AMI Pharm’s double chin treatment enters phase 3 clinical trial

SEOUL - South Korean biotechnology company AMI Pharm (market capitalization: $101.7 million) announced Monday that its injectable drug candidate AYP-101 has entered Phase 3 clinical trials for treating submental fat, commonly known as "double chin." Despite challenging market conditions, the company maintains impressive gross profit margins of 55.47%, according to InvestingPro data.

The ongoing trial involves 252 participants across multiple sites in South Korea and is expected to be completed by the end of 2025, according to a company press release.

AYP-101 utilizes a different biological mechanism than currently available treatments. While the only FDA-approved drug for localized fat reduction works through deoxycholic acid that destroys fat cells through necrosis, AYP-101 is designed to eliminate fat through apoptosis, a controlled form of programmed cell death.

The company claims this approach could reduce side effects such as pain, bruising and swelling that are associated with existing treatments.

The Phase 3 trial follows Phase 1 and 2 trials that met safety and efficacy endpoints. In the Phase 2 trial, over 70% of patients in the AYP-101 group achieved at least a one-grade improvement on the Evaluator-Reported Submental Fat Rating Scale in the per-protocol population.

"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.

The company stated it is preparing for global commercialization and exploring potential applications for the drug in other areas, including cellulite, cheek fat, and upper arm fat reduction. For comprehensive analysis of AMI Pharm’s financial health and growth prospects, including additional ProTips and detailed metrics, visit InvestingPro, where you’ll find expert insights and in-depth research reports covering 1,400+ US equities.

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