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 84th 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.