NeuroBo Pharmaceuticals, Inc.
The company has submitted an IND application to the FDA for a Phase 1 trial of DA-1726 for treating obesity.
The DA-1726 is a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) for obesity.
Preclinical evidence shows that DA-1726 reduced food intake while increasing energy expenditure, resulting in persistent weight loss in diet-induced obese mice and rats.
"Importantly, in mouse models, DA-1726 showed superior weight loss compared to semaglutide (Wegovy™). Additionally, the administration of DA-1726 resulted in similar weight reduction while consuming more food compared to tirzepatide (Mounjaro™)," said Hyung Heon Kim, President and Chief Executive Officer of NeuroBo.
The Phase 1 trial is designed to be a randomized, placebo-controlled, double-blind and sequential parallel group study. Part 1 will be a single ascending dose (SAD) study, expected to enroll approximately 45 participants, randomized into one of 5 planned cohorts.
Part 2 will be a multiple ascending dose (MAD) study, expected to enroll approximately 36 participants, who will be randomized into 4 planned cohorts.
"Filing of the IND for DA-1726 is as a seminal event in the development of this GLP-1 and glucagon dual receptor, bringing it one step closer to the clinic as a potential new treatment to address the significant obesity market," added Hyung Heon Kim.
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