{"id":29880,"date":"2025-08-11T19:58:51","date_gmt":"2025-08-11T19:58:51","guid":{"rendered":"https:\/\/www.hotelsalepage.com\/feed\/cision-pr-newswire\/ami-pharm-advances-ayp-101-to-phase-3-paving-the-way-for-a-new-era-in-fat-reduction-injectable-drugs\/"},"modified":"2025-08-11T19:58:51","modified_gmt":"2025-08-11T19:58:51","slug":"ami-pharm-advances-ayp-101-to-phase-3-paving-the-way-for-a-new-era-in-fat-reduction-injectable-drugs","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=29880","title":{"rendered":"AMI Pharm Advances AYP-101 to Phase 3, Paving the Way for a New Era in Fat-Reduction Injectable drugs"},"content":{"rendered":"\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u2014 Novel non-cytolytic injectable drug targets submental fat with significantly reduced pain and swelling
\u2014 Phase 3 clinical trial underway in South Korea<\/span>, following strong safety and efficacy results in earlier studies
\u2014 AMI Pharm positions itself for global expansion in the multi-billion-dollar non-surgical aesthetics market<\/b><\/p>\n

SEOUL, South Korea<\/span><\/span>, Aug. 11, 2025<\/span><\/span> \/PRNewswire\/ —\u00a0AMI Pharm<\/a><\/b>, a biotechnology company specializing in next-generation aesthetic solutions, today announced that its lead drug candidate, AYP-101<\/b>, has entered a pivotal Phase 3 clinical trial<\/b> for the treatment of submental fat<\/b> (commonly known as a “double chin”). This innovative injectable drug is designed to dramatically improve patient comfort by utilizing a novel biological mechanism that minimizes the pain and swelling commonly associated with existing treatments.<\/p>\n

\n<\/div>\n

A Paradigm Shift in Fat Reduction Therapy<\/b><\/p>\n

Currently, the only FDA-approved drug for localized fat reduction is based on deoxycholic acid<\/b>, which destroys fat cells through necrosis<\/b>\u2014a process that induces inflammation and leads to significant side effects such as pain, bruising, and prolonged swelling. In contrast, AYP-101<\/b> is uniquely engineered to eliminate fat through apoptosis<\/b>, a natural and controlled form of programmed cell death that does not trigger inflammation.<\/p>\n

This non-cytolytic mechanism offers a gentler, more tolerable<\/b> alternative, potentially eliminating the need for social downtime and offering a safer, more comfortable experience for patients seeking non-surgical fat reduction.<\/p>\n

Phase 3 Trial Underway Following Strong Early Results<\/b><\/p>\n

The ongoing Phase 3 clinical trial<\/b> involves 252 participants<\/b> across multiple sites in South Korea<\/span> and is expected to be completed by the end of 2025<\/b>. The study builds on successful Phase 1 and 2 trials<\/b>, which met all primary safety and efficacy endpoints.<\/p>\n

In the Phase 2 trial, over 70%<\/b> of patients in the AYP-101 group achieved at least a 1-grade improvement<\/b> on the Evaluator-Reported Submental Fat Rating Scale (ER-SMFRS)<\/b> in the per-protocol (PP) population. The treatment also showed excellent tolerability and safety<\/b>, with minimal adverse events reported.<\/p>\n

“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<\/span>, CEO of AMI Pharm<\/b>. “By leveraging a novel mechanism of action, we are pioneering the next generation of injectable drugs in aesthetic medicine.”<\/p>\n

Targeting Global Expansion and Broader Indications<\/b><\/p>\n

AMI Pharm is actively preparing for global commercialization. The company is engaging international partners and showcasing its clinical data at world-renowned conferences, including the BIO International Convention<\/b> and the IMCAS World Congress<\/b>.<\/p>\n

While the current clinical focus is on submental fat, AMI Pharm is laying the groundwork to expand AYP-101’s indications<\/b> to address other high-demand aesthetic areas, including cellulite<\/b>, deep buccal (cheek) fat<\/b>, and upper arm fat<\/b>. This broader R&D strategy highlights the company’s commitment to addressing a wide spectrum of unmet needs<\/b> in the aesthetic space and reinforces its ambition to become a global leader in non-surgical body contouring<\/b>.<\/p>","protected":false},"excerpt":{"rendered":"

<\/p>\n\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u2014 Novel non-cytolytic injectable drug targets submental fat with significantly reduced pain and swelling
\u2014 Phase 3 clinical trial underway in South Korea<\/span>, following strong safety and efficacy results in earlier studies
\u2014 AMI Pharm positions itself for global expansion in the multi-billion-dollar non-surgical aesthetics market<\/b><\/p>\n

SEOUL, South Korea<\/span><\/span>, Aug. 11, 2025<\/span><\/span> \/PRNewswire\/ —\u00a0AMI Pharm<\/a><\/b>, a biotechnology company specializing in next-generation aesthetic solutions, today announced that its lead drug candidate, AYP-101<\/b>, has entered a pivotal Phase 3 clinical trial<\/b> for the treatment of submental fat<\/b> (commonly known as a “double chin”). This innovative injectable drug is designed to dramatically improve patient comfort by utilizing a novel biological mechanism that minimizes the pain and swelling commonly associated with existing treatments.<\/p>\n

\n<\/div>\n

A Paradigm Shift in Fat Reduction Therapy<\/b><\/p>\n

Currently, the only FDA-approved drug for localized fat reduction is based on deoxycholic acid<\/b>, which destroys fat cells through necrosis<\/b>\u2014a process that induces inflammation and leads to significant side effects such as pain, bruising, and prolonged swelling. In contrast, AYP-101<\/b> is uniquely engineered to eliminate fat through apoptosis<\/b>, a natural and controlled form of programmed cell death that does not trigger inflammation.<\/p>\n

This non-cytolytic mechanism offers a gentler, more tolerable<\/b> alternative, potentially eliminating the need for social downtime and offering a safer, more comfortable experience for patients seeking non-surgical fat reduction.<\/p>\n

Phase 3 Trial Underway Following Strong Early Results<\/b><\/p>\n

The ongoing Phase 3 clinical trial<\/b> involves 252 participants<\/b> across multiple sites in South Korea<\/span> and is expected to be completed by the end of 2025<\/b>. The study builds on successful Phase 1 and 2 trials<\/b>, which met all primary safety and efficacy endpoints.<\/p>\n

In the Phase 2 trial, over 70%<\/b> of patients in the AYP-101 group achieved at least a 1-grade improvement<\/b> on the Evaluator-Reported Submental Fat Rating Scale (ER-SMFRS)<\/b> in the per-protocol (PP) population. The treatment also showed excellent tolerability and safety<\/b>, with minimal adverse events reported.<\/p>\n

“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<\/span>, CEO of AMI Pharm<\/b>. “By leveraging a novel mechanism of action, we are pioneering the next generation of injectable drugs in aesthetic medicine.”<\/p>\n

Targeting Global Expansion and Broader Indications<\/b><\/p>\n

AMI Pharm is actively preparing for global commercialization. The company is engaging international partners and showcasing its clinical data at world-renowned conferences, including the BIO International Convention<\/b> and the IMCAS World Congress<\/b>.<\/p>\n

While the current clinical focus is on submental fat, AMI Pharm is laying the groundwork to expand AYP-101’s indications<\/b> to address other high-demand aesthetic areas, including cellulite<\/b>, deep buccal (cheek) fat<\/b>, and upper arm fat<\/b>. This broader R&D strategy highlights the company’s commitment to addressing a wide spectrum of unmet needs<\/b> in the aesthetic space and reinforces its ambition to become a global leader in non-surgical body contouring<\/b>.<\/p>\n

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