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NeuroBo Pharmaceuticals Doses First Patient in Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity
Phase 1 Clinical Trial Timelines Significantly Accelerated Top-Line Data Readout from Single Ascending Dose Part 1 Now Expected in the Third Quarter of 2024
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[{"type":"text","content":"Phase 1 Clinical Trial Timelines Significantly Accelerated\nTop-Line Data Readout from Single Ascending Dose Part 1 Now Expected in the Third Quarter of 2024\nFirst Patient Dosed in the Multiple Ascending Dose Part 2 Expected in the Third Quarter of 2024\nCAMBRIDGE, Mass., April 17, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced dosing of the first patient in the single ascending dose (SAD) Part 1 of its two-part Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity.\n\n\"Dosing of the first patient in this trial is a groundbreaking achievement in the development of DA-1726, marking the first time this cardiometabolic asset will be tested in humans, bringing it one step closer to treating obesity, utilizing a novel mechanism as compared to other currently available treatments,\" stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. \"Although the main goal of the SAD part of this study is to assess the safety and tolerability of DA-1726, based on pre-clinical evidence, we believe that it may have a better tolerability profile than currently available GLP-1 agonists due to its balanced activation of GLP1R and glucagon receptors, reducing food intake while also increasing energy expenditure. Specifically, in pre-clinical mouse models, DA-1726 showed superior weight loss compared to semaglutide (Wegovy®) and resulted in similar weight reduction while consuming more food compared to tirzepatide (Zepbound™). Notably, we have significantly accelerated the timelines for the Phase 1 trial, and look forward to dosing the first patient in the multiple ascending dose (MAD) Part 2 in the third quarter of this year. Additionally, we now expect to report top-line data from the SAD Part 1 in the third quarter of 2024, and the MAD Part 2 in the first quarter of 2025.\"\nThe Phase 1 trial is designed to be a randomized, placebo-controlled, double-blind, two-part 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. The Part 1 SAD...