P3T for chin fat reduction injection ‘AYP-101’ approved

in Korea

Amipharm develops an incrementally modified aesthetic drug with improved polyene phosphatidylcholine (PPC) side effects

A Phase III trial for Amipharm's 'AYP-101', an injectable drug for submental fat reduction, will be conducted in Korea.

 

On the 16th, the Ministry of Food and Drug Safety approved a Phase III clinical trial to ‘evaluate the efficacy and safety of AYP-101 in reducing submental fat in adults with moderate-to-severe convexity or fullness associated with submental fat.

 

Amipharm had previously conducted a Phase II trial for the injection on 96 Koreans from August 2021 to June 2023 and will initiate the Phase III trial in Korea with the MFDS approval.

 

AYP-101 is an injectable for submental fat reduction that selectively induces fat cell apoptosis and lipolysis.

 

Its main ingredient is polyene phosphatidylcholine (PPC), a natural substance extracted from glycine max.

 

merr (soybeans) at high purity.

 

In 2018, Amipharm obtained a patent from the Korean Intellectual Property Office for "Composition and Manufacturing Method of Local Fat Reduction Injectable (AYP-101) without Pain, Edema and Side Effects.

 

If commercialized, Amipharm expects AYP-101 will become the first new incrementally modified drug to be developed in Korea in the aesthetic field.

 

AYP-101’s composition improves the disadvantages of existing PPC injections, which cause pain and swelling through a mechanism of action that brings about cell necrosis.

 

PPC injections have previously been approved for cell membrane binding and regeneration in areas such as liver disease and dementia as ‘Lipobin Inj,’ but have been used off-label as lipolysis injections.

 

Current treatment options for submental fat, also known as a double chin, are limited.

 

Existing methods include off-label, mesotherapy cocktail injections performed under general or local anesthesia and surgical liposuction performed under general anesthesia.

 

AYP-101 is expected to help expand the therapeutic area for the injection to patients who are interested in the non-surgical injectable method of localized fat reduction.

 

Meanwhile, AMI Investment, an investment company established through a 6:4 joint venture between KPM Tech and Telcon, invested KRW 10 billion and acquired 810,000 shares (24.2% stake) of AmiPharm, and became the second largest shareholder.

 

Amipharm holds a patent for 'Composition and Manufacturing Method for Injectable Drug Containing PPC without deoxycholic acid sodium’ that it obtained in Korea in 2014 and a patent for 'Composition and Manufacturing Method for Fat Decomposition Substance that contain PPC' in the United States in 2015.