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FDA Clears Investigational New Drug Application for Dual Oxyntomodulin Analog Agonist, DA-1726

Image Credit: © Aerial Mike – stock.adobe.com

NeuroBo Pharmaceuticals has announced that the FDA has cleared its Investigational New Drug (IND) application for DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist, according to a company press release.1

DA-1726, which showed persistent weight loss in preclinical studies, functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR). NeuroBo also announced that it will be testing the efficacy of DA-1726 with plans to initiate a Phase I clinical trial for the treatment of obesity in the first half of 2024.

“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 CEO of NeuroBo in the press release. “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…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 I trial will be a randomized, placebo-controlled, double-blind, sequential parallel group study testing the safety and tolerability of DA-1726 in single and multiple ascending doses. Part 1 of the study will test the single ascending dose with approximately 45 participants while part 2 will test the multiple ascending doses with an expected enrollment of 36.

The primary endpoint of the study will assess the safety and tolerability of DA-1726 by monitoring adverse events. The study will investigate pharmacokinetics and other exploratory endpoints such as metabolic parameters, cardiac parameters, fasting lipid levels, and body weight.

Reference

  1. NeuroBo Pharmaceuticals Announces FDA Clearance of IND for a Phase 1 Clinical Trial of DA-1726 for the Treatment of Obesity. News release. February 1, 2024. Accessed February 2, 2024. https://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-announces-fda-clearance-of-ind-for-a-phase-1-clinical-trial-of-da-1726-for-the-treatment-of-obesity-302050383.html