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NeuroBo Pharmaceuticals Announces FDA Clearance of IND for a Phase 1 Clinical Trial of DA-1726 for the Treatment of Obesity

Preclinical Studies Show DA-1726 Elicits Superior Weight Loss Compared to Semaglutide (Wegovy™) and Similar Weight Loss Compared to Tirzepatide (Mounjaro™), While Consuming More Food

Initiation of Phase 1 Clinical Trial Expected to Occur in the First Half of 2024

Excerpt from the Press Release:

CAMBRIDGE, Mass., Feb. 1, 2024 /PRNewswire/ — NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR). The company plans to initiate a Phase 1 clinical trial, for the treatment of obesity, in the first half of this year.

“Clearance of the IND for DA-1726 allows us to proceed with the Phase 1 program for this novel GLP-1 and glucagon dual receptor, a potential new treatment to address the significant obesity market,” stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. “As previously reported, preclinical evidence has shown that DA-1726 results in persistent weight loss in diet-induced obese mice and rats by reducing food intake while increasing energy expenditure. Additionally, in mouse models, DA-1726 showed superior weight loss compared to semaglutide (Wegovy™), and its administration resulted in similar weight reduction while consuming more food compared to tirzepatide (Mounjaro™). Based on these results, it is our belief that DA-1726 may have a better tolerability profile than currently available GLP-1 agonists due to its balanced activation of GLP1R and glucagon receptors. We look forward to dosing the first patient with DA-1726 during the first half of this year with an expected data readout in the first half of 2025.”

The Phase 1 trial is designed to be a randomized, placebo-controlled, double-blind, sequential parallel group study to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of DA-1726 in obese, otherwise healthy subjects.

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