NeuroBo Pharmaceuticals has dosed the first patient in the multiple ascending dose (MAD) Part 2 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.
The Phase 1 trial is currently designed to be a randomised, placebo-controlled, double-blind, two-part study to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of DA-1726 in patients with obesity and otherwise healthy subjects. The Part 1 SAD study is expected to enrol approximately 45 participants, randomised into one of 5 planned cohorts. Each cohort will be randomized in a 6:3 ratio of DA-1726 or placebo.
Part 2 is designed as a MAD study, expected to enrol approximately 36 participants, who will be randomised at the same 6:3 ratio 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.
"As we have noted previously, in pre-clinical mouse models, DA-1726 showed superior weight loss versus semaglutide (Wegovy) and resulted in similar weight reduction while consuming more food compared to tirzepatide (Zepbound). Additionally, as we presented at the American Diabetes Association 84th Scientific Sessions, DA-1726 also demonstrated superior weight loss, compared to survodutide, a drug with the same mechanism of action, while also demonstrating retention of relative lean body mass preservation compared to survodutide and exhibiting superior glucose lowering,” explained Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. “Based on this evidence, we believe that DA-1726 may potentially distinguish itself as a best-in-class obesity drug with a better tolerability profile than currently marketed GLP-1 agonists, as well as those in late-stage clinical trials, given its balanced activation of GLP1R and glucagon receptors, while increasing energy expenditure. Both Part 1 and Part 2 of the Phase 1 trial are proceeding well, and we anticipate reporting top-line data from the SAD Part 1 during the third quarter of this year, and from the MAD Part 2 in the first quarter of 2025.”