CAMBRIDGE, Mass., Dec. 28,
2023 /PRNewswire/ -- NeuroBo Pharmaceuticals,
Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company
focused on transforming cardiometabolic diseases, today announced
that it has submitted an Investigational New Drug (IND) application
to the U.S. Food and Drug Administration (FDA). The IND application
supports a 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.
"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.