NeuroBo Pharma Seeks FDA Approval for Obesity Treatment Trial

02 January 2024 | Tuesday | News

NeuroBo Pharmaceuticals Submits IND Application to the FDA for a Phase 1 Clinical Trial of DA-1726 for the Treatment of Obesity
Image Source : Public Domain

Image Source : Public Domain

NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases,  announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). The IND application supports a 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.

"Filing of the IND for DA-1726 is as a seminal event in the development of this GLP-1 and glucagon dual receptor, bringing it one step closer to the clinic as a potential new treatment to address the significant obesity market," stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. "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™). 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 glycemic control and may have a better tolerability profile than current GLP-1 agonists. 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."

The Phase 1 trial is designed to be a randomized, 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 obese, otherwise healthy subjects. Part 1 will be a single ascending dose (SAD) study, expected to enroll approximately 45 participants, randomized into one of 5 planned cohorts. Each cohort will be randomized in a 6:3 ratio of DA-1726 or placebo. Part 2 will be a multiple ascending dose (MAD) study, expected to enroll approximately 36 participants, who will be randomized into 4 planned cohorts, each to receive 4 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.

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