NeuroBo Pharmaceuticals has announced the dosing of the first subject in the multiple ascending dose (MAD) Part 2 of its Phase I clinical trial of DA-1726 to treat obesity.
DA-1726 is a dual oxyntomodulin (OXM) analogue agonist targeting glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR).
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The two-part, randomised, double-blind, placebo-controlled study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of varying doses of DA-1726 in obese but otherwise healthy participants.
The single ascending dose (SAD) Part 1 is anticipated to include about 45 participants across five cohorts, with a 6:3 randomisation ratio for DA-1726 or placebo.
The subsequent MAD Part 2 aims to enrol roughly 36 participants, who will be similarly randomised into four cohorts. Each cohort will receive four weekly doses of either DA-1726 or a placebo.
Evaluating the safety and tolerability of the asset by tracking adverse events (AEs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and AEs leading to discontinuation of treatment is the trial’s primary endpoint.
NeuroBo president and CEO Hyung Heon Kim said: “Dosing of the first patient in Part 2 of this trial, late in the second quarter, ahead of schedule, is a further reflection of our strong commitment to swiftly advancing the clinical development of DA-1726, which holds promise as a highly differentiated therapy for the treatment of obesity.”
“We are now well capitalised to execute on our upcoming DA-1726 milestones following our recent, successful financing of up to $70m in aggregate gross proceeds, with $20m upfront and $50m of clinical milestone-based warrants, which we expect will enable us to fully fund a planned multicentre, randomised, double-blind, placebo-controlled Part 3 of this Phase I trial, which would begin upon completion of Part 2.”
The company will dose the first patient in the Part 3 portion of the trial in the third quarter of next year following clearance from the US for an updated investigational new drug application.
