#South Korea #Seoul #fat reduction #AMI Pharm #AYP-101

AMI Pharm Unveils AYP-101 in Phase 3 Trials

AMI Pharm, a biotechnology company focused on aesthetic and therapeutic innovations, has made a major breakthrough for its main candidate, AYP-101. Recently, the company announced that it has progressed AYP-101 into the crucial Phase 3 clinical trials aimed at treating submental fat, commonly referred to as the "double chin."

Introduction to AYP-101

AYP-101 is designed to provide effective fat reduction while minimizing pain, inflammation, and social downtime, which are often associated with currently available injectable medications. This innovative drug represents a potential paradigm shift in the multi-billion dollar market of non-surgical aesthetics. It employs a unique biological mechanism distinct from traditional fat reduction methods.

Current Standards in Injectable Therapies

The only FDA-approved injectable drug for localized fat reduction currently on the market is based on deoxycholic acid, which destroys fat cells through a process known as necrosis. While effective, this cytolytic method often causes significant inflammation, resulting in pain, bruising, and prolonged swelling in patients. The need for a less traumatic alternative has never been greater.

In stark contrast, AYP-101 promotes the selective apoptosis, a natural and controlled form of programmed cell death that occurs without triggering inflammation. This silent mechanism aims to eliminate fat gently, offering patients a safer and more tolerable experience compared to traditional injectable options.

Phase 3 Trials Following Promising Results

Currently, AYP-101 is being evaluated in a Phase 3 trial involving 252 participants in South Korea, with an anticipated conclusion by late 2025. This development follows encouraging results from the earlier Phase 1 and Phase 2 trials, where all major safety and efficacy criteria were met. Notably, more than 70 percent of patients in Phase 2 showed at least a one-grade improvement on the Evaluator-Reported Submental Fat Rating Scale (ER-SMFRS) within the Per Protocol population, indicating excellent safety and tolerability.

"AYP-101 is the culmination of two decades of dedicated research and development," stated Ki-Taek Lee, CEO of AMI Pharm. "We believe it to be the world’s first non-cytolytic injectable drug for localized fat reduction, and we are confident it will spearhead the next wave of innovation in aesthetic medicine."

Global Expansion and Broader Indications Ahead

AMI Pharm is actively presenting AYP-101 at international congresses such as the International BIO Convention and the World IMCAS Congress, while also seeking strategic partnerships for its global rollout. The company has plans to broaden its clinical focus to include treatments for other cosmetic concerns such as cellulite, malar fat (buccal fat), and upper arm fat. This ambitious objective underlines AMI Pharm's long-term commitment to innovating non-surgical body contouring solutions.

As AYP-101 continues its promising journey through clinical trials, industry experts and potential patients alike will be watching closely, anticipating a new era in fat reduction therapies that prioritize comfort and efficacy.