AMI Pharm Launches Phase 3 Clinical Trial for AYP-101
AMI Pharm has launched a critical Phase 3 clinical trial for AYP-101, an investigational injectable aimed at reducing submental fat. This trial will assess both the safety and effectiveness of the treatment, which targets localized fat deposits with fewer inflammatory side effects compared to existing options.
Current Treatment Options and AYP-101's Mechanism
Currently, the only FDA-approved injectable for submental fat removal is deoxycholic acid, which causes adipocyte destruction through necrosis. While effective, this process often leads to inflammation, resulting in discomfort, swelling, and bruising post-treatment. Conversely, AYP-101 works by inducing apoptosis, a controlled form of cell death that minimizes inflammatory responses, potentially enhancing patient comfort.
Study Details and Previous Trials
The multicenter, randomized Phase 3 study will involve 252 participants across South Korea and is anticipated to complete by late 2025. Previous Phase 1 and Phase 2 trials have demonstrated favorable safety profiles and promising efficacy. In the Phase 2 study, over 70% of participant...