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AYP-101 von AMI Pharm erweist sich in Phase-2-Studie als vielversprechend und signalisiert einen Durchbruch bei der nicht-chirurgischen Fettreduktion
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AMI Pharm

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AMI Pharm

Sep 01, 2025, 03:00 ET

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  • AYP-101 von AMI Pharm wird mit erfolgreicher Phase-2-Studie zum neuen Marktführer im Bereich der nicht-chirurgischen Fettreduktion
  • Klinische Ergebnisse zu AYP-101, einer vielversprechenden nicht-chirurgischen Lösung, werden in Clinical Therapeutics veröffentlicht
  • AYP-101 zeigt überragende Sicherheit und Wirksamkeit und ist im Begriff, das Paradigma der submentalen Fettreduktion zu verändern

SEOUL, Südkorea, 1. September 2025 /PRNewswire/ -- Das neuartige injizierbare Medikament AYP-101 von AMI Pharm zeigte vielversprechende Phase-2-Studienergebnisse zur Reduzierung von submentalem Fett (SMF), allgemein bekannt als Doppelkinn. Die Ergebnisse der Studie wurden kürzlich in Clinical Therapeutics veröffentlicht, einer führenden Fachzeitschrift für Arzneimittel- und Therapieentwicklung. Diese Veröffentlichung stellt einen wichtigen Meilenstein für AYP-101 dar und unterstreicht sein Potenzial als sichere und wirksame nicht-chirurgische Behandlungsoption. Die Studie untersuchte die Wirksamkeit und Sicherheit von AYP-101 in zwei verschiedenen Konzentrationen. Die Ergebnisse zeigten, dass die 25 mg/ml-Konzentration, die alle zwei Wochen über sechs Sitzungen verabreicht wurde, zu einer statistisch signifikanten und klinisch bedeutsamen Verringerung von mittelschwerem bis schwerem SMF führte.

Nachgewiesene Wirksamkeit und Sicherheit

Die Phase-2-Studie umfasste 96 Teilnehmer und zeigte überzeugende Ergebnisse. Vier Wochen nach der letzten Behandlung erreichten 69,70 % der Teilnehmer in der 25-mg/ml-Behandlungsgruppe eine Verbesserung um mindestens eine Stufe sowohl auf der vom Prüfer berichteten Submentalfett-Bewertungsskala (ER-SMFRS) als auch auf der vom Probanden berichteten Submentalfett-Bewertungsskala (SR-SMFRS). Dies war eine statistisch signifikante Verbesserung im Vergleich zu der 22,58%igen Ansprechrate in der Placebogruppe. Die Studiendaten unterstreichen auch das günstige Sicherheits- und Verträglichkeitsprofil von AYP-101. Das Medikament ist so konzipiert, dass es Fett durch einen Prozess namens Apoptose beseitigt und gleichzeitig das umliegende Gewebe möglichst wenig schädigt. Die Studie ergab, dass für AYP-101 weniger Injektionspunkte erforderlich waren und weniger Schwellungen und Parästhesien nach der Injektion auftraten, als dies bei Deoxycholsäure (DCA) der Fall ist.

Ein führendes Unternehmen auf dem wachsenden Markt für Ästhetik

Da die weltweite Nachfrage nach nicht-chirurgischer Fettreduktion steigt, treibt AMI Pharm die Entwicklung von AYP-101 voran. Laut Ki-Taek Lee, CEO von AMI Pharm, „bestätigt die Phase-2-Veröffentlichung unsere Stärke in Forschung und Entwicklung und zeigt das bedeutende Potenzial von AYP-101 auf dem Markt für lokalisierte Fettreduktion". Die Phase-3-Studie für AYP-101 wird beschleunigt und soll bis Ende 2025 abgeschlossen werden. AMI Pharm baut auch aktiv internationale Kooperationen aus, um injizierbare Medikamente der nächsten Generation für die lokale Fettreduktion zu entwickeln. Diese jüngste Veröffentlichung folgt auf die positiven Ergebnisse der Phase-1-Studie von AYP-101 im Jahr 2024 und setzt dessen internationale Anerkennung fort.

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