AMI Pharm, a South Korean biotechnology company, has initiated a pivotal Phase 3 clinical trial for AYP-101, an innovative injectable drug designed to treat submental fat through a novel non-inflammatory mechanism. The 252-participant study, conducted across multiple sites in South Korea, represents a potential breakthrough in non-surgical fat reduction by addressing the pain and swelling limitations of current treatments.
Revolutionary Mechanism of Action
AYP-101 distinguishes itself from existing fat reduction therapies through its unique biological approach. While the only FDA-approved injectable drug for localized fat reduction relies on deoxycholic acid to destroy fat cells through necrosis—a process that triggers significant inflammation—AYP-101 selectively induces apoptosis, a natural form of programmed cell death that occurs without inflammatory response.
This non-cytolytic mechanism represents what the company describes as a "silent" process, designed to eliminate fat cells gently while minimizing the adverse effects commonly associated with current treatments, including pain, bruising, and prolonged swelling that often requires social downtime.
Strong Phase 2 Efficacy Results
The Phase 3 advancement follows successful completion of earlier clinical stages, with Phase 1 and Phase 2 trials meeting all primary safety and efficacy endpoints. In the Phase 2 study, over 70% of patients in the AYP-101 treatment group achieved at least a 1-grade improvement on the Evaluator-Reported Submental Fat Rating Scale (ER-SMFRS) in the per-protocol population.
The treatment demonstrated excellent tolerability and safety profiles, with minimal adverse events reported throughout the study period. These results provided the foundation for the current Phase 3 trial, which is scheduled for completion by the end of 2025.
Global Market Positioning
"AYP-101 represents the culmination of two decades of dedicated research aimed at creating a safe, effective, and globally competitive solution for localized fat reduction," said Ki-Taek Lee, CEO of AMI Pharm. "By leveraging a novel mechanism of action, we are pioneering the next generation of injectable drugs in aesthetic medicine."
The company positions AYP-101 as the world's first non-cytolytic injectable drug for localized fat reduction, targeting the multi-billion-dollar non-surgical aesthetics market. AMI Pharm has been actively presenting clinical data at international conferences, including the BIO International Convention and the IMCAS World Congress, while pursuing strategic partnerships for global commercialization.
Expanded Therapeutic Applications
Beyond the current focus on submental fat, AMI Pharm is developing a broader clinical strategy to expand AYP-101's indications. The company plans to investigate the drug's potential in treating cellulite, deep buccal (cheek) fat, and upper arm fat, addressing multiple high-demand areas in aesthetic medicine.
This expanded research and development approach reflects the company's long-term commitment to non-surgical body contouring innovation and its ambition to establish a leadership position in the global aesthetic medicine market.
