NeuroBo Pharmaceuticals Advances DA-1726, An Obesity Treatment
NeuroBo Pharmaceuticals Advances DA-1726 for Obesity Treatment
NeuroBo Pharmaceuticals, Inc. (NASDAQ: NRBO), a cutting-edge clinical-stage biotechnology firm, has achieved a remarkable milestone by announcing positive top-line data from the single ascending dose (SAD) Part 1 of its Phase 1 clinical trial for DA-1726. This innovative treatment aims to combat obesity, a condition affecting millions globally, by targeting metabolic pathways with its unique mechanism of action.
Promising Phase 1 Clinical Trial Results
In the SAD Part 1 of the Phase 1 clinical trial, 45 otherwise healthy participants who were obese were enrolled in a rigorous, double-blind study. These individuals were randomly assigned in a 6:3 ratio to receive either the investigational drug DA-1726 or a placebo. The preliminary results revealed an encouraging safety profile, with no major adverse events reported among participants. Notably, only five individuals in the DA-1726 group experienced adverse events compared to three in the placebo group. These findings suggest that DA-1726 is well-tolerated, paving the way for further studies.
Strength of the Data Collected
The data collected not only highlight the safety and tolerability of the drug but also indicated a dose-linear pharmacokinetic (PK) profile. The clinical team is actively incorporating additional cohorts into the SAD Part 1 trial to further determine the maximum tolerated dose of DA-1726, providing researchers deeper insights into the drug's efficacy and safety.
Anticipated Next Steps for DA-1726
Hyung Heon Kim, President and CEO of NeuroBo Pharmaceuticals, shared his enthusiasm regarding the results: "The safety, tolerability, and dose-linear PK data generated from the Part 1 SAD trial are highly encouraging. We are rapidly advancing into our multiple ascending dose (MAD) study, and we are optimistic about what the future holds for DA-1726 in addressing obesity." The MAD Phase 1 trial is designed as a placebo-controlled, randomized study that aims to explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of DA-1726 through multiple ascending doses.
Details of the MAD Trial
This next phase will involve approximately 36 participants, similarly randomized to either receive DA-1726 or a placebo across four cohorts. Each participant in the MAD trial will receive treatment once a week for four consecutive weeks, allowing the research team to closely monitor outcomes and refine the data about the drug's effectiveness.
Understanding DA-1726 and Its Mechanism
DA-1726 exemplifies the next generation of obesity treatments, functioning as a dual agonist for glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR). This mechanism promotes weight loss by suppressing appetite and enhancing energy expenditure. Pre-clinical studies have shown that DA-1726 offers improved weight loss outcomes compared to existing therapies like semaglutide (Wegovy). With the rising prevalence of obesity and its associated metabolic conditions, the development of DA-1726 could represent a paradigm shift in obesity treatment strategies.
About NeuroBo Pharmaceuticals
NeuroBo Pharmaceuticals, Inc. is on a mission to transform the treatment landscape for cardiometabolic diseases. Alongside DA-1726, they are also advancing DA-1241, a potent GPR119 agonist, which has shown promise in managing metabolic dysfunction-associated steatohepatitis (MASH). The company focuses on leveraging innovative biopharmaceutical approaches to address critical health challenges.
Frequently Asked Questions
What is DA-1726?
DA-1726 is a novel oxyntomodulin analog developed as a dual agonist for GLP1R and GCGR, aiming to effectively treat obesity.
When will the next results from the clinical trial be available?
The next readout of results is expected in the first quarter of 2025 from the MAD Part 2 trial, which will provide insights into clinical efficacy.
How safe is DA-1726 based on current data?
Current data from the SAD Part 1 trial indicate a favorable safety and tolerability profile, with no serious adverse events reported.
What are the next steps for DA-1726?
Following positive results, NeuroBo is adding more cohorts to the SAD Part 1 trial and transitioning to the MAD trial phase.
What else is NeuroBo Pharmaceuticals developing?
In addition to DA-1726, NeuroBo Pharmaceuticals is also developing DA-1241, aimed at treating metabolic dysfunction-associated steatohepatitis.
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