NeuroBo Pharmaceuticals Submits IND Application to the FDA for a Phase 1 Clinical Trial of DA-1726 for the Treatment of Obesity
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Insights
The submission of an IND application for DA-1726 by NeuroBo Pharmaceuticals represents a critical step in the development pipeline for new therapeutic agents, particularly in the field of cardiometabolic diseases. The unique mechanism of action of DA-1726, as a dual oxyntomodulin analog agonist targeting both GLP1R and GCGR, positions it as a potentially significant player in the obesity treatment market. The preclinical success of DA-1726 in reducing food intake and increasing energy expenditure and its comparison to existing treatments such as semaglutide and tirzepatide, suggests a competitive edge that could disrupt current treatment paradigms.
From a medical research perspective, the balanced activation of GLP-1 and glucagon receptors by DA-1726 may indeed lead to better glycemic control and tolerability, which are key factors in the long-term management of obesity and related metabolic disorders. The design of the Phase 1 trial, with its focus on safety, tolerability, pharmacokinetics and pharmacodynamics, is robust and will provide crucial data on the compound's effects in humans. The trial's structure, including SAD and MAD studies, is standard for early-phase clinical trials and will yield insights into optimal dosing regimens and potential side effects.
NeuroBo Pharmaceuticals' advancement into Phase 1 clinical trials for DA-1726 is a notable event for investors, as it marks the transition from preclinical research to human testing, which can significantly affect the company's valuation. The obesity treatment market is a high-value sector with substantial growth potential, given the increasing prevalence of obesity worldwide. A successful entry by DA-1726 could capture a sizeable market share, especially if it demonstrates superior efficacy or safety profiles compared to current market leaders like semaglutide and tirzepatide.
Financially, the costs associated with Phase 1 trials are substantial and the outcomes of these trials will likely influence future funding needs and partnership opportunities. Stakeholders should monitor the progress of the trial closely, as positive results could lead to stock price appreciation, while any setbacks might have the opposite effect. It's also important to consider the long development timelines in biotechnology, with data readouts not expected until the first half of 2025, which implies a long-term investment horizon for those considering stakes in NeuroBo.
The submission of the IND for DA-1726 by NeuroBo Pharmaceuticals could signal a new direction in the competitive landscape of obesity treatments. Market research indicates a growing demand for effective obesity therapies and the dual-action mechanism of DA-1726 could meet an unmet need in this space. If the clinical trials demonstrate significant benefits over existing treatments, DA-1726 could potentially alter market dynamics by offering a new standard of care.
Understanding the preferences and behaviors of healthcare providers and patients will be crucial for NeuroBo as they navigate the trial and potential market entry. The company will need to establish strong marketing strategies, highlighting the advantages of DA-1726 over competitors, to penetrate the market effectively. Additionally, payer acceptance and reimbursement policies will be key factors in the adoption of DA-1726, should it receive FDA approval.
"Filing of the IND for DA-1726 is as a seminal event in the development of this GLP-1 and glucagon dual receptor, bringing it one step closer to the clinic as a potential new treatment to address the significant obesity market," stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. "Preclinical evidence shows that DA-1726 reduced food intake while also increasing energy expenditure, which resulted in persistent weight loss in diet-induced obese mice and rats. Importantly, in mouse models, DA-1726 showed superior weight loss compared to semaglutide (Wegovy™). Additionally, the administration of DA-1726 resulted in similar weight reduction while consuming more food compared to tirzepatide (Mounjaro™). It is our belief that DA-1726's balanced activation between GLP-1 and glucagon receptors, may lead to better glycemic control and may have a better tolerability profile than current GLP-1 agonists. We look forward to initiating the clinical development for DA-1726, with the first dose expected to be administered in the first half of 2024 and 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 Non-Alcoholic Steatohepatitis (NASH) 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.
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