AMI Pharm’s novel injectable, AYP-101, has delivered promising Phase 2 results in treating submental fat (SMF)—commonly called a double chin.
The data, published in Clinical Therapeutics, underscores AYP-101’s potential as a safe, effective, nonsurgical alternative for localized fat reduction.
Phase 2 Trial Highlights
The study tested AYP-101 at two concentrations and revealed impressive results for the 25 mg/mL dose administered every two weeks across six sessions.
Key outcomes:
- 96 participants enrolled.
- At 4 weeks post-treatment:
- 69.70% of patients in the 25 mg/mL group achieved ≥1-grade improvement on both ER-SMFRS and SR-SMFRS scales.
- This compares to 22.58% in placebo, a clear and statistically significant difference. - Safety & tolerability:
- AYP-101 is engineered to destroy fat via apoptosis, sparing surrounding tissue.
- Required fewer injection points than existing options.
- Reported lower swelling and paresthesia compared to Deoxycholic Acid (DCA).
Why It Matters for Aesthetics
The demand for nonsurgical fat reduction is surging worldwide. Unlike traditional treatments, AYP-101 offers:
- Greater efficacy in moderate to severe SMF.
- A better patient experience with fewer side effects.
- A potential advancement over DCA-based injectables.
Company Outlook
Ki-Taek Lee, CEO of AMI Pharm:
“The Phase 2 data reaffirms our research capabilities and demonstrates AYP-101’s significant potential in the localized fat reduction market.”
Next steps:
- Phase 3 trial underway, aiming for completion by end of 2025.
- Expansion of global collaborations to develop next-gen injectables for targeted fat reduction.
- Builds on momentum from successful Phase 1 results (2024), furthering international recognition.
