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NeuroBo Pharmaceuticals Announces Positive Top-Line Data From the SAD Part 1 of Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity
Data Revealed Favorable Safety, Tolerability and Dose-Linear Pharmacokinetics (PK) Top-Line Data Readout from the MAD Part 2 Expected in the First Quarter of
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[{"type":"text","content":"Data Revealed Favorable Safety, Tolerability and Dose-Linear Pharmacokinetics (PK)\nTop-Line Data Readout from the MAD Part 2 Expected in the First Quarter of 2025\nPlanned Phase 1 Part 3 Will Evaluate Early Proof of Concept\nCAMBRIDGE, Mass., Sept. 30, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced positive top-line safety, tolerability, and dose-linear pharmacokinetics (PK) data from the single ascending dose (SAD) Part 1 of its 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\nIn the SAD Part 1 of the Phase 1 clinical trial, a total of 45 obese, otherwise healthy participants were randomized in a double-blind, 6:3 ratio of DA-1726 or placebo. Single ascending doses were found to be safe and well tolerated, with no serious adverse events. Only 5 subjects in the DA-1726 treatment group reported adverse events (AEs) compared with 3 subjects in the placebo group. A dose-linear PK profile was observed across the investigated dose range. Additional cohorts are being added to the SAD Part 1 to explore the maximum tolerated dose.\n\"The safety, tolerability and dose-linear PK data generated from the Part 1 SAD trial are highly encouraging and allowed for the accelerated initiation of our multiple ascending dose (MAD) study,\" stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. \"In light of the strong safety profile from the SAD Part 1 of the study, we are in the process of adding one or more cohorts to further explore the maximum tolerated dose, which will allow us to realize the full potential of DA-1726. Based on the preclinical data generated to date, as well as DA-1726's balanced activation of GLP1R and glucagon receptors, which increases energy expenditure, we continue to believe that DA-1726 may become a best-in-class obesity drug with a better tolerability profile than currently marketed GLP-1 agonists, and those now in late-stage clinical trials. We eagerly anticipate reporting top-line data from the MAD Part 2 in the first quarter of 2025, which will give us an early read on clinical efficacy. Additionally, we continue to pla...