HM17321 demonstrates remarkable improvement in weight loss quality as monotherapy and in combination with incretins
[by Ji, Yong Jun] Hanmi Pharmaceutical announced on November 6 that it received approval from the U.S. Food and Drug Administration (FDA) on November 4 (local time) for its Investigational New Drug (IND) application to initiate Phase 1 clinical trials of its novel 바카라사이트 유니벳 treatment candidate (LA-UCN2, development code: HM17321).
The 바카라사이트 유니벳 clinical trial will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM17321 in both healthy adult participants and obese patients.
HM17321 is a Urocortin-2 (UCN2) analog that selectively targets the corticotropin-releasing factor 2 (CRF2) receptor. It is being developed as a first-in-class, innovative 바카라사이트 유니벳 treatment designed to simultaneously promote muscle mass increase while selectively reducing fat mass.
The CRF family of signaling molecules plays a key role in the body’s stress response and recovery mechanisms. According to Hanmi Pharmaceutical, selective activation of the CRF2 receptor within this family can directly promote fat reduction, enhance muscle growth, and improve overall muscle function.
HM17321 not only presents a new therapeutic paradigm in the treatment of 바카라사이트 유니벳 as a monotherapy but also demonstrates superior weight loss efficacy, both quantitatively and qualitatively, when used in combination with existing incretin-based 바카라사이트 유니벳 treatments, broadening the potential for innovative expansion.
Most antibody-based therapies aimed at preserving muscle mass require intravenous (IV) administration, making them less convenient for obese patients. Moreover, when used in combination with existing subcutaneous (SC) 바카라사이트 유니벳 treatment, the difference in administration methods poses additional challenges. These drugs also present limitations such as notable side effects, insufficient muscle mass preservation, and minimal improvement in muscle function.
In contrast, HM17321 is designed as a ‘peptide-based substance,’ providing greater convenience of administration and cost-effectiveness. Notably, if developed as a combination therapy, it could substantially improve patient convenience by enabling simultaneous administration with existing incretin-based drugs of the same peptide class.
Hanmi Pharmaceutical's obesity drug initiative, known as the ‘H.O.P (Hanmi Obesity Pipeline),’ consists of six pipelines that are being developed through a systematic, multi-layered mechanism of action and a differentiated strategic approach. Recently, the company announced interim top-line results from the Phase 3 clinical trial for ‘Efpeglenatide," the first H.O.P product slated for launch, marking a major milestone forward establishing it as a ‘national obesity drug’ distinguished by its excellent efficacy and proven safety profile.
The second pipeline of the H.O.P. program, a next-generation triple agent (LA-GLP/GIP/GCG, development code HM15275) for obesity treatment, received approval for its IND application in July for Phase 2 clinical trials. Hanmi Pharmaceutical has officially commenced the development of this candidate as a ‘best-in-class’ novel drug for obesity treatment, aiming for commercialization by 2030.
HM17321, the third pipeline in the H.O.P program, has demonstrated a high probability of clinical success based on preclinical and mechanistic studies conducted in overweight and obese primate models. Building on these promising results, 바카라사이트 유니벳 Pharmaceutical intends to accelerate the clinical development of HM17321 by mobilizing company-wide resources, with the objective of achieving commercialization by 2031.
"HM17321 is fundamentally differentiated from existing obesity treatments in that it is not merely a weight-loss agent but rather aims to simultaneously deliver the integrated therapeutic benefits of fat reduction, muscle gain, and enhanced exercise and metabolic function," said Choi In-young, Executive Director and Head of Hanmi's R&D Center.
"Hanmi Pharmaceutical does not regard obesity merely as a number on the scale but as the underlying cause of metabolic diseases. We aim to pioneer a new paradigm in obesity treatment by delivering 'patient-centered and personalized therapeutic solutions,'" Choi further added.