Celltrion announced on the 4th that it has disclosed nonclinical research results for 'CT-G32/SCO-940,' a new drug candidate for an obesity treatment that simultaneously targets four hormonal pathways, marking the world's first 'quadruple-action' agent.
The results were presented at 'TIDES Europe,' a global specialized academic conference held in Amsterdam, Netherlands, from the 3rd to the 5th (local time). The study, jointly presented by Celltrion and Japan's 'Scophia Pharma,' included assessments of cell activity per receptor for CT-G32/SCO-940, as well as pharmacological results regarding weight, body composition, and insulin levels observed in an obesity animal model (diet-induced obese rats).
Potential for Differentiation from Triple-Action Agents Confirmed
CT-G32/SCO-940 is a next-generation quadruple-action agent that simultaneously targets four hormonal pathways: △glucagon-like peptide-1 (GLP-1), △glucose-dependent insulinotropic polypeptide (GIP), △glucagon, and △amylin. Based on publicly available development status, CT-G32/SCO-940 is the first obesity treatment in the world to combine these four pathways into a single candidate molecule.
In animal model evaluations, CT-G32/SCO-940 demonstrated greater weight loss effects compared to the representative triple-action agent retatrutide when administered at the same dosage. During the weight loss process, the proportion of lean mass reduction, including muscle and skeletal tissue, was relatively smaller than that of the comparator drug, confirming the potential to improve the balance between weight loss and body composition management.
An effect in reducing excessive blood insulin levels associated with obesity was also observed. This is evaluated as nonclinical evidence showing the potential to expand CT-G32/SCO-940 beyond an obesity treatment into the field of metabolic disease therapeutics. In pharmacokinetic evaluations using primates, the drug's exposure within the body was maintained over a long period, further confirming the possibility of developing a once-weekly dosing formulation that could enhance patient convenience.
Celltrion plans to submit an Investigational New Drug (IND) application for CT-G32/SCO-940 to the U.S. Food and Drug Administration (FDA) by next February. Following this, if regulatory review proceeds smoothly, the company aims to initiate global clinical development with the goal of dosing the first patient in the second quarter of the same year.
Cultivating Next-Generation Pipeline for Obesity and Metabolic Diseases
Celltrion is committed to developing CT-G32/SCO-940 as a 'First-in-Class' new drug capable of addressing unmet needs, such as individual efficacy differences in existing GLP-1-based therapies and muscle loss during weight loss. Based on four complementary mechanisms, the company plans to cultivate it as a core next-generation pipeline in the obesity and metabolic disease sector by simultaneously targeting weight loss, body composition improvement, and energy metabolism regulation.
A Celltrion official stated, "CT-G32/SCO-940 is a core pipeline that has demonstrated differentiation potential in nonclinical studies as the world's first quadruple-action combination targeting GLP-1, GIP, glucagon, and amylin simultaneously, surpassing existing dual- and triple-action agents." The official added, "We will proceed with clinical entry without delay to develop it as a next-generation therapy that encompasses not only weight loss but also improvements in body composition and metabolism."
Alongside its obesity treatment, Celltrion is expanding its new drug portfolio with an antibody-drug conjugate (ADC) currently in Phase 1 clinical trials, a multi-antibody anticancer agent, and treatments for autoimmune diseases. The company's strategy is to diversify its medium- to long-term growth drivers by applying the global clinical, manufacturing, regulatory approval, and commercialization capabilities accumulated through its biosimilar (biologic copy drug) business to new drug development. All three ADC new drug candidates that have entered Phase 1 trials have been selected for the FDA's 'Fast Track' designation, which is expected to significantly accelerate their development speed.
Meanwhile, TIDES Europe is a global specialized academic conference that shares research and development achievements and industry trends in next-generation therapies, including peptides and oligonucleotides. This year's event features participation from over 100 companies and approximately 115 global experts as speakers.
in THEBIO
