NeuroBo Pharmaceuticals has submitted an Investigational New Drug (IND) application to the FDA to support a Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analogue agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) for the treatment of obesity.
The Phase 1 trial is designed to be a randomised, placebo-controlled, double-blind, sequential parallel group study to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of DA-1726 in patients with obesity, but otherwise healthy subjects. Part 1 will be a single ascending dose (SAD) study, expected to enrol approximately 45 participants, randomised into one of five planned cohorts. Each cohort will be randomised in a 6:3 ratio of DA-1726 or placebo. Part 2 will be a multiple ascending dose (MAD) study, expected to enrol approximately 36 participants, who will be randomised into four planned cohorts, each to receive four weekly administrations of DA-1726 or placebo.
The primary endpoint will assess the safety and tolerability of DA-1726 by monitoring adverse events (AEs), serious adverse events (SAEs), treatment emergent adverse events (TEAEs) and AEs leading to treatment discontinuation. Secondary endpoints include the PK of DA-1726, assessed via serum concentrations over time and metabolite profiling at the highest doses of DA-1726. Exploratory endpoints will include the effect of DA-1726 on metabolic parameters, cardiac parameters, fasting lipid levels, body weight, waist circumference and body mass index (BMI), among others.
"Preclinical evidence shows that DA-1726 reduced food intake while also increasing energy expenditure, which resulted in persistent weight loss in diet-induced obese mice and rats. Importantly, in mouse models, DA-1726 showed superior weight loss compared to semaglutide (Wegovy),” said Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. “Additionally, the administration of DA-1726 resulted in similar weight reduction while consuming more food compared to tirzepatide (Mounjaro). It is our belief that DA-1726's balanced activation between GLP-1 and glucagon receptors, may lead to better glycaemic control and may have a better tolerability profile than current GLP-1 agonists.”