Caliway cleared one stage of its Phase 2 Clinical Study in Weight Management

Announcement

Caliway, a leading biopharmaceutical company, proudly announced its submission of an Investigational New Drug (IND) application to the US FDA for its robust Phase 2 clinical study of its first-ever step in a vast localised fat reduction drug candidate. The candidate for CBL-514 for the weight management indication. This completion of the submission elevates the clinical development of CBL-514 in merger with GLP-1R agonist (GLP-1RA) therapies and further extends the presence of the company’s R&D sector in the universal weight management field.

About CBL-0201WR

The CBL-0201WR is a placebo-balanced, well-shuffled Phase 2 study to be organised at various centers in the United States. The study is predicted to register around 120 subjects with overweight or obesity with comorbidities. Furthermore, the study will assess the safety, tolerability and efficacy of CBL-514 in merger with Zepbound®. With the halt to CBL-514 and tirzepatide, the subjects will go through longitudinal follow-up to evaluate abdominal subcutaneous fat and body weight fluctuations, including body composition and fat mass based on parameters.

The efficacy endpoints involve fluctuation in body weight and abdominal subcutaneous fat volume calculated by MRI. The study will also gather the exact body composition data with the help of DEXA, consisting of visceral fat, muscle mass and body fat percentage. To mitigate the favouritism, the DEXA and MRI data will be learning and examined in a blinded way by CRO, a third party, prior to the incidental statistical analyses being conducted.

Trend of weight-loss drugs

Previous years have experienced that GLP-1RA weight loss drugs have peaked the adoption rate, which has fuelled growth in the vast weight management sector globally. The global focus is transitioning from succeeding in large volume weight reduction to achieving a greater fat reduction, body composition improvement, long-standing healthy and convincing weight management results, and post-discontinuation weight maintenance.

Recent GLP-1RA therapies initially achieved weight loss via appetite suppression. The clinical proofs show that while these therapies can exponentially cut the body weight, they mostly squeeze out the adipocyte size and do not alleviate adipocyte volume. Their impact on abdominal subcutaneous fat reduction is not much.

At the time of treatment, the deep appetite suppression prompts a prolonged adverse energy balance, provokes intrinsic memory and compensatory mechanisms of adipocytes to restore the size. Overall, the CBL-0201WR is engineered to identify these unmet needs, and the submission gets close to the concerned area to bring a specific promising solution for the same.