigational drug for large-area localized fat reduction closer to potential market approval. The multi-center study, conducted across 15 sites in the U.S. and Canada, met all primary and secondary efficacy endpoints.
Significant Clinical Outcomes
The trial enrolled 173 participants with moderate to severe abdominal fat accumulation, as measured by the Abdominal Fat Rating Scale (AFRS). Results showed that 54.2% of participants receiving CBL-514 achieved at least 20% fat volume reduction four weeks after treatment, compared to 0% in the placebo group (p<0.00001).
Participants in the CBL-514 group experienced an average fat volume reduction of 166.6 mL, significantly outperforming both the placebo group, which showed a slight increase of 15.7 mL, and alternative formulations CBL-A1 and CBL-A2, which achieved reductions of 69.9 mL and 70.5 mL respectively.
Clinical Assessment and Patient Response
The treatment's effectiveness was further validated through both clinical and patient assessments. According to investigator evaluations, 75.7% of CBL-514 recipients achieved at least one grade improvement on the Clinician Reported-AFRS, compared to 27.5% in the placebo group. Patient self-assessments showed similar positive outcomes, with 73% reporting noticeable improvements.
Safety Profile and Treatment Protocol
The study implemented a structured treatment regimen, with participants receiving up to four subcutaneous abdominal injections at three-week intervals. Safety monitoring revealed a favorable profile with no drug-related serious adverse events or systematic side effects. The most common treatment-emergent adverse events were mild to moderate injection site reactions.
Mechanism of Action and Innovation
CBL-514 represents a novel approach to fat reduction, functioning as a lipolysis injectable that induces adipocyte apoptosis. The drug's mechanism involves upregulating the apoptosis mediator caspase 3 and Bax/Bcl-2 ratio, leading to targeted fat cell death without systemic effects on major body systems.
Future Development Plans
With seven completed clinical studies involving 474 participants, Caliway is preparing to advance CBL-514 to global Phase 3 trials. The company plans to initiate two pivotal studies in the second half of 2025, aiming to enroll approximately 600 participants. These trials will be crucial in establishing CBL-514 as a potential non-surgical alternative for localized fat reduction.
The development of CBL-514 addresses a significant market need for non-invasive fat reduction treatments, potentially offering an alternative to more invasive procedures like liposuction. The consistent results across multiple studies suggest promising potential for this first-in-class therapeutic approach.
