NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology company specializing in cardiometabolic diseases, has announced that the US Food and Drug Administration (FDA) has granted clearance for its Investigational New Drug (IND) application for DA-1726. 

This novel dual oxyntomodulin (OXM) analog agonist functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR). The company is set to commence a Phase 1 clinical trial for obesity treatment in the first half of this year.

Hyung Heon Kim, President and CEO of NeuroBo, expressed excitement about the FDA clearance, enabling the initiation of the Phase 1 program. "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," he said. 

The Phase 1 trial is designed as a randomized, placebo-controlled, double-blind study to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of DA-1726 in obese, otherwise healthy subjects. Part 1 involves a single ascending dose (SAD) study with approximately 45 participants, while Part 2 comprises a multiple ascending dose (MAD) study with around 36 participants. The primary endpoint is the safety and tolerability of DA-1726, with secondary endpoints focusing on pharmacokinetics, metabolic parameters, cardiac parameters, and more.

Kim anticipates dosing the first patient with DA-1726 in the first half of this year, with data readout expected in the first half of 2025. The company believes that DA-1726's balanced activation of GLP1R and glucagon receptors may result in a better tolerability profile compared to existing GLP-1 agonists. The Phase 1 trial marks a significant step in advancing this potential obesity treatment.