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NeuroBo Pharmaceuticals Announces FDA Clearance of IND for a Phase 2a Clinical Trial of DA-1241 for the Treatment of NASH
Initiation of Phase 2a Clinical Trial Expected to Occur in Q3 2023 BOSTON, May 2, 2023 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a
About this update from Metavia Inc.
[{"type":"text","content":"Initiation of Phase 2a Clinical Trial Expected to Occur in Q3 2023\nBOSTON, May 2, 2023 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company on a quest to transform cardiometabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist. The company plans to initiate a two-part, Phase 2a clinical trial of DA-1241, for the treatment of nonalcoholic steatohepatitis (NASH), in the third quarter of 2023.\n\"Clearance of the IND for DA-1241 brings us one step closer to our goal of bringing this very promising cardiometabolic asset into clinical trials in patients with NASH, for which there is currently no approved treatment,\" stated Joe Hooker, Interim President and Chief Executive Officer of NeuroBo. \"In Phase 1a/1b clinical studies, DA-1241 was well tolerated in both healthy volunteers and in patients with type 2 diabetes mellitus (T2DM). Importantly, preclinical studies demonstrated that DA-1241 attenuated NASH progression by reducing pro-inflammatory cytokines and chemokines, stellate cell activation, and collagen deposition in the liver, thereby improving inflammation, hepatic steatosis, and fibrosis. In those studies, DA-1241 also improved both lipid metabolism and glucose control. For these reasons, we believe that the mechanism of action of DA-1241 will translate into a safe and effective treatment for NASH. We are eager to initiate the two-part, Phase 2a clinical trial of DA-1241, which we expect will occur in the third quarter of this year. The two-part design provides optionality for an interim analysis in the first half of 2024 and we anticipate full data in the second half of 2024.\n\"Looking ahead, we expect additional, near-term value creating milestones, including advancement of DA-1726, our second asset, through the IND process, with the goal of initiating a Phase 1a safety study in the first half of 2024 and an expected data readout in the second half of 2024. DA-1726 is a novel oxyntomodulin (OXM) analogue that acts as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. The drug candidate is in development for the treatment of obesity and has demonstrated superior body weight loss in prec...