Caliway Biopharmaceuticals has officially announced that its CBL-514’s second Phase 2b clinical study (CBL-0205), which was conducted at different 15 sites across the U.S. and Canada, successfully met primary and all critical secondary efficacy endpoints.
Expanding upon CBL-514, it is a lipolysis injectable which can effectively induce adipocyte apoptosis and lipolysis to reduce subcutaneous adiposity in treatment areas without causing any systematic side effects on the central nervous system, cardiovascular system, and respiratory system.
According to certain reports, CBL-0205 Phase 2b was essentially a multi-center, double-masking (Participant and Outcomes Assessor), randomized, placebo-controlled clinical study approved by the U.S. FDA and Health Canada.
More on the same would reveal how this also was the largest CBL-514 study till date. You see, it would go on to enroll 173 participants with moderate (Grade 3) or severe (Grade 4) abdominal fat accumulation, as assessed by the Abdominal Fat Rating Scale (AFRS). Each participant here received up to 4 treatments of the allocated study drug administered subcutaneously to the abdomen, once every 3 weeks.
The prescription was followed by four and eight weeks of efficacy and safety follow-up visits after the final treatment.
Talk about the results on a slightly deeper level, we begin from the primary endpoint, where MRI data showed that 54.2% of participants in the CBL-514 group achieved at least 20% fat volume reduction at four weeks after the final treatment. For better understanding, the placebo group could only manage 0% (p<0.00001).
Turning our attention towards the secondary endpoints, they had 54.2% of participants in the CBL-514 group achieving at least 20% fat volume reduction at four weeks after the final treatment, significantly outperforming compared to 17.4% in the CBL-A1 group (p<0.02) and 7.7% in the CBL-A2 group (p<0.0005).
Next up, we must dig into how the CBL-514 group participants achieved an average of 166.6 mL subcutaneous fat volume reduction four weeks after the final treatment. This was significantly greater than the 15.7 mL increase in fat volume observed throughout the placebo group (p<0.00001).
Not just that, when the researchers pitted CBL-514 against CBL-A1 and CBL-A2 groups, the former markedly showed a higher absolute reduction (CBL-514: 166.6 mL vs. CBL-A1: 69.9 mL, p<0.00005; CBL-514 vs. CBL-A2: 70.5 mL, p<0.00005).
Another detail worth a mention here is rooted in the CBL-514 group participants demonstrating a mean fat volume reduction of 22.4% four weeks after the final treatment. In the placebo group, the increase was of a meager 1.8%.
As for subcutaneous fat volume, it saw CBL-514 showcasing a significantly higher percentage reduction in subcutaneous fat volume (CBL-514: 22.4% vs. CBL-A1:10.5%, p<0.0002; CBL-514 vs. CBL-A2: 11.7%, p<0.0005).
Apart from that, we must also mention that, four weeks after the final treatment, 75.7% of participants in the CBL-514 group successfully achieved at least 1 grade CR-AFRS improvement as assessed by investigators, compared to 27.5% in the placebo group (p< 0.00005).
Quite similar to that, 73.0% of participants in the CBL-514 group achieved at least 1 grade PR-AFRS improvement, as assessed by participants. The same was significantly higher than 20.0% in the placebo group (p<0.00002).
If we talk about Grade 3 (moderate) or Grade 4 (severe) participants, liposuction procedure was found to typically improve only 1-grade AFRS. These results reinforce the claim that CBL-514 effectively can reduce subcutaneous fat and delivers noticeable improvements within four weeks, as reported by physicians and participants.
All in all, the safety and tolerability profiles of CBL-514 were deemed largely favorable and consistent with previous clinical studies of CBL-514.
Among other things, we ought to mention how, up until now, Caliway has completed 7 CBL-514 clinical studies for localized fat reduction, covering 474 participants, with each study meeting its primary efficacy endpoint. This translates to product’s strong efficacy and safety profile. For future, the company plans on initiating subject recruitment for two pivotal global Phase 3 studies in the second half of 2025. These studies will oversee a total enrollment of approximately 600 participants.
