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.