NeuroBo Pharmaceuticals Announces FDA Clearance of IND for a Phase 1 Clinical Trial of DA-1726 for the Treatment of Obesity

Rhea-AI Summary

NeuroBo Pharmaceuticals, Inc. has announced the clearance of its Investigational New Drug (IND) application for DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist. Preclinical studies have shown that DA-1726 elicits superior weight loss compared to Semaglutide (Wegovy™) and similar weight loss compared to Tirzepatide (Mounjaro™), while consuming more food. The company plans to initiate a Phase 1 clinical trial for the treatment of obesity in the first half of 2024.

Medical Research Analyst

The FDA's clearance of the IND application for NeuroBo's DA-1726 marks a significant milestone in the development of obesity treatments. The dual agonist approach, targeting both the GLP1R and GCGR, is noteworthy as it proposes a differentiated mechanism of action compared to existing therapies like semaglutide and tirzepatide. This could potentially offer a competitive advantage in terms of efficacy and tolerability, which are critical factors in the adoption of new therapeutics. The preclinical data suggesting superior weight loss and higher food consumption indicates a unique pharmacological profile that may translate into better patient compliance and fewer gastrointestinal side effects, a common issue with current GLP-1 agonists.

From an investment perspective, the progression of DA-1726 into Phase 1 trials is a positive development for NeuroBo Pharmaceuticals, potentially increasing the company's valuation. However, it's crucial to note that the drug is still in early stages and the transition from preclinical to clinical efficacy is uncertain. Investors should consider the high attrition rates in drug development, particularly in the obesity market, which has seen many promising candidates fail in later-stage trials. The focus on safety and tolerability in the primary endpoint of the upcoming trial underscores the importance of these attributes in the regulatory and market success of new drugs.

Financial Analyst

The initiation of the Phase 1 clinical trial for DA-1726 could have implications for NeuroBo's financial health and stock performance. The biotech sector is highly sensitive to clinical trial milestones and positive results from the trial could lead to stock appreciation. Conversely, any negative outcomes or delays can have a detrimental effect. The market for obesity treatments is substantial and a successful entry by DA-1726 could capture a significant market share, considering the current limitations of existing treatments. The investment required for the trial and subsequent studies will be substantial and the company's ability to fund these activities through partnerships, funding rounds, or other means will be critical to its continued operation and growth.

Investors should monitor the company's burn rate and capital-raising activities, as these will be important indicators of its ability to sustain the development of DA-1726. It's also important to evaluate the competitive landscape, as other companies are also working on similar treatments. Any changes in the competitive environment could impact NeuroBo's market opportunity and strategic positioning.

Market Research Analyst

Obesity is a growing global health crisis and the demand for effective treatment options is on the rise. The therapeutic potential of DA-1726, as indicated by preclinical studies, positions it as a promising candidate in a lucrative market. However, market adoption depends not only on clinical success but also on factors such as pricing, reimbursement policies and physician prescribing habits. The exploratory endpoints of the Phase 1 trial, including effects on metabolic and cardiac parameters, are aligned with the broader trends in obesity management, which emphasize holistic health improvements beyond weight loss alone.

The current obesity treatment market is dominated by a few key players and the entry of a new drug with a differentiated profile could disrupt the existing dynamics. Market analysts will be keenly watching the progress of DA-1726's clinical development for potential shifts in market shares. It is also important to consider the potential for strategic alliances or acquisition interest from larger pharmaceutical companies looking to expand their cardiometabolic portfolios.

Preclinical Studies Show DA-1726 Elicits Superior Weight Loss Compared to Semaglutide (Wegovy™) and Similar Weight Loss Compared to Tirzepatide (Mounjaro™), While Consuming More Food

Initiation of Phase 1 Clinical Trial Expected to Occur in the First Half of 2024

CAMBRIDGE, Mass., Feb. 1, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR). The company plans to initiate a Phase 1 clinical trial, for the treatment of obesity, in the first half of this year.

"Clearance of the IND for DA-1726 allows us to proceed with the Phase 1 program for this novel GLP-1 and glucagon dual receptor, a potential new treatment to address the significant obesity market," stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. "As previously reported, preclinical evidence has shown that DA-1726 results in persistent weight loss in diet-induced obese mice and rats by reducing food intake while increasing energy expenditure. Additionally, 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 (Mounjaro™). Based on these results, it is our belief that DA-1726 may have a better tolerability profile than currently available GLP-1 agonists due to its balanced activation of GLP1R and glucagon receptors. We look forward to dosing the first patient with DA-1726 during the first half of this year with an expected data readout in the first half of 2025."

The Phase 1 trial is designed to be a randomized, placebo-controlled, double-blind, sequential parallel group 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 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.

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, dual oxyntomodulin (OXM) analog that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) for the treatment of obesity. 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.

FAQ

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

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

What is the name of the novel dual oxyntomodulin (OXM) analog agonist developed by NeuroBo Pharmaceuticals, Inc.?

The novel dual oxyntomodulin (OXM) analog agonist developed by NeuroBo Pharmaceuticals, Inc. is DA-1726.

When is the initiation of the Phase 1 clinical trial expected to occur?

The initiation of the Phase 1 clinical trial for the treatment of obesity is expected to occur in the first half of 2024.

What are the primary and secondary endpoints of the Phase 1 trial for DA-1726?

The primary endpoint is to assess the safety and tolerability of DA-1726, while the secondary endpoints include the pharmacokinetics (PK) of DA-1726 and its effect on metabolic and cardiac parameters, fasting lipid levels, body weight, and other measures.

What are the expected outcomes of the Phase 1 trial for DA-1726?

The expected outcomes of the Phase 1 trial include data on the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of DA-1726 in obese, otherwise healthy subjects.