FDA clears NeuroBo's obesity drug for Phase 1 trials

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FDA clears NeuroBo's obesity drug for Phase 1 trials
Credit: © Reuters.

CAMBRIDGE, Mass. - NeuroBo Pharmaceuticals, Inc. (NASDAQ: NRBO ) has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for DA-1726, a novel treatment candidate for obesity. The company announced its plans to initiate a Phase 1 clinical trial within the first half of this year.

DA-1726 is a dual oxyntomodulin (OXM) analog agonist that targets both glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR). According to preclinical studies, this dual action mechanism may lead to weight loss by reducing food intake and increasing energy expenditure. The drug has shown promising results in animal models, demonstrating superior weight loss compared to semaglutide (Wegovy™) and comparable weight loss to tirzepatide (Mounjaro™), despite a higher food consumption.

The upcoming Phase 1 trial will be a randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of DA-1726 in obese but otherwise healthy subjects. The study will be divided into two parts: a single ascending dose (SAD) study with approximately 45 participants and a multiple ascending dose (MAD) study with around 36 participants.

Primary endpoints of the trial will focus on the safety and tolerability of DA-1726, monitoring adverse events, serious adverse events, and any events leading to treatment discontinuation. Secondary endpoints will include the pharmacokinetics of DA-1726, while exploratory endpoints will observe the drug's effect on metabolic and cardiac parameters, fasting lipid levels, body weight, waist circumference, and body mass index (BMI).

NeuroBo's President and CEO, Hyung Heon Kim, expressed optimism about DA-1726's potential in the obesity market, highlighting the drug's balanced activation of GLP1R and glucagon receptors. The company anticipates dosing the first patient in the first half of this year, with an expected data readout in the first half of 2025.

NeuroBo Pharmaceuticals is focused on developing treatments for cardiometabolic diseases, including DA-1241 for Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Type 2 Diabetes Mellitus (T2DM), in addition to DA-1726 for obesity.

This news is based on a press release statement from NeuroBo Pharmaceuticals.

InvestingPro Insights

As NeuroBo Pharmaceuticals, Inc. ( NASDAQ :NRBO) forges ahead with its Phase 1 clinical trial for obesity treatment candidate DA-1726, investors may find it useful to consider some financial metrics and strategic insights. The company's market capitalization stands at a modest $15.86 million, reflecting the size and speculative nature of its business in the biotechnology sector. Despite the challenges, NeuroBo holds more cash than debt on its balance sheet, which is a positive sign for its financial stability, especially as it embarks on costly clinical trials.

However, it's important to note that NeuroBo is not currently profitable, with an adjusted P/E ratio over the last twelve months as of Q3 2023 at -3.32, indicating that the company is in a pre-revenue stage typical for clinical-stage biotech firms. The company also quickly burns through cash and suffers from weak gross profit margins, which are critical considerations for potential investors looking at the long-term viability of NeuroBo.

InvestingPro Tips reveal that NeuroBo's stock price often moves in the opposite direction of the market, which could indicate a degree of non-correlation with broader market trends, possibly due to the company's specific industry dynamics. Additionally, the company's liquid assets exceed its short-term obligations, suggesting that it has a cushion to fund its operations in the near term. For those interested in deeper analysis, InvestingPro offers additional tips for NeuroBo, which can be accessed through a subscription that is currently on a special New Year sale with a discount of up to 50%. Use coupon code SFY24 to get an additional 10% off a 2-year InvestingPro+ subscription, or SFY241 to get an additional 10% off a 1-year InvestingPro+ subscription.

Given the early stage of NeuroBo's clinical development and the speculative nature of biotech investing, these insights and additional InvestingPro Tips could be a valuable resource for investors considering this stock.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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