Celltrion announced on the 4th that it presented the results of a joint study with Japan’s Skochia Pharma at “TIDES Europe,” held in Amsterdam, the Netherlands, from the 3rd to the 5th (local time). The study included receptor-specific cellular activity assessments and pharmacological evaluations of body weight, body composition, and insulin levels in an obese animal model (diet-induced obese rats).
CT-G32/SCO-940 is a next-generation quadruple agonist that simultaneously targets the GLP-1, GIP, glucagon, and amylin pathways. Based on the disclosed development status, Celltrion explained that CT-G32/SCO-940 is the first obesity treatment candidate to combine these four pathways.
In animal models of obesity, CT-G32/SCO-940 demonstrated greater weight loss when administered at the same dose as the representative triple agonist retatruotide. The proportion of lean body mass lost during weight loss was also relatively lower than that of the comparator drug.
The company also noted that the drug was observed to lower excessive blood insulin levels associated with obesity. It views these results as supporting the potential to develop CT-G32/SCO-940 as a treatment for metabolic disorders. Furthermore, it added that pharmacokinetic evaluations in non-human primates confirmed the drug maintains long-term exposure in the body, suggesting the potential to develop a once-weekly dosing regimen.
Celltrion plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) by February of next year. If the regulatory review proceeds smoothly, the company will initiate global clinical trials with the goal of administering the first dose to patients in the second quarter of the same year.
The company intends to develop CT-G32/SCO-940 as a first-in-class new drug designed to address unmet medical needs, such as individual variations in efficacy among existing GLP-1-based therapies and muscle loss during weight loss. The company plans to develop it as part of its obesity and metabolic disease pipeline, targeting weight loss, body composition improvement, and energy metabolism regulation simultaneously.
A Celltrion spokesperson stated, “CT-G32/SCO-940 is a core pipeline that has demonstrated in preclinical studies the potential to differentiate itself from existing dual- and triple-action agents through the world’s first quadruple-action combination simultaneously targeting GLP-1, GIP, glucagon, and amylin simultaneously—the world’s first quadruple-action combination—and is a core pipeline whose potential for differentiation beyond existing dual- and triple-action agents has been confirmed in preclinical studies,” the spokesperson said. “We will proceed smoothly with the clinical trial process to develop it into a next-generation therapy that encompasses not only weight loss but also improvements in body composition and metabolism.”