NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO) has obtained its first site Institutional Review Board (IRB) approval from Dr. Alexander Prezioso, Investigator at Clinical Pharmacology of Miami in Hialeah, FL, to initiate the Phase 1 clinical trial of DA-1726. This novel compound, a dual oxyntomodulin (OXM) analog agonist targeting both the glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), aims to address obesity. The company expects to enroll the first patient in the second quarter of this year.

NeuroBo, commented, "With this initial site IRB approval, we have achieved another significant milestone in advancing DA-1726 towards clinical application." Kim highlighted the potential of DA-1726 to offer improved tolerability compared to existing GLP-1 agonists due to its balanced activation of GLP1R and glucagon receptors. Early studies in mouse models demonstrated superior weight loss efficacy compared to semaglutide (Wegovy®) and similar weight reduction to tirzepatide (Zepbound™) while consuming more food. The company is set to collaborate closely with its contract research organization (CRO) partner and investigators like Dr. Prezioso to initiate patient randomization in the second quarter of this year. Anticipated timelines include reporting top-line data from the single ascending dose (SAD) Part 1 in the first half of 2025 and the multiple ascending dose (MAD) Part 2 in the second half of 2025.

The Phase 1 trial is structured as a randomized, placebo-controlled, double-blind, two-part investigation focusing on safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of DA-1726 in obese, otherwise healthy subjects. Part 1 will involve a single ascending dose (SAD) study with approximately 45 participants, randomized into five planned cohorts. Part 2 will be a multiple ascending dose (MAD) study with approximately 36 participants, randomized into four planned cohorts, each receiving four weekly administrations of DA-1726 or placebo.

Primary endpoints include monitoring adverse events (AEs), serious adverse events (SAEs), treatment emergent adverse events (TEAEs), and AEs leading to treatment discontinuation to assess the safety and tolerability of DA-1726. Secondary endpoints involve evaluating the PK of DA-1726 and its effects on metabolic and cardiac parameters, fasting lipid levels, body weight, waist circumference, and body mass index (BMI), among others.

DA-1726 is an innovative oxyntomodulin (OXM) analogue functioning as a GLP1R/GCGR dual agonist designed for once-weekly subcutaneous administration. It targets both GLP-1 receptors (GLP1R) and glucagon receptors (GCGR), leading to weight loss by reducing appetite and increasing energy expenditure. In preclinical mouse models, DA-1726 has demonstrated superior weight loss efficacy compared to semaglutide and cotadutide, another OXM analogue.

 

Source: prnewswire.com

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