2024-04-19 05:59:39
Dong-A ST’s U.S. neurobo ‘DA-1726‘ phase 1 clinical trial part 1 begins in earnest
Clinical results released in the third quarter of this year
Phase 1 clinical trial completed in the first half of next year
Pre-clinical data shows weight loss ↑ compared to Wegobee and Zebbound
Dong-A ST announced on the 18th that its U.S. subsidiary NeuroBo Pharmaceuticals (NeuroBo) has begun administering the first patient in part 1 of the global phase 1 clinical trial of ‘DA-1726’, which is being developed as an obesity treatment.
Neurobo received approval for DA-1726 global phase 1 clinical study from the U.S. Food and Drug Administration (FDA) in January. The first patient administration was administered to local residents at a designated clinical trial facility in the United States on the 17th (local time).
This clinical trial was designed as a study to confirm safety, tolerability, pharmacokinetics, and pharmacodynamics. It is divided into two parts and is conducted through randomization, double blind, placebo control, and parallel comparison.
Part 1 involves administering a single dose of DA-1726 or placebo to 45 obese patients and healthy adults. Clinical results are scheduled to be released in the third quarter of this year.
Part 2 will be a 4-week repeated administration test of DA-1726 or placebo in 36 obese patients and healthy adults. The plan is to start in the third quarter of this year, when Part 1 clinical results are announced, and to reveal the clinical results in the first quarter of next year. The end point of the entire phase 1 clinical trial is set for the first half of 2025.
DA-1726 is a new drug candidate being developed as an oxyntomodulin analogue treatment for obesity. It acts simultaneously on the GLP-1 receptor and the glucagon receptor to suppress appetite, promote insulin secretion, and increase peripheral basal metabolic rate, ultimately leading to weight loss and blood sugar control. It is a GLP-1 (glucagon-like peptide-1) receptor type obesity treatment with a similar mechanism as Denmark’s Novo Nordisk’s blockbuster obesity drugs Saxenda (ingredient name: liraglutide) and Wigobi (semaglutide).
Preclinical study data showed that DA-1726 showed excellent weight loss effects in obese animal models even with food intake similar to the GLP-1 analog semaglutide (Weigov). In a comparative study with Zebbound (ingredient name terzepatide, product name Maunjaro in countries other than the United States), the latest obesity treatment drug launched by Eli Lilly of the United States, a similar weight loss effect was confirmed even though more food was consumed. Terzepatide is a dual agonist of GLP-1 and GIP (Glucose-dependent insulinotropic peptide, glucose-dependent insulinotropic polypeptide). GIP is one of the duodenal hormones involved in insulin secretion and plays a role in promoting insulin secretion and reducing appetite.
Looking at the preclinical study results alone, DA-1726 is more effective in treating obesity than Novo Nordisk WiGobee and Eli Lilly Zebbound.
Kim Hyeong-heon, CEO of Neurobo Pharmaceuticals, said, “DA-1726 suppressed appetite in preclinical studies and at the same time increased basal metabolic rate, resulting in more energy consumption.” He added, “Following Part 1 of the Phase 1 clinical trial, we quickly proceeded with administering Part 2 to patients, providing innovative solutions. “We will take one step closer to developing a treatment for obesity,” he said.
Neurobo Pharmaceuticals is a NASDAQ-listed company located in Boston, USA. It serves as a global research and development (R&D) base for Dong-A Socio Group, which is responsible for the global development and commercialization of DA-1726, a new obesity treatment candidate, and DA-1241, which is being developed as a treatment for non-alcoholic steatohepatitis (MASH). . DA-1241, a MASH treatment candidate, is currently undergoing global phase 2 clinical trials.
Kim Min-beom, Donga.com reporter [email protected]
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2024-04-19 05:59:39