Data Revealed Favorable Safety, Tolerability
and Dose-Linear Pharmacokinetics (PK)
Top-Line Data Readout from the MAD Part 2
Expected in the First Quarter of 2025
Planned Phase 1 Part 3 Will Evaluate Early
Proof of Concept
CAMBRIDGE, Mass., Sept. 30,
2024 /PRNewswire/ -- NeuroBo Pharmaceuticals,
Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company
focused on transforming cardiometabolic diseases, today announced
positive top-line safety, tolerability, and dose-linear
pharmacokinetics (PK) data from 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.
In the SAD Part 1 of the Phase 1 clinical trial, a total of 45
obese, otherwise healthy participants were randomized in a
double-blind, 6:3 ratio of DA-1726 or placebo. Single ascending
doses were found to be safe and well tolerated, with no serious
adverse events. Only 5 subjects in the DA-1726 treatment group
reported adverse events (AEs) compared with 3 subjects in the
placebo group. A dose-linear PK profile was observed across the
investigated dose range. Additional cohorts are being added to the
SAD Part 1 to explore the maximum tolerated dose.
"The safety, tolerability and dose-linear PK data generated from
the Part 1 SAD trial are highly encouraging and allowed for the
accelerated initiation of our multiple ascending dose (MAD) study,"
stated Hyung Heon Kim, President and
Chief Executive Officer of NeuroBo. "In light of the strong safety
profile from the SAD Part 1 of the study, we are in the process of
adding one or more cohorts to further explore the maximum tolerated
dose, which will allow us to realize the full potential of DA-1726.
Based on the preclinical data generated to date, as well as
DA-1726's balanced activation of GLP1R and glucagon receptors,
which increases energy expenditure, we continue to believe that
DA-1726 may 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. We eagerly anticipate
reporting top-line data from the MAD Part 2 in the first quarter of
2025, which will give us an early read on clinical efficacy.
Additionally, we continue to plan Part 3 of the trial that will
explore early proof of concept."
The MAD Part 2 of the Phase 1 trial is a randomized,
placebo-controlled, double-blind study to investigate the safety,
tolerability, PK, and PD of multiple ascending doses of DA-1726 in
obese, otherwise healthy subjects. Part 2 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 is to 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 (Wegovy®) and
cotadutide (another OXM analogue). Additionally, in pre-clinical
mouse models, DA-1726 elicited similar weight reduction, while
consuming more food, compared tirzepatide (Zepbound®) and
survodutide (a drug with the same MOA), 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.