Caliway Biopharmaceuticals announced that its new drug CBL-514 for subcutaneous fat reduction (non-surgical local fat reduction) has been approved by FDA for phase 2b clinical trial. Its shares rose by 15% as per Taipei Exchange (ESB stocks), reaching the highest price of NT$195.5 since its stocked traded.
According to Vivian Ling, CEO of Caliway, that the CBL-514 injection is a new 505(b)(1) small molecule drug that induces apoptosis in fat cells and can be injected to precisely reduce fat in the treated area without causing necrosis or damage to other tissue cells, or causing side effects to the nervous system, cardiovascular system or respiratory center. It has been approved by FDA and in Australia and has completed a number of clinical trials for indications such as subcutaneous fat reduction (non-surgical topical fat reduction), treatment of the rare disease Sinusoidalgia and improvement of moderate/severe cellulite. Over the past 4 years, CBL-514 has completed a number of clinical trials in Australia and the US, which have shown excellent reproducibility in terms of efficacy and safety.
This FDA-approved phase 2b double-blind clinical trial is designed to evaluate the efficacy, safety and tolerability of CBL-514 injections for subcutaneous fat reduction in subjects with moderate or severe subcutaneous abdominal fat accumulation. The most significant aspect of this trial is that the efficacy of the Abdominal Subcutaneous Fat Reduction Scale (AFRS), the primary endpoint of the US FDA's pivotal phase III clinical trial for CBL-514, will be used as the primary endpoint for this trial, and MRI (magnetic resonance imaging) will be used to more accurately assess the amount of subcutaneous fat lost after treatment, in order to simulate and obtain the results of future pivotal clinical trials of the product. The pivotal study will be designed to simulate and qualify for a future pivotal phase 3 clinical trial (the "pivotal study").
Following FDA's suggestions for the pivotal phase III clinical endpoint AFRS and other product development for CBL-514 for subcutaneous fat reduction (non-surgical topical fat reduction) in 2021, the development and validation of the AFRS commenced immediately and was successfully completed in the fourth quarter of 2022. Other related phase III and NDA for CBL-514 product development have been completed or are in progress, and it is estimated that the application for which FDA suggested for pivotal study and regulatory requirements will be completed in the second quarter of 2024.
In order to reduce the risk, Caliway adopts a steady approach by requiring at least one double-blind phase II clinical trial to achieve at least one endpoint for efficacy and safety. In addition to that, the company is also taking this opportunity to highly simulate the efficacy assessment indicators and trial design for future pivotal trials and to obtain more sample and sufficient efficacy data to significantly enhance the likelihood of success of future pivotal trials. Therefore, if this trial is completed and the primary endpoint is met, CBL-514 will be initiated in 2024 for a global multi-country, multi-centre Phase III hub clinical trial for subcutaneous fat reduction.
