NeuroBo Pharmaceuticals Receives First Site IRB Approval for Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity

Rhea-AI Summary

NeuroBo Pharmaceuticals, Inc. (NRBO) receives IRB approval for Phase 1 trial of DA-1726, a novel cardiometabolic drug targeting obesity. First patient expected to be randomized in Q2 2024. Positive preclinical data suggests potential advantages over existing treatments. Top-line data expected in 2025.

Medical Research Analyst

The recent announcement from NeuroBo Pharmaceuticals regarding the IRB approval for Phase 1 clinical trials of DA-1726 is a pivotal step in the drug development process. This novel oxyntomodulin analog agonist, which targets both GLP1R and GCGR, is particularly noteworthy given the preliminary data suggesting a superior efficacy profile compared to existing treatments like semaglutide and tirzepatide in preclinical models. The dual mechanism of action has the potential to offer a differentiated therapeutic option in the obesity market, which is currently experiencing significant growth due to rising global obesity rates.

The design of the Phase 1 trial, with its focus on safety, tolerability, pharmacokinetics and pharmacodynamics, adheres to standard industry protocols for early-stage drug development. The primary and secondary endpoints are well-defined, which should provide clear data on the drug's safety profile and its metabolic effects. Given the obesity epidemic and the high demand for effective weight management solutions, the successful progression of DA-1726 could have substantial implications for NeuroBo's market valuation and future revenue streams.

Exploratory endpoints related to metabolic and cardiac parameters are particularly relevant, as they align with the broader cardiometabolic focus of NeuroBo. These could offer additional insights into the drug's impact on overall health beyond weight loss, which is a critical consideration for patients and healthcare providers. The timeline for data reporting is also significant, as investors will be closely monitoring the results of the SAD and MAD studies to gauge the drug's potential and inform their investment decisions.

Market Research Analyst

From a market perspective, the advancement of DA-1726 into Phase 1 trials signifies NeuroBo's entry into the competitive landscape of obesity treatments, a sector with a high unmet medical need and substantial commercial potential. The obesity treatment market is forecasted to grow, driven by lifestyle changes and a rising prevalence of obesity-related comorbidities. The mention of DA-1726's superior performance in preclinical models when compared to established drugs such as semaglutide and tirzepatide positions it as a potential market disruptor.

Investors will likely evaluate the implications of these clinical developments in the context of NeuroBo's overall pipeline and strategic positioning. The successful development of DA-1726 could enhance NeuroBo's portfolio and potentially lead to strategic partnerships or funding opportunities. However, it is crucial to consider the inherent risks of clinical trials, as many compounds fail to demonstrate safety and efficacy in human subjects despite promising preclinical results.

Furthermore, the obesity treatment market is not only large but also highly competitive, with several big pharma players and established drugs. NeuroBo will need to navigate market access challenges, including pricing, reimbursement and differentiation strategies, should DA-1726 reach the market. The long-term impact on the company's stock will depend on these factors, as well as the actual clinical trial outcomes and subsequent regulatory pathways.

Financial Analyst

The initiation of Phase 1 trials for DA-1726 is a critical event that could influence NeuroBo's financial trajectory. The capital requirements for conducting clinical trials are substantial and the announcement may lead to speculation on NeuroBo's need for additional funding, which could affect its stock performance. Investors will be assessing the burn rate and evaluating the possibility of dilutive financing rounds or the pursuit of non-dilutive funding such as grants or partnerships.

Given the early stage of the trial, the immediate financial impact is likely to be limited to research and development expenses. However, the potential future revenue from DA-1726, should it receive FDA approval, provides a speculative value to the company's stock. The projected timelines for the SAD and MAD studies and the subsequent top-line data release will be key dates for investors, as these will provide insights into the drug's viability and the company's ability to progress to later-stage trials.

It is also important to note that the biotech sector is highly volatile and stock prices can be significantly influenced by the outcomes of clinical trials. Positive results can lead to substantial stock appreciation, while negative results can have the opposite effect. Investors will be weighing these risks against the potential rewards of early investment in a company with a promising drug candidate for a lucrative market.

First Patient Expected to be Randomized in the Second Quarter of 2024

CAMBRIDGE, Mass., Feb. 29, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that it has received first site Institutional Review Board (IRB) approval for Alexander Prezioso, M.D., Investigator, Clinical Pharmacology of Miami, in Hialeah, FL, to proceed with the Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity. The company expects to randomize the first patient in the second quarter of this year.

"With this first site IRB approval, we have achieved another significant milestone in the development of DA-1726, bringing the program one step closer to the clinic," stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. "This promising cardiometabolic asset may have a better tolerability profile than currently available GLP-1 agonists due to its balanced activation of GLP1R and glucagon receptors. As previously reported, in mouse models, DA-1726 showed superior weight loss compared to semaglutide (Wegovy®), and its administration resulted in similar weight reduction while consuming more food compared to tirzepatide (Zepbound™). We look forward to working closely with our contract research organization (CRO) partner and our investigators, such as Dr. Prezioso, to start randomizing patients in the second quarter of this year. We expect to report top-line data from the single ascending dose (SAD) Part 1 in the first half of 2025 and the multiple ascending dose (MAD) Part 2 in the second half of 2025."

The Phase 1 trial is designed to be a randomized, placebo-controlled, double-blind, two-part study to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of DA-1726 in obese, otherwise healthy subjects. Part 1 will be a single ascending dose (SAD) study, expected to enroll approximately 45 participants, randomized into one of 5 planned cohorts. Each cohort will be randomized in a 6:3 ratio of DA-1726 or placebo. Part 2 will be a multiple ascending dose (MAD) study, expected to enroll approximately 36 participants, who will be randomized at the same 6:3 ratio into 4 planned cohorts, each to receive 4 weekly administrations of DA-1726 or placebo.

The primary endpoint will assess the safety and tolerability of DA-1726 by monitoring adverse events (AEs), serious adverse events (SAEs), treatment emergent adverse events (TEAEs) and AEs leading to treatment discontinuation. Secondary endpoints include the PK of DA-1726, assessed via serum concentrations over time and metabolite profiling at the highest doses of DA-1726. Exploratory endpoints will include the effect of DA-1726 on metabolic parameters, cardiac parameters, fasting lipid levels, body weight, waist circumference and body mass index (BMI), among others.

For more information on this clinical trial, please visit: www.clinicaltrials.gov NCT06252220.

About DA-1726

DA-1726 is a novel oxyntomodulin (OXM) analogue functioning as a GLP1R/GCGR dual agonist for the treatment of obesity and NASH that is to be administered once weekly subcutaneously. DA-1726 as a dual agonist of GLP-1 receptors (GLP1R) and glucagon receptors (GCGR), leading to weight loss through reduced appetite and increased energy expenditure. DA-1726 has a well understood mechanism and, in preclinical mice models, resulted in improved weight loss compared to semaglutide and cotadutide (another OXM analogue).

About NeuroBo Pharmaceuticals

NeuroBo Pharmaceuticals, Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1241 for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Type 2 Diabetes Mellitus (T2DM), and is developing DA-1726 for the treatment of obesity. DA-1241 is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In preclinical studies, DA-1241 demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists.

For more information, please visit www.neurobopharma.com.

Forward Looking Statements

Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "intends", "projects," "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with NeuroBo's ability to execute on its commercial strategy; the timeline for regulatory submissions; ability to obtain regulatory approval through the development steps of NeuroBo's current and future product candidates, the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of NeuroBo; the cooperation of our contract manufacturers, clinical study partners and others involved in the development of NeuroBo's current and future product candidates; potential negative interactions between our product candidates and any other products with which they are combined for treatment; NeuroBo's ability to initiate and complete clinical trials on a timely basis; our ability to recruit subjects for its clinical trials; whether NeuroBo receives results from NeuroBo's clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; effects of changes in applicable laws or regulations; effects of changes to NeuroBo's stock price on the terms of the license agreement and any future fundraising; and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. NeuroBo does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contacts:

NeuroBo Pharmaceuticals
Marshall H. Woodworth
Interim Chief Financial Officer
+1-857-299-1033
marshall.woodworth@neurobopharma.com

Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com

 

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SOURCE NeuroBo Pharmaceuticals, Inc.

What is the ticker symbol for NeuroBo Pharmaceuticals, Inc.?

The ticker symbol for NeuroBo Pharmaceuticals, Inc. is NRBO.

What is the focus of NeuroBo Pharmaceuticals, Inc.?

NeuroBo Pharmaceuticals, Inc. is focused on transforming cardiometabolic diseases.

What is the name of the novel drug being tested in the Phase 1 trial?

The novel drug being tested is DA-1726.

When is the first patient expected to be randomized for the Phase 1 trial?

The first patient is expected to be randomized in the second quarter of 2024.

What are the primary and secondary endpoints of the Phase 1 trial?

The primary endpoint is to assess the safety and tolerability of DA-1726. Secondary endpoints include pharmacokinetics, metabolic parameters, cardiac parameters, and more.