No Significant Issues Encountered During the
Single Ascending Dose (SAD) Study, Allowing for Previously Reported
Accelerated Start to Multiple Ascending Dose (MAD) Part 2
Top Line Data Readout from SAD Part 1 Expected
in the Third Quarter of 2024, and from the MAD Part 2 in the First
Quarter of 2025
CAMBRIDGE, Mass., Aug. 13,
2024 /PRNewswire/ -- NeuroBo Pharmaceuticals,
Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company
focused on transforming cardiometabolic diseases, today announced
the completion of enrollment of the single ascending dose (SAD)
Part 1 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. A total of 45 participants
have been enrolled and randomized into one of 5 cohorts, with each
cohort having been randomized in a 6:3 ratio of DA-1726 to
placebo.
"Completion of enrollment in Part 1 of this Phase 1 clinical
trial evaluating DA-1726 for the treatment of obesity marks the
achievement of yet another key milestone for NeuroBo and reflects
our ongoing commitment to transforming the treatment of
cardiometabolic diseases with differentiated therapies," stated
Hyung Heon Kim, President and Chief
Executive Officer of NeuroBo. "Notably, we encountered no
significant issues during the SAD study, allowing us to begin the
multiple ascending dose (MAD) study ahead of schedule. As
previously reported, strong pre-clinical data has shown superior
weight loss with DA-1726 versus semaglutide (Wegovy®) and similar
weight reduction while consuming more food compared to tirzepatide
(Zepbound®). Data presented at the American Diabetes Association
84th Scientific Sessions showed that DA-1726
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 while also exhibiting superior glucose lowering. These
factors lead us to believe that DA-1726 may eventually become a
best-in-class obesity drug with a better tolerability profile than
currently marketed GLP-1 agonists, and those now in late-stage
clinical trials, based on its balanced activation of GLP1R and
glucagon receptors, while increasing energy expenditure."
Mr. Kim continued, "Our estimated timelines for this program
remain unchanged. We expect to report top-line data from the SAD
Part 1 portion of the Phase 1 clinical trial in the third quarter
of this year and top-line data from the MAD Part 2 in the first
quarter of 2025. Further, upon clearance of an updated
Investigational New Drug (IND) application with the U.S. Food and
Drug Administration (FDA), we expect to dose the first patient in
the planned Part 3 of the trial during the third quarter of 2025,
providing an interim data readout in or around mid-2026 and issuing
top-line results in the second half of 2026."
The Phase 1 trial is currently designed to be a randomized,
placebo-controlled, double-blind 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 2, currently enrolling subjects, is designed
as a MAD study, and is 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 first patient in the MAD study was dosed
ahead of schedule, in late June, as previously reported.
The primary endpoint of the Phase 1 trial 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-1726 for the treatment of obesity, and is
developing DA-1241 for the treatment of Metabolic
Dysfunction-Associated Steatohepatitis (MASH). 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.
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.
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", "potential", "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.