AMI Pharm's AYP-101 Shows Promise in Phase 2 Trial, Signaling a Breakthrough in Nonsurgical Fat Reduction

• AMI Pharm's 'AYP-101' Sets to Become a New Leader in Nonsurgical Fat Reduction with Phase 2 Trial Success
• 'AYP-101,' a Promising Nonsurgical Solution, Has Its Clinical Results Published in Clinical Therapeutics
• 'AYP-101' Demonstrates Superior Safety and Efficacy, Poised to Change the Paradigm of Submental Fat Reduction

SEOUL, South Korea, Sept. 1, 2025 /PRNewswire/ -- AMI Pharm's novel injectable drug, AYP-101, has shown promising results in a Phase 2 clinical trial for the reduction of submental fat (SMF), commonly known as a double chin. The clinical data from the trial was recently published in Clinical Therapeutics, a leading journal for drug and therapy development. This publication marks a significant milestone for AYP-101 and highlights its potential as a safe and effective nonsurgical treatment option. The study evaluated the efficacy and safety of AYP-101 at two different concentrations. The results showed that the 25 mg/mL concentration, administered every two weeks for six sessions, led to statistically significant and clinically meaningful reductions in moderate to severe SMF.

Demonstrated Efficacy and Safety

The Phase 2 study enrolled 96 participants and demonstrated strong results. At four weeks after the final treatment, 69.70% of participants in the 25 mg/mL treatment group achieved at least a one-grade improvement in both the Evaluator-Reported and Subject-Reported Submental Fat Rating Scales (ER-SMFRS and SR-SMFRS). This was a statistically significant improvement compared to the 22.58% response rate in the placebo group. The trial data also highlighted AYP-101's favorable safety and tolerability profile. The drug is uniquely designed to eliminate fat through a process called apoptosis while minimizing damage to surrounding tissues. The study found that AYP-101 required fewer injection points and produced a lower incidence of post-injection swelling and paresthesia compared to what is typically reported for Deoxycholic Acid (DCA).

A Leader in the Growing Aesthetics Market

With the global demand for nonsurgical fat reduction solutions on the rise, AMI Pharm is actively pursuing the next phase of development. According to Ki-Taek Lee, CEO of AMI Pharm, the publication of the Phase 2 data "reaffirms our research capabilities and demonstrates AYP-101's significant potential in the localized fat reduction market". AMI Pharm is currently accelerating its Phase 3 study for AYP-101 with the goal of completion by the end of 2025. The company is also actively expanding international collaborations to further develop next-generation injectable drugs for localized fat reduction. This latest publication follows the positive results from AYP-101's Phase 1 study in 2024, continuing its international recognition.

SOURCE AMI Pharm