NeuroBo Pharmaceuticals Doses First Patient in the MAD Part 2 of Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity

Rhea-AI Summary

NeuroBo Pharmaceuticals (Nasdaq: NRBO) has dosed the first patient in Part 2 of its Phase 1 clinical trial of DA-1726, a dual oxyntomodulin analog agonist for obesity treatment. This MAD study, expected to enroll 36 participants, will investigate safety, tolerability, and pharmacokinetics, with top-line data anticipated in Q1 2025. Part 3 of the trial, assessing weight loss and dietary changes over 24 weeks, will begin in Q3 2025, with interim data expected mid-2026. A recent $70 million financing will support the clinical development. Pre-clinical models showed DA-1726's superior weight loss compared to other drugs. The trial aims to establish DA-1726 as a best-in-class obesity treatment.

Positive

• Dosing of the first patient in MAD Part 2 ahead of schedule.
• Pre-clinical models showed superior weight loss of DA-1726 compared to semaglutide and tirzepatide.
• Recent $70 million financing ensures funding for clinical milestones.
• Top-line data from SAD Part 1 expected in Q3 2024, from MAD Part 2 in Q1 2025.
• Planned Part 3 to assess comprehensive weight loss metrics over 24 weeks starting Q3 2025.

Negative

• None.

Insights

Medical Research Analyst

NeuroBo Pharmaceuticals' progress in the clinical trials for DA-1726 is very promising for the treatment of obesity. The fact that the medication functions as both a GLP-1 receptor and glucagon receptor agonist makes it a novel therapy in the market. This dual mechanism is designed to balance glucose levels while promoting weight loss, potentially offering significant advantages over current drugs like semaglutide and tirzepatide.

The early results from pre-clinical trials, which indicate superior weight loss and better glucose control, are very encouraging. However, results from human trials will be critical to validate these findings. The ongoing multiple ascending dose (MAD) study is crucial, as it will help determine the safety and optimal dosing of DA-1726 in humans. The planned Part 3 study will further assess efficacy in terms of weight loss and other metabolic parameters, which will be pivotal in positioning DA-1726 in the obesity treatment landscape.

For stakeholders, the recent $70 million financing ensures that NeuroBo has the funds necessary to complete these critical trials. This financial backing is particularly important as it mitigates the risks associated with potential cash flow issues, allowing the company to focus on clinical milestones without distraction.

Financial Analyst

The recent $70 million financing is a strong indicator of confidence in NeuroBo Pharmaceuticals' DA-1726 drug candidate. The financing structure, which includes $20 million upfront and $50 million in clinical milestone-based warrants, is strategically sound. It provides immediate funds while aligning future financial support with the achievement of clinical milestones, thereby reducing financial risk.

From an investment perspective, the company's commitment to advancing DA-1726 through its clinical stages is a positive signal. It shows a clear pathway towards potential commercialization, which could significantly enhance shareholder value if successful. The timing of the upcoming data readouts—expected in the third quarter of 2024 and first quarter of 2025—offers clear milestones for investors to watch.

However, it's important to note the inherent risks associated with clinical trials. Any setbacks in the clinical development stages could adversely affect the stock. Investors should keep an eye on the progress of these trials and the safety and efficacy data that will emerge.

Top-Line Data Readout From the Single Ascending Dose Part 1 Expected in the Third Quarter of 2024, and From the Multiple Ascending Dose Part 2 in the First Quarter of 2025

Planned Part 3 Will Assess Total Weight Loss at 24 Weeks, Exploring Maximum Titratable Dose and Dietary Changes; Interim Data Readout Expected Mid-2026 with Top-Line Data in the Second Half of 2026

Recent Financing of up to $70 million Will Fund the Ongoing Clinical Development of DA-1726

CAMBRIDGE, Mass., June 26, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced dosing of the first patient in the multiple ascending dose (MAD) Part 2 of its 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.

"Dosing of the first patient in Part 2 of this trial, late in the second quarter, ahead of schedule, is a further reflection of our strong commitment to swiftly advancing the clinical development of DA-1726, which holds promise as a highly differentiated therapy for the treatment of obesity," stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. "As we have noted previously, in pre-clinical mouse models, DA-1726 showed superior weight loss versus semaglutide (Wegovy®) and resulted in similar weight reduction while consuming more food compared to tirzepatide (Zepbound®). Additionally, as we presented at the American Diabetes Association 84^th Scientific Sessions, DA-1726 also demonstrated superior weight loss, compared to survodutide, a drug with the same mechanism of action, while also demonstrating retention of relative lean body mass preservation compared to survodutide and exhibiting superior glucose lowering. Based on this evidence, we believe that DA-1726 may potentially distinguish itself as a best-in-class obesity drug with a better tolerability profile than currently marketed GLP-1 agonists, as well as those in late-stage clinical trials, given its balanced activation of GLP1R and glucagon receptors, while increasing energy expenditure. Both Part 1 and Part 2 of the Phase 1 trial are proceeding well, and we anticipate reporting top-line data from the SAD Part 1 during the third quarter of this year, and from the MAD Part 2 in the first quarter of 2025.

"We are now well capitalized to execute on our upcoming DA-1726 milestones following our recent, successful financing of up to $70 million in aggregate gross proceeds, with $20 million upfront and $50 million of clinical milestone-based warrants, which we expect will enable us to fully fund a planned multicenter, randomized, double-blind, placebo-controlled Part 3 of this Phase 1 trial, which would begin upon completion of Part 2. Part 3 will explore changes in baseline, at 24 weeks, for total weight loss, dietary changes, weight loss through fat or lean muscle mass reduction, maximum-tolerated individualized dose and other exploratory endpoints. We believe this planned Part 3 will help position the novel DA-1726 drug candidate as a potentially best-in-class GLP1R/GCGR dual agonist for the treatment of obesity. Upon clearance of an updated Investigational New Drug (IND) application with the U.S. Food and Drug Administration, we expect to dose the first patient in the third quarter of 2025, provide an interim data readout in or around mid-2026 and issue top-line results in the second half of 2026."

The Phase 1 trial is currently 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. The Part 1 SAD study is 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 is designed as a 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 Metabolic Dysfunction-Associated Steatohepatitis (MASH) that is to be administered once weekly subcutaneously. DA-1726 acts 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 pre-clinical mice models, resulted in improved weight loss compared to semaglutide and cotadutide (another OXM analogue). Additionally, in pre-clinical mouse models, DA-1726 elicited similar weight reduction, while consuming more food, compared tirzepatide and survodutide, while also preserving lean body mass and demonstrating improved lipid-lowering effects compared to survodutide.

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 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 pre-clinical 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 press 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 press release, including, without limitation, those risks associated with NeuroBo's ability to execute on its commercial strategy; the timeline for regulatory submissions; the 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 NeuroBo's contract manufacturers, clinical study partners and others involved in the development of NeuroBo's current and future product candidates; potential negative interactions between NeuroBo's 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; NeuroBo's 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; the effects of changes in applicable laws or regulations; the 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 NeuroBo's filings with the Securities and Exchange Commission, including NeuroBo's most recent Annual Report on Form 10-K. 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
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 significance of NeuroBo's dosing the first patient in MAD Part 2 for stock symbol NRBO?

Dosing the first patient in MAD Part 2 marks an important milestone in NeuroBo's Phase 1 trial for DA-1726, potentially advancing the treatment of obesity and impacting NRBO's stock positively.

When is the top-line data for SAD Part 1 of NeuroBo's DA-1726 expected to be released?

The top-line data for the Single Ascending Dose (SAD) Part 1 of NeuroBo's DA-1726 is expected to be released in the third quarter of 2024.

What funding has NeuroBo Pharmaceuticals secured for its DA-1726 clinical trials?

NeuroBo Pharmaceuticals has secured up to $70 million in recent financing to support the clinical development of DA-1726.

What are the expectations for the multiple ascending dose (MAD) Part 2 of NeuroBo's DA-1726 trial?

The MAD Part 2 of NeuroBo's DA-1726 trial is designed to enroll 36 participants, with top-line data expected in Q1 2025.

What is the purpose of Part 3 in NeuroBo's Phase 1 trial of DA-1726?

Part 3 of NeuroBo's Phase 1 trial will assess total weight loss at 24 weeks, exploring maximum titratable doses and dietary changes, with interim data expected mid-2026.