NeuroBo Pharmaceuticals has filed an investigational new drug (IND) application with the US Food and Drug Administration (FDA) to commence a Phase I clinical trial of new treatment candidate, DA-1726, for obesity.
A dual oxyntomodulin (OXM) analog agonist, DA-1726 works as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR).
The sequential parallel group, double-blind, randomised, placebo-controlled trial will assess the tolerability, safety, pharmacodynamics and pharmacokinetics of the new product in obese participants who are otherwise healthy.
The Part 1 single ascending dose (SAD) portion of the trial plans to enrol about 45 subjects across five cohorts.
Subsequently, the Part 2 multiple ascending dose (MAD) portion will enrol nearly 36 subjects, randomised into four planned cohorts.
Evaluating the tolerability and safety of DA-1726 will be the primary endpoint of the trial.
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For this, the trial will observe adverse events (AEs), serious AEs, treatment emergent AEs and AEs that lead to discontinuation of the treatment in subjects.
The pharmacokinetics of DA-1726 will be included as the secondary endpoints of the trial.
DA-1726’s impact on metabolic and cardiac parameters, as well as on body weight, waist circumference, and body mass index (BMI) will be evaluated as exploratory endpoints.
In preclinical mice models, the treatment was shown to offer enhanced weight loss compared to other treatments, semaglutide and cotadutide.
It is designed to be used once a week subcutaneously.
NeuroBo Pharmaceuticals president and CEO Hyung Heon Kim said: “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.
“Additionally, the administration of DA-1726 resulted in similar weight reduction while consuming more food compared to tirzepatide (Mounjaro).
“We look forward to initiating the clinical development for DA-1726, with the first dose expected to be administered in the first half of 2024 and an expected data readout in the first half of 2025.”