NeuroBo Pharmaceuticals and FDA

NeuroBo Pharmaceuticals Rockets on FDA Approval for Obesity Trials

In a significant stride towards combating obesity, NeuroBo Pharmaceuticals has garnered the much-coveted green light from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for DA-1726, a groundbreaking treatment prospect for obesity. This milestone has not only spurred investor confidence but has also sent shockwaves through the stock market, with NeuroBo Pharmaceuticals witnessing a remarkable surge. As the market opened on Thursday, the company’s shares skyrocketed to $3.96, a notable jump from the previous day’s closing figure of $3.27.

At the time of this publication, NeuroBo Pharmaceuticals Inc stock (NRBO) has witnessed a surge.
NeuroBo Pharmaceuticals Inc
Current Price: $5.19
Change : +1.92
Change (%): (58.56%)
Volume: 53.6M
Source: Tomorrow Events Market Data

DA-1726, a dual oxyntomodulin (OXM) analog agonist, is set to revolutionize obesity treatment by targeting both the glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR). Preclinical studies indicate that this dual-action mechanism could potentially induce weight loss by curbing food intake and boosting energy expenditure. Impressively, DA-1726 has demonstrated superior weight loss outcomes in animal models compared to semaglutide (Wegovy™) and comparable results to tirzepatide (Mounjaro™), even with higher food consumption.

With plans to initiate a Phase 1 clinical trial in the first half of the year, NeuroBo Pharmaceuticals is entering a critical phase in the development of DA-1726. This randomized, placebo-controlled, double-blind study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug in obese yet otherwise healthy subjects. The trial will consist of a single ascending dose (SAD) study with approximately 45 participants and a multiple ascending dose (MAD) study involving around 36 participants.

The primary focus of the trial will be on assessing the safety and tolerability of DA-1726, closely monitoring adverse events, serious adverse events, and any incidents leading to treatment discontinuation. Secondary endpoints will delve into the pharmacokinetics of the drug, while exploratory endpoints will explore its impact on metabolic and cardiac parameters, fasting lipid levels, body weight, waist circumference, and body mass index (BMI).

Hyung Heon Kim, President and CEO of NeuroBo, expressed unwavering optimism about the potential of DA-1726 in the obesity market. Kim emphasized the drug’s balanced activation of GLP1R and glucagon receptors, pointing towards a promising future for NeuroBo in the realm of obesity treatment. The company aims to dose the first patient in the first half of this year, with anticipated data readout in the first half of 2025.

NeuroBo Pharmaceuticals, with a dedicated focus on developing treatments for cardiometabolic diseases, boasts a robust pipeline that includes DA-1241 for Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Type 2 Diabetes Mellitus (T2DM), alongside the promising DA-1726 for obesity. As the pharmaceutical landscape braces for potential breakthroughs, NeuroBo remains at the forefront of innovative solutions in the fight against cardiometabolic diseases. Investors and stakeholders alike are keeping a close eye on the unfolding narrative of NeuroBo’s ambitious journey in reshaping the landscape of obesity treatment.

As NeuroBo Pharmaceuticals charts an ambitious course in the pursuit of innovative treatments, the recent FDA approval for DA-1726 positions the company at the forefront of groundbreaking advancements in the realm of obesity, underscoring its commitment to pushing the boundaries of medical possibilities.

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