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).
Go deeper with GlobalData
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.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataNeuroBo 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.
